<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717456</url>
  </required_header>
  <id_info>
    <org_study_id>11-1569</org_study_id>
    <secondary_id>R01HS018695</secondary_id>
    <nct_id>NCT01717456</nct_id>
  </id_info>
  <brief_title>Educational-Medical-Behavioral Treatment of Fecal Incontinence</brief_title>
  <acronym>FIX</acronym>
  <official_title>Conservative Treatment of Fecal Incontinence: Community-Based Effectiveness Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In previous studies at a university referral center the investigators demonstrated that a&#xD;
      multicomponent conservative treatment for fecal incontinence was effective. The treatment&#xD;
      combines patient education with medical management of diarrhea and constipation plus&#xD;
      behavioral training. The purpose of this study is to determine whether this treatment is&#xD;
      effective when delivered by home health care nurses to frail elderly patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fecal incontinence (FI) affects 9% of U.S. adults and occurs weekly or more often in 2.7%.&#xD;
      Prevalence increases with age reaching 15% by 70 years. FI has a devastating impact on&#xD;
      quality of life and substantially increases caregiver burden when patients have comorbid&#xD;
      conditions requiring caregiver assistance. The investigators propose an effectiveness trial&#xD;
      whose overall goal is to determine whether a conservative intervention which has been shown&#xD;
      to be effective in single-site studies will sustain its efficacy when disseminated to a home&#xD;
      bound population by home health care nurses. The treatment includes patient education about&#xD;
      the physiology of how continence is maintained, pelvic floor exercises, behavioral strategies&#xD;
      for preventing FI, and use of fiber or nonprescription medication to treat diarrhea or&#xD;
      constipation. To minimize drift when the treatment is disseminated to a large group of&#xD;
      providers, patient education and other basic components of treatment are included in a&#xD;
      printed training manual and are available to nurse providers on a website; however, nurse&#xD;
      supervision to individualize treatment remains important. The study will be carried out in 8&#xD;
      counties in central North Carolina which are served by the University of North Carolina Home&#xD;
      Health Care and Rex Home Health Care agencies (partners in this study). Nurses in these&#xD;
      agencies will be randomly assigned to two groups. For the first two years all patients of the&#xD;
      nurses in one group will receive the active intervention while all patients of nurses in the&#xD;
      other group will receive usual care plus a training manual and symptom monitoring to control&#xD;
      for expectancy. After two years, all patients in these home health care agencies will receive&#xD;
      the active intervention. After excluding patients with severe cognitive impairment and those&#xD;
      with stomas, the investigators estimate 252 - 340 patients with FI who are over age 50 will&#xD;
      receive treatment (at least 189 in active treatment and 63 controls). Specific aims are (1)&#xD;
      to show that the active treatment is more effective than the control treatment for improving&#xD;
      FI severity, patient quality of life, and caregiver burden, and that improvements are&#xD;
      maintained for at least 6 months; (2) to identify moderators of treatment effectiveness&#xD;
      (candidate variables are cognitive status, mobility impairment, willingness of family&#xD;
      caregiver to assist with treatment, anxiety, depression, age, and race); and (3) to explore&#xD;
      whether successful treatment of FI reduces the risk of nursing home referral.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment led sponsor to terminate study early.&#xD;
  </why_stopped>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fecal Incontinence Severity Index (FISI) at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adequate Relief of Fecal Incontinence at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>At the end of treatment, the subject is asked, &quot;Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]&quot;. A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate Relief of Fecal Incontinence at Follow Up</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>At follow up 6 months after the end of treatment, the subject is asked, &quot;Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]&quot;. A responder to treatment is a subject who answers &quot;yes&quot;. When applied to group analysis, a treatment is regarded as effective if the responder rate is at least 10% greater in the active treatment arm compared to the control arm. This measure is not recorded at baseline because it is undefined until treatment has been provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Severity Scale at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>Quality of life scale specific to fecal incontinence. Severity is one of 8 MHQ subscales. This subscale has a range of 0 to 100. Higher scores indicate greater severity of QOL impact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Severity Scale at Follow Up</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0 to 100. Higher scores indicate greater impact on quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Caregiver Burden Scale at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The 22-items ask about behaviors and feelings of caregivers on a 6-step ordinal scale (never to almost always). The scale is valid for caregivers of individuals with diverse chronic disabilities (dementia, advanced cancer, acquired brain injury). The scale has good internal consistency. Total scores range 0-66, and 21 or greater is interpreted as high burden (J Clin Epidemiol 2010;63:535-42). Subscales (role and personal strain) have been described but are unreliable so total scores were used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Caregiver Burden Scale at Follow Up</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The total score range is from 0 to 66. Higher scores indicate greater severity of burden on the family.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal Incontinence Frequency at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>OASIS question M1620: Bowel incontinence frequency. Response options are:&#xD;
0 - Very rarely or never has bowel incontinence&#xD;
- Less than once weekly&#xD;
- One to three times weekly&#xD;
- Four to six times weekly&#xD;
- On a daily basis&#xD;
- More often than once daily</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary Incontinence Status Change From Baseline to End of Treatment</measure>
    <time_frame>Baseline, end of treatment (week 6)</time_frame>
    <description>OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are:&#xD;
0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage)&#xD;
- Patient is incontinent&#xD;
- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission to Nursing Home at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>Was patient admitted to a nursing home for one or more days at any time between enrollment and follow-up 7-8 months after treatment onset.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Incontinence Impact at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Incontinence Impact at Follow Up</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Role Limitations at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Role Limitations at Follow Up</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Physical Limitations at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Physical Limitations at Follow Up</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Social Limitations at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Social Limitations at Follow Up</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Personal Relationships at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Personal Relationships at Follow Up</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Emotions at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Emotions at Follow Up</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Sleep Energy at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHQ Sleep Energy at Follow Up</measure>
    <time_frame>6 months after (6-Week) treatment ends</time_frame>
    <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cognitive Status at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are:&#xD;
0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently.&#xD;
- Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions.&#xD;
- Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility.&#xD;
- Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time.&#xD;
- Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Ambulation From Baseline to End of Treatment</measure>
    <time_frame>Baseline, End of Treatment (Week 6)</time_frame>
    <description>OASIS question M1860: Ambulation/locomotion: Current ability to walk safely, once in a standing position, or use a wheelchair, once in a seated position, on a variety of surfaces. Measure as a moderator of treatment effects. Responses:&#xD;
0. Able to independently walk on even and uneven surfaces and negotiate stairs with or without railings (i.e., needs no human assistance or assistive device).&#xD;
Requires use of a device (e.g., cane, walker) to walk alone or requires human supervision or assistance to negotiate stairs or steps or uneven surfaces.&#xD;
Able to walk only with the supervision or assistance of another person at all times.&#xD;
Chairfast, unable to ambulate but is able to wheel self independently.&#xD;
Chairfast, unable to ambulate and is unable to wheel self.&#xD;
Bedfast, unable to ambulate or be up in a chair.&#xD;
Higher scores represent improvement in ability to ambulate.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ability to Reach Toilet at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>OASIS question M1840: Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. Measure as moderator of treatment outcomes.&#xD;
A lower score is better.&#xD;
Responses:&#xD;
0. Able to get to and from the toilet and transfer independently with or without a device.&#xD;
When reminded, assisted, or supervised by another person, able to get to and from the toilet.&#xD;
Unable to get to and from the toilet but is able to use a bedside commode (with or without assistance).&#xD;
Unable to get to and from the toilet or bedside commode but is able to use a bedpan/urinal independently.&#xD;
Is totally dependent in toileting.</description>
  </other_outcome>
  <other_outcome>
    <measure>When is Patient Anxious at End of Treatment?</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>OASIS question M1720: When anxious (reported or observed within the last 14 days). Measured as moderator of treatment effects on ordinal scale. Higher scores indicate a greater level of anxiousness. Responses are:&#xD;
0 - None of the time&#xD;
- Less often than daily&#xD;
- Daily, but not constantly&#xD;
- All of the time</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression Screening at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>OASIS question M1730: Depression Screening. Measure as a moderator of treatment effectiveness on categorical scale. Possible responses are:&#xD;
0= No screening&#xD;
Screened for depression with PHQ2 measure&#xD;
Screened with PHQ2 and meets criteria for further evaluation of depression&#xD;
Screened and does not meet criteria for further evaluation of depression</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient's Living Situation at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>OASIS question M1100: Patient living situation: This is a measure that combines who lives with the patient and the frequency that assistance is available to them throughout the day. Responses are coded on a 1-15 scale. Measure this as a moderator of treatment effectiveness.</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment</measure>
    <time_frame>End of Treatment (Week 6)</time_frame>
    <description>OASIS question M2100, item A: Types and sources of assistance for ADLs. Measure as moderator of treatment effectiveness. Responses range from &quot;No assistance needed in this area&quot; to &quot;Assistance needed, but no Caregivers available&quot;. Ordinal scale with 6 levels:&#xD;
0= No assistance needed&#xD;
Caregiver provides assistance&#xD;
Caregiver needs training or support&#xD;
Caregiver is unlikely to provide assistance&#xD;
Unclear if caregiver will assist patient&#xD;
Assistance is needed but is not available</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Educational-Medical-Behavioral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.</description>
    <arm_group_label>Educational-Medical-Behavioral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fiber supplements</intervention_name>
    <description>Patients and caregivers will be taught to use fiber supplements to normalize stool consistency if patient reports diarrhea or constipation. Fiber supplements will be in the form of Metamucil beginning with 3.4 grams per day and increasing up to 13.6 grams per day if needed to control stool consistency.</description>
    <arm_group_label>Educational-Medical-Behavioral</arm_group_label>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Laxatives or anti-diarrheals</intervention_name>
    <description>Miralax at a dose of one packet (17 grams) daily may be used for constipation if unresponsive to fiber. Dose may be titrated up to two packets (34 grams) daily if needed.&#xD;
Imodium at a starting dose of 2 mg/day may be used for diarrhea if unresponsive to fiber. Dose of Imodium may be titrated down to 1 mg or up to 4 mg if needed.</description>
    <arm_group_label>Educational-Medical-Behavioral</arm_group_label>
    <other_name>Miralax (polyethylene glycol)</other_name>
    <other_name>Imodium (loperamide)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pelvic floor muscle exercises</intervention_name>
    <description>Patients will be taught how to perform pelvic floor muscle contractions during digital rectal examination by a nurse. They will be asked to squeeze 100 times daily.</description>
    <arm_group_label>Educational-Medical-Behavioral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tips on how to prevent fecal incontinence</intervention_name>
    <description>Examples of behavioral tips are &quot;Walk, don't run to the toilet&quot; and &quot;Squeeze before you lift objects or sneeze&quot;.</description>
    <arm_group_label>Educational-Medical-Behavioral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Daily diary</intervention_name>
    <description>Both groups will keep a daily diary, but amount of detail differs: Active comparator group records bowel accidents, bowel movements, Bristol Stool ratings of stool consistency, number of times they do pelvic floor exercises, study medications, and comments for the nurse to read. Placebo comparator group records only bowel accidents, bowel movements, and Bristol Stool scores.</description>
    <arm_group_label>Educational-Medical-Behavioral</arm_group_label>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protective pads or garments</intervention_name>
    <description>In both groups, patients will be permitted to use pads or protective garments to avoid embarrassment. They will be told that fecal leakage that is stopped by a pad or protective garment should still be recorded as fecal incontinence.</description>
    <arm_group_label>Educational-Medical-Behavioral</arm_group_label>
    <arm_group_label>Standard Care</arm_group_label>
    <other_name>Continence pads</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-reported fecal incontinence at least once a month&#xD;
&#xD;
          -  Family caregiver available and willing to participate in treatment sessions and&#xD;
             willing to assist patient with study procedures&#xD;
&#xD;
          -  Patients and caregivers willing to be interviewed by a research assistant in their&#xD;
             home on three occasions&#xD;
&#xD;
          -  Onset of fecal incontinence more than 3 months previously (i.e., not transient fecal&#xD;
             incontinence)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a stoma or fecal incontinence status is unknown&#xD;
&#xD;
          -  Has fecal incontinence less than monthly&#xD;
&#xD;
          -  Severe cognitive impairment (response of 4 on OASIS question M1700)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William E Whitehead, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>May 16, 2016</results_first_submitted>
  <results_first_submitted_qc>February 16, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2017</results_first_posted>
  <last_update_submitted>February 16, 2017</last_update_submitted>
  <last_update_submitted_qc>February 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of North Carolina, Chapel Hill</investigator_affiliation>
    <investigator_full_name>William (Bill) Whitehead, PhD</investigator_full_name>
    <investigator_title>Professor of Medicine and Adjunct Professor of OBGYN</investigator_title>
  </responsible_party>
  <keyword>Fecal incontinence</keyword>
  <keyword>Frail elders</keyword>
  <keyword>Home health care</keyword>
  <keyword>Nurse</keyword>
  <keyword>Patient education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loperamide</mesh_term>
    <mesh_term>Antidiarrheals</mesh_term>
    <mesh_term>Laxatives</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Insufficient data to be analyzed by an outside investigator.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Home Health Care (HHC) provided lists to the investigators of new patients who were screened by HHC using the OASIS Questionnaire. Research assistants identified eligible patients based on the OASIS questions and telephoned them to obtain verbal consent and to schedule a baseline assessment visit. Written consent was obtained at the baseline visit.</recruitment_details>
      <pre_assignment_details>Baseline data collection and written consent was obtained at a home visit prior to referring the patient to HHC for randomization and initiation of treatment. Only 19/31 who gave consent to the research assistant were randomized. 3 others were judged ineligible by HHC, and 9 dropped out while awaiting treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Educational-Medical-Behavioral</title>
          <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].</description>
        </group>
        <group group_id="P2">
          <title>Standard Care</title>
          <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>End of Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-Up 6 Months After End of Tx</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis population is limited to patients who were randomized after referral to Home Health Care.</population>
      <group_list>
        <group group_id="B1">
          <title>Educational-Medical-Behavioral</title>
          <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
        </group>
        <group group_id="B2">
          <title>Standard Care</title>
          <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86.11" spread="4.51"/>
                    <measurement group_id="B2" value="85.00" spread="3.61"/>
                    <measurement group_id="B3" value="85.83" spread="4.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fecal Incontinence Severity Index (FISI) at Baseline</title>
          <description>Subjects rated the frequency of 4 types of stool leakage (gas, mucus, liquid, and solid) over the prior month on a 6-stepscale. Possible responses were never, 1-3 times/ month, once/week, 2 or more times/week, once/day, and 2 or more times/day. Based on the average quality of life impact scores assigned by a reference group of 34 subjects with fecal incontinence, weights were assigned to each of these 4 responses and added together for a sum score. Range is 0-61. No guidance on what defines mild, moderate, or severe is available. Higher scores show more severe fecal incontinence.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.50" spread="12.22"/>
                    <measurement group_id="B2" value="22.75" spread="8.14"/>
                    <measurement group_id="B3" value="23.72" spread="2.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Manchester Health Questionnaire (MHQ) Severity Scale at Baseline</title>
          <description>The MHQ (Br J Obstetrics &amp; Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. The range of scores of each domain is 0-100, and higher scores indicate greater impairment. Means and SDs for a reference group of 154 FI patients were published.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.64" spread="17.76"/>
                    <measurement group_id="B2" value="50.00" spread="18.13"/>
                    <measurement group_id="B3" value="49.21" spread="17.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MHQ Incontinence Impact at Baseline</title>
          <description>The MHQ (Br J Obstetrics &amp; Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.27" spread="23.60"/>
                    <measurement group_id="B2" value="65.63" spread="26.52"/>
                    <measurement group_id="B3" value="57.89" spread="25.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MHQ Role Limitations at Baseline</title>
          <description>The MHQ (Br J Obstetrics &amp; Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.64" spread="26.49"/>
                    <measurement group_id="B2" value="50.00" spread="29.12"/>
                    <measurement group_id="B3" value="28.95" spread="32.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MHQ Physical Limitations at Baseline</title>
          <description>The MHQ (Br J Obstetrics &amp; Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.18" spread="21.91"/>
                    <measurement group_id="B2" value="50.00" spread="28.35"/>
                    <measurement group_id="B3" value="31.58" spread="28.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MHQ Social Limitations at Baseline</title>
          <description>The MHQ (Br J Obstetrics &amp; Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.67" spread="29.11"/>
                    <measurement group_id="B2" value="43.75" spread="35.57"/>
                    <measurement group_id="B3" value="28.07" spread="33.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MHQ Personal Relationships at Baseline</title>
          <description>The MHQ (Br J Obstetrics &amp; Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.33" spread="20.41"/>
                    <measurement group_id="B2" value="20.00" spread="32.60"/>
                    <measurement group_id="B3" value="13.64" spread="25.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MHQ Emotions at Baseline</title>
          <description>The MHQ (Br J Obstetrics &amp; Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.70" spread="15.49"/>
                    <measurement group_id="B2" value="51.04" spread="28.67"/>
                    <measurement group_id="B3" value="32.89" spread="26.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MHQ Sleep Energy at Baseline</title>
          <description>The MHQ (Br J Obstetrics &amp; Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.95" spread="14.00"/>
                    <measurement group_id="B2" value="23.44" spread="28.69"/>
                    <measurement group_id="B3" value="14.47" spread="22.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Zarit Caregiver Burden Scale at Baseline</title>
          <description>The Zarit Caregiver Burden Interview is a 22-item questionnaire to assess the perceived burden of taking care of another ill or physically impaired person. All items are answered on a 5-step ordinal scale (from never to nearly always). Higher scores depict greater burden on the family. The total score range is from 0 to 66.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.00" spread="42.43"/>
                    <measurement group_id="B2" value="18.33" spread="13.50"/>
                    <measurement group_id="B3" value="22.75" spread="14.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Frequency of fecal incontinence at Baseline</title>
          <description>OASIS question M1620. 6-level ordinal scale.&#xD;
0 = Never or rarely incontinent for stool&#xD;
= Less than 1/week&#xD;
= 1-3 days/week&#xD;
= 4-6 days/week&#xD;
= Daily stool leakage&#xD;
= Multiple times per day&#xD;
Higher scores represent worse outcomes.&#xD;
Data were missing for 2/11 in Group A and for 6/8 in Group B.</description>
          <population>Data were missing for 2/11 in Group A and 6/8 in Group B.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="B2" value="4.5" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="B3" value="2" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urinary Continence Status at Baseline</title>
          <description>OASIS Question M1610 is a 3-level ordinal scale.&#xD;
0 = No urinary incontinence&#xD;
= Incontinence for urine&#xD;
= Patient requires catheter&#xD;
Data are missing for 2/11 in Group A and 6/8 in Group B. Having a catheter is equivalent to having urinary incontinence; therefore, the investigators treated a 2 as equivalent to a 1.</description>
          <population>Data were missing for 2/11 in Group A and 6/8 for Group B.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B2" value="0.5" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B3" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cognitive Function at Baseline</title>
          <description>OASIS Question M1700. 5-level ordinal scale:&#xD;
0 = Alert and oriented&#xD;
= Requires prompting for unfamiliar activities&#xD;
= Requires assistance when task demands shifting attention&#xD;
= Requires assistance for routine tasks&#xD;
= Totally dependent&#xD;
Data missing for 2/11 in Group A and 6/8 in Group B. A higher number indicates a greater degree of cognitive impairment.</description>
          <population>Data were missing for 2/11 in Group A and 6/8 for Group B.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ambulation at Baseline</title>
          <description>OASIS Question M1860 is a 7-level ordinal scale.&#xD;
0 = Walks without assistance&#xD;
= Uses cane or other one-hand assistive device&#xD;
= Uses walker or other two-hand assistive device&#xD;
= Able to walk with assistance&#xD;
= Chair-fast but can wheel self around&#xD;
= Chair-fast and requires assistance&#xD;
= Bedfast&#xD;
Higher scores indicate a greater degree of physical impairment.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B2" value="0.5" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B3" value="0.2" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ability to use toilet at Baseline</title>
          <description>OASIS Question M1840 is a 5 level ordinal scale. Steps are:&#xD;
0 = Independent self-toileting&#xD;
= Uses toilet when reminded to do so&#xD;
= Unable to reach toilet but can use a bedside commode&#xD;
= Limited to use of a bedpan&#xD;
= Totally dependent in toileting&#xD;
Missing data for 2/11 in Group A and 6/8 in Group B.&#xD;
Higher scores indicate a greater degree of impairment in toileting behavior.</description>
          <population>Data were missing for 2/11 in Group A and 6/8 for Group B.</population>
          <units>participants</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>When is patient anxious at Baseline?</title>
          <description>OASIS Question M1720 is a 4-level ordinal scale. Responses are:&#xD;
0 = Never&#xD;
= Less than every day&#xD;
= Daily but not constantly&#xD;
= All the time&#xD;
Higher scores indicate a greater level of anxiousness.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Depression Screening at Baseline</title>
          <description>OASIS Question M1730 has 4 discrete categories. Possible responses are:&#xD;
0 = Patient was not screened for depression&#xD;
= Screened by PHQ2 depression scale&#xD;
= Meets criteria for further screening for depression&#xD;
= Does not meet criteria for further screening&#xD;
Higher scores indicate a greater level of depression.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Not screened for depression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screened by Patient Health Questionnaire 2 (PHQ2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Requires further evaluation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screened and does not need further evaluation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Living Situation at Baseline</title>
          <description>OASIS Question M1100 has 3 discrete categories which are:&#xD;
1 = Lives alone 6 = Lives with another person 11 = Lives in assisted living&#xD;
Scores are labels describing the patient's living situation.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Lives alone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lives with another adult</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lives in assisted living</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Source of Assistance with ADLs at Baseline</title>
          <description>OASIS Question M2100 has 5 discrete categories which are:&#xD;
0 = No assistance needed&#xD;
= Caregiver provides assistance for activities of daily living (ADLs)&#xD;
= Caregiver needs training or support&#xD;
= Caregiver is not likely to provide assistance&#xD;
= Unclear if caregiver will provide assistance&#xD;
= Assistance needed but none is available&#xD;
Higher scores indicate a greater need for assistance with ADLs.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>No assistance needed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregiver provides assistance</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregiver needs training or support</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregiver unlikely to provide assistance</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unclear if caregiver will assist patient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Assistance needed but not available</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Fecal Incontinence Severity Index (FISI) at End of Treatment</title>
        <description>At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>Analysis population includes all participants who provided end of treatment data to research assistants during a home visit. One subject from the EMB treatment did not provide data, and 1 subject from the SC group did not provide these data.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Fecal Incontinence Severity Index (FISI) at End of Treatment</title>
          <description>At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.</description>
          <population>Analysis population includes all participants who provided end of treatment data to research assistants during a home visit. One subject from the EMB treatment did not provide data, and 1 subject from the SC group did not provide these data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.00" spread="10.30"/>
                    <measurement group_id="O2" value="22.00" spread="9.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.05</p_value>
            <p_value_desc>No adjustment for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.0</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>6.72</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)</title>
        <description>At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>The analysis sample consists of all patients who provided data at the 6 month FU visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)</title>
          <description>At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.</description>
          <population>The analysis sample consists of all patients who provided data at the 6 month FU visit.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.86" spread="12.71"/>
                    <measurement group_id="O2" value="37.00" spread="21.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adequate Relief of Fecal Incontinence at End of Treatment</title>
        <description>At the end of treatment, the subject is asked, &quot;Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]&quot;. A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>Data not available for 1/11 Educational-Medical-Behavioral group subject and for 2/8 Standard Care subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Adequate Relief of Fecal Incontinence at End of Treatment</title>
          <description>At the end of treatment, the subject is asked, &quot;Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]&quot;. A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups.</description>
          <population>Data not available for 1/11 Educational-Medical-Behavioral group subject and for 2/8 Standard Care subjects.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes, Adequate Relief</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No, No Adequate Relief</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adequate Relief of Fecal Incontinence at Follow Up</title>
        <description>At follow up 6 months after the end of treatment, the subject is asked, &quot;Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]&quot;. A responder to treatment is a subject who answers &quot;yes&quot;. When applied to group analysis, a treatment is regarded as effective if the responder rate is at least 10% greater in the active treatment arm compared to the control arm. This measure is not recorded at baseline because it is undefined until treatment has been provided.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>Data not available for 3/7 Educational-Medical-Behavioral group subject and for 2/2 Standard Care subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Adequate Relief of Fecal Incontinence at Follow Up</title>
          <description>At follow up 6 months after the end of treatment, the subject is asked, &quot;Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]&quot;. A responder to treatment is a subject who answers &quot;yes&quot;. When applied to group analysis, a treatment is regarded as effective if the responder rate is at least 10% greater in the active treatment arm compared to the control arm. This measure is not recorded at baseline because it is undefined until treatment has been provided.</description>
          <population>Data not available for 3/7 Educational-Medical-Behavioral group subject and for 2/2 Standard Care subjects.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes, Adequate Relief</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No, no Adequate Relief</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Severity Scale at End of Treatment</title>
        <description>Quality of life scale specific to fecal incontinence. Severity is one of 8 MHQ subscales. This subscale has a range of 0 to 100. Higher scores indicate greater severity of QOL impact.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Severity Scale at End of Treatment</title>
          <description>Quality of life scale specific to fecal incontinence. Severity is one of 8 MHQ subscales. This subscale has a range of 0 to 100. Higher scores indicate greater severity of QOL impact.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.50" spread="28.41"/>
                    <measurement group_id="O2" value="55.00" spread="23.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Severity Scale at Follow Up</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0 to 100. Higher scores indicate greater impact on quality of life.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Severity Scale at Follow Up</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0 to 100. Higher scores indicate greater impact on quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.29" spread="25.40"/>
                    <measurement group_id="O2" value="47.50" spread="31.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Zarit Caregiver Burden Scale at End of Treatment</title>
        <description>Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The 22-items ask about behaviors and feelings of caregivers on a 6-step ordinal scale (never to almost always). The scale is valid for caregivers of individuals with diverse chronic disabilities (dementia, advanced cancer, acquired brain injury). The scale has good internal consistency. Total scores range 0-66, and 21 or greater is interpreted as high burden (J Clin Epidemiol 2010;63:535-42). Subscales (role and personal strain) have been described but are unreliable so total scores were used.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Caregiver Burden Scale at End of Treatment</title>
          <description>Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The 22-items ask about behaviors and feelings of caregivers on a 6-step ordinal scale (never to almost always). The scale is valid for caregivers of individuals with diverse chronic disabilities (dementia, advanced cancer, acquired brain injury). The scale has good internal consistency. Total scores range 0-66, and 21 or greater is interpreted as high burden (J Clin Epidemiol 2010;63:535-42). Subscales (role and personal strain) have been described but are unreliable so total scores were used.</description>
          <population>Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.00" spread="42.43"/>
                    <measurement group_id="O2" value="30.50" spread="23.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Zarit Caregiver Burden Scale at Follow Up</title>
        <description>Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The total score range is from 0 to 66. Higher scores indicate greater severity of burden on the family.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Caregiver Burden Scale at Follow Up</title>
          <description>Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The total score range is from 0 to 66. Higher scores indicate greater severity of burden on the family.</description>
          <population>Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.00" spread="14.00"/>
                    <measurement group_id="O2" value="25.50" spread="20.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fecal Incontinence Frequency at End of Treatment</title>
        <description>OASIS question M1620: Bowel incontinence frequency. Response options are:&#xD;
0 - Very rarely or never has bowel incontinence&#xD;
- Less than once weekly&#xD;
- One to three times weekly&#xD;
- Four to six times weekly&#xD;
- On a daily basis&#xD;
- More often than once daily</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>Analysis population consists of all patients who provided data at the end of treatment visit. Data is missing for 2/11 in Group A and 6/8 in Group B.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Fecal Incontinence Frequency at End of Treatment</title>
          <description>OASIS question M1620: Bowel incontinence frequency. Response options are:&#xD;
0 - Very rarely or never has bowel incontinence&#xD;
- Less than once weekly&#xD;
- One to three times weekly&#xD;
- Four to six times weekly&#xD;
- On a daily basis&#xD;
- More often than once daily</description>
          <population>Analysis population consists of all patients who provided data at the end of treatment visit. Data is missing for 2/11 in Group A and 6/8 in Group B.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urinary Incontinence Status Change From Baseline to End of Treatment</title>
        <description>OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are:&#xD;
0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage)&#xD;
- Patient is incontinent&#xD;
- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)</description>
        <time_frame>Baseline, end of treatment (week 6)</time_frame>
        <population>Analysis population consists of all patients who provided end of treatment data. Data were missing for 2/11 in Group A and 6/8 in Group B.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Urinary Incontinence Status Change From Baseline to End of Treatment</title>
          <description>OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are:&#xD;
0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage)&#xD;
- Patient is incontinent&#xD;
- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)</description>
          <population>Analysis population consists of all patients who provided end of treatment data. Data were missing for 2/11 in Group A and 6/8 in Group B.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0.50" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Admission to Nursing Home at End of Treatment</title>
        <description>Was patient admitted to a nursing home for one or more days at any time between enrollment and follow-up 7-8 months after treatment onset.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>Analysis sample was all patients who provided data at end of treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Admission to Nursing Home at End of Treatment</title>
          <description>Was patient admitted to a nursing home for one or more days at any time between enrollment and follow-up 7-8 months after treatment onset.</description>
          <population>Analysis sample was all patients who provided data at end of treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Admitted to nursing home</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not admitted to nursing home</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Incontinence Impact at End of Treatment</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Incontinence Impact at End of Treatment</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.50" spread="23.72"/>
                    <measurement group_id="O2" value="70.00" spread="20.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Incontinence Impact at Follow Up</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Incontinence Impact at Follow Up</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.71" spread="24.40"/>
                    <measurement group_id="O2" value="25.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Role Limitations at End of Treatment</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Role Limitations at End of Treatment</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.25" spread="28.90"/>
                    <measurement group_id="O2" value="57.50" spread="34.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Role Limitations at Follow Up</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Role Limitations at Follow Up</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.29" spread="19.67"/>
                    <measurement group_id="O2" value="12.50" spread="17.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Physical Limitations at End of Treatment</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Physical Limitations at End of Treatment</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.75" spread="31.87"/>
                    <measurement group_id="O2" value="60.00" spread="32.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Physical Limitations at Follow Up</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Physical Limitations at Follow Up</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.14" spread="18.90"/>
                    <measurement group_id="O2" value="31.25" spread="8.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Social Limitations at End of Treatment</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Social Limitations at End of Treatment</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.83" spread="26.77"/>
                    <measurement group_id="O2" value="48.33" spread="43.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Social Limitations at Follow Up</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Social Limitations at Follow Up</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.38" spread="6.30"/>
                    <measurement group_id="O2" value="4.17" spread="5.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Personal Relationships at End of Treatment</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Personal Relationships at End of Treatment</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="25.00" spread="35.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Personal Relationships at Follow Up</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Personal Relationships at Follow Up</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Emotions at End of Treatment</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Emotions at End of Treatment</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.17" spread="29.52"/>
                    <measurement group_id="O2" value="50.00" spread="38.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Emotions at Follow Up</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Emotions at Follow Up</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.10" spread="13.49"/>
                    <measurement group_id="O2" value="12.50" spread="5.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Sleep Energy at End of Treatment</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Sleep Energy at End of Treatment</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.00" spread="17.48"/>
                    <measurement group_id="O2" value="32.50" spread="20.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MHQ Sleep Energy at Follow Up</title>
        <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
        <time_frame>6 months after (6-Week) treatment ends</time_frame>
        <population>All subjects completing end of treatment home visit with research assistant.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>MHQ Sleep Energy at Follow Up</title>
          <description>Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.</description>
          <population>All subjects completing end of treatment home visit with research assistant.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.57" spread="6.10"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Cognitive Status at End of Treatment</title>
        <description>OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are:&#xD;
0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently.&#xD;
- Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions.&#xD;
- Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility.&#xD;
- Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time.&#xD;
- Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>Analysis population is all patients who provided data on this measure at end of treatment. Data were missing for 2/11 in Group A and 6/8 in Group B.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Status at End of Treatment</title>
          <description>OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are:&#xD;
0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently.&#xD;
- Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions.&#xD;
- Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility.&#xD;
- Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time.&#xD;
- Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium.</description>
          <population>Analysis population is all patients who provided data on this measure at end of treatment. Data were missing for 2/11 in Group A and 6/8 in Group B.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Ambulation From Baseline to End of Treatment</title>
        <description>OASIS question M1860: Ambulation/locomotion: Current ability to walk safely, once in a standing position, or use a wheelchair, once in a seated position, on a variety of surfaces. Measure as a moderator of treatment effects. Responses:&#xD;
0. Able to independently walk on even and uneven surfaces and negotiate stairs with or without railings (i.e., needs no human assistance or assistive device).&#xD;
Requires use of a device (e.g., cane, walker) to walk alone or requires human supervision or assistance to negotiate stairs or steps or uneven surfaces.&#xD;
Able to walk only with the supervision or assistance of another person at all times.&#xD;
Chairfast, unable to ambulate but is able to wheel self independently.&#xD;
Chairfast, unable to ambulate and is unable to wheel self.&#xD;
Bedfast, unable to ambulate or be up in a chair.&#xD;
Higher scores represent improvement in ability to ambulate.</description>
        <time_frame>Baseline, End of Treatment (Week 6)</time_frame>
        <population>Analysis sample consists of all patients who provided data for this questionnaire at the end of treatment. Two EMB subjects did not provide this data for unknown reasons, and 4 SC subjects did not provide this data for unknown reasons.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Ambulation From Baseline to End of Treatment</title>
          <description>OASIS question M1860: Ambulation/locomotion: Current ability to walk safely, once in a standing position, or use a wheelchair, once in a seated position, on a variety of surfaces. Measure as a moderator of treatment effects. Responses:&#xD;
0. Able to independently walk on even and uneven surfaces and negotiate stairs with or without railings (i.e., needs no human assistance or assistive device).&#xD;
Requires use of a device (e.g., cane, walker) to walk alone or requires human supervision or assistance to negotiate stairs or steps or uneven surfaces.&#xD;
Able to walk only with the supervision or assistance of another person at all times.&#xD;
Chairfast, unable to ambulate but is able to wheel self independently.&#xD;
Chairfast, unable to ambulate and is unable to wheel self.&#xD;
Bedfast, unable to ambulate or be up in a chair.&#xD;
Higher scores represent improvement in ability to ambulate.</description>
          <population>Analysis sample consists of all patients who provided data for this questionnaire at the end of treatment. Two EMB subjects did not provide this data for unknown reasons, and 4 SC subjects did not provide this data for unknown reasons.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ability to Reach Toilet at End of Treatment</title>
        <description>OASIS question M1840: Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. Measure as moderator of treatment outcomes.&#xD;
A lower score is better.&#xD;
Responses:&#xD;
0. Able to get to and from the toilet and transfer independently with or without a device.&#xD;
When reminded, assisted, or supervised by another person, able to get to and from the toilet.&#xD;
Unable to get to and from the toilet but is able to use a bedside commode (with or without assistance).&#xD;
Unable to get to and from the toilet or bedside commode but is able to use a bedpan/urinal independently.&#xD;
Is totally dependent in toileting.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>All patients who provided data for this measure at the end of treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Ability to Reach Toilet at End of Treatment</title>
          <description>OASIS question M1840: Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. Measure as moderator of treatment outcomes.&#xD;
A lower score is better.&#xD;
Responses:&#xD;
0. Able to get to and from the toilet and transfer independently with or without a device.&#xD;
When reminded, assisted, or supervised by another person, able to get to and from the toilet.&#xD;
Unable to get to and from the toilet but is able to use a bedside commode (with or without assistance).&#xD;
Unable to get to and from the toilet or bedside commode but is able to use a bedpan/urinal independently.&#xD;
Is totally dependent in toileting.</description>
          <population>All patients who provided data for this measure at the end of treatment.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>When is Patient Anxious at End of Treatment?</title>
        <description>OASIS question M1720: When anxious (reported or observed within the last 14 days). Measured as moderator of treatment effects on ordinal scale. Higher scores indicate a greater level of anxiousness. Responses are:&#xD;
0 - None of the time&#xD;
- Less often than daily&#xD;
- Daily, but not constantly&#xD;
- All of the time</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>Analysis population consists of all patients who provided end of treatment data.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>When is Patient Anxious at End of Treatment?</title>
          <description>OASIS question M1720: When anxious (reported or observed within the last 14 days). Measured as moderator of treatment effects on ordinal scale. Higher scores indicate a greater level of anxiousness. Responses are:&#xD;
0 - None of the time&#xD;
- Less often than daily&#xD;
- Daily, but not constantly&#xD;
- All of the time</description>
          <population>Analysis population consists of all patients who provided end of treatment data.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Depression Screening at End of Treatment</title>
        <description>OASIS question M1730: Depression Screening. Measure as a moderator of treatment effectiveness on categorical scale. Possible responses are:&#xD;
0= No screening&#xD;
Screened for depression with PHQ2 measure&#xD;
Screened with PHQ2 and meets criteria for further evaluation of depression&#xD;
Screened and does not meet criteria for further evaluation of depression</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>Analysis population consists of all patients providing data at end of treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Screening at End of Treatment</title>
          <description>OASIS question M1730: Depression Screening. Measure as a moderator of treatment effectiveness on categorical scale. Possible responses are:&#xD;
0= No screening&#xD;
Screened for depression with PHQ2 measure&#xD;
Screened with PHQ2 and meets criteria for further evaluation of depression&#xD;
Screened and does not meet criteria for further evaluation of depression</description>
          <population>Analysis population consists of all patients providing data at end of treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screened by PHQ2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meets criteria for further evaluation of depressio</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Does not meet criteria for further evaluation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient's Living Situation at End of Treatment</title>
        <description>OASIS question M1100: Patient living situation: This is a measure that combines who lives with the patient and the frequency that assistance is available to them throughout the day. Responses are coded on a 1-15 scale. Measure this as a moderator of treatment effectiveness.</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>Analysis population consists of all patients who provided data at end of treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Living Situation at End of Treatment</title>
          <description>OASIS question M1100: Patient living situation: This is a measure that combines who lives with the patient and the frequency that assistance is available to them throughout the day. Responses are coded on a 1-15 scale. Measure this as a moderator of treatment effectiveness.</description>
          <population>Analysis population consists of all patients who provided data at end of treatment</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lives alone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lives with another adult</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lives in assisted living</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment</title>
        <description>OASIS question M2100, item A: Types and sources of assistance for ADLs. Measure as moderator of treatment effectiveness. Responses range from &quot;No assistance needed in this area&quot; to &quot;Assistance needed, but no Caregivers available&quot;. Ordinal scale with 6 levels:&#xD;
0= No assistance needed&#xD;
Caregiver provides assistance&#xD;
Caregiver needs training or support&#xD;
Caregiver is unlikely to provide assistance&#xD;
Unclear if caregiver will assist patient&#xD;
Assistance is needed but is not available</description>
        <time_frame>End of Treatment (Week 6)</time_frame>
        <population>Analysis population consists of all patients who provided data at end of treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Educational-Medical-Behavioral</title>
            <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment</title>
          <description>OASIS question M2100, item A: Types and sources of assistance for ADLs. Measure as moderator of treatment effectiveness. Responses range from &quot;No assistance needed in this area&quot; to &quot;Assistance needed, but no Caregivers available&quot;. Ordinal scale with 6 levels:&#xD;
0= No assistance needed&#xD;
Caregiver provides assistance&#xD;
Caregiver needs training or support&#xD;
Caregiver is unlikely to provide assistance&#xD;
Unclear if caregiver will assist patient&#xD;
Assistance is needed but is not available</description>
          <population>Analysis population consists of all patients who provided data at end of treatment</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 month period from baseline visit to 6 month follow-up visit</time_frame>
      <desc>Adverse events were reported to the study team by the home health care nurses, often as a reason for discontinuation of treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Educational-Medical-Behavioral</title>
          <description>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [Mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].</description>
        </group>
        <group group_id="E2">
          <title>Standard Care</title>
          <description>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>FAERS</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Disability</sub_title>
                <description>Parkinson's disease, exacerbation</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination leading to small numbers of subjects analyzed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>William E. Whitehead, PhD, Professor of Medicine</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>(919) 843-6961</phone>
      <email>William_Whitehead@med.unc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717456
org study id: 11-1569
secondary id: R01HS018695
nct id: NCT01717456
lead sponsor: 
collaborator: 
has dmc: No
In previous studies at a university referral center the investigators demonstrated that a
      multicomponent conservative treatment for fecal incontinence was effective. The treatment
      combines patient education with medical management of diarrhea and constipation plus
      behavioral training. The purpose of this study is to determine whether this treatment is
      effective when delivered by home health care nurses to frail elderly patients.
Fecal incontinence (FI) affects 9% of U.S. adults and occurs weekly or more often in 2.7%.
      Prevalence increases with age reaching 15% by 70 years. FI has a devastating impact on
      quality of life and substantially increases caregiver burden when patients have comorbid
      conditions requiring caregiver assistance. The investigators propose an effectiveness trial
      whose overall goal is to determine whether a conservative intervention which has been shown
      to be effective in single-site studies will sustain its efficacy when disseminated to a home
      bound population by home health care nurses. The treatment includes patient education about
      the physiology of how continence is maintained, pelvic floor exercises, behavioral strategies
      for preventing FI, and use of fiber or nonprescription medication to treat diarrhea or
      constipation. To minimize drift when the treatment is disseminated to a large group of
      providers, patient education and other basic components of treatment are included in a
      printed training manual and are available to nurse providers on a website; however, nurse
      supervision to individualize treatment remains important. The study will be carried out in 8
      counties in central North Carolina which are served by the University of North Carolina Home
      Health Care and Rex Home Health Care agencies (partners in this study). Nurses in these
      agencies will be randomly assigned to two groups. For the first two years all patients of the
      nurses in one group will receive the active intervention while all patients of nurses in the
      other group will receive usual care plus a training manual and symptom monitoring to control
      for expectancy. After two years, all patients in these home health care agencies will receive
      the active intervention. After excluding patients with severe cognitive impairment and those
      with stomas, the investigators estimate 252 - 340 patients with FI who are over age 50 will
      receive treatment (at least 189 in active treatment and 63 controls). Specific aims are (1)
      to show that the active treatment is more effective than the control treatment for improving
      FI severity, patient quality of life, and caregiver burden, and that improvements are
      maintained for at least 6 months; (2) to identify moderators of treatment effectiveness
      (candidate variables are cognitive status, mobility impairment, willingness of family
      caregiver to assist with treatment, anxiety, depression, age, and race); and (3) to explore
      whether successful treatment of FI reduces the risk of nursing home referral.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Fecal Incontinence Severity Index (FISI) at End of Treatment
time frame: End of Treatment (Week 6)
description: At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.
measure: Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)
time frame: 6 months after (6-Week) treatment ends
description: At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.
measure: Adequate Relief of Fecal Incontinence at End of Treatment
time frame: End of Treatment (Week 6)
description: At the end of treatment, the subject is asked, "Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]". A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups.
measure: Adequate Relief of Fecal Incontinence at Follow Up
time frame: 6 months after (6-Week) treatment ends
description: At follow up 6 months after the end of treatment, the subject is asked, "Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]". A responder to treatment is a subject who answers "yes". When applied to group analysis, a treatment is regarded as effective if the responder rate is at least 10% greater in the active treatment arm compared to the control arm. This measure is not recorded at baseline because it is undefined until treatment has been provided.
measure: MHQ Severity Scale at End of Treatment
time frame: End of Treatment (Week 6)
description: Quality of life scale specific to fecal incontinence. Severity is one of 8 MHQ subscales. This subscale has a range of 0 to 100. Higher scores indicate greater severity of QOL impact.
measure: MHQ Severity Scale at Follow Up
time frame: 6 months after (6-Week) treatment ends
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0 to 100. Higher scores indicate greater impact on quality of life.
measure: Zarit Caregiver Burden Scale at End of Treatment
time frame: End of Treatment (Week 6)
description: Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The 22-items ask about behaviors and feelings of caregivers on a 6-step ordinal scale (never to almost always). The scale is valid for caregivers of individuals with diverse chronic disabilities (dementia, advanced cancer, acquired brain injury). The scale has good internal consistency. Total scores range 0-66, and 21 or greater is interpreted as high burden (J Clin Epidemiol 2010;63:535-42). Subscales (role and personal strain) have been described but are unreliable so total scores were used.
measure: Zarit Caregiver Burden Scale at Follow Up
time frame: 6 months after (6-Week) treatment ends
description: Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The total score range is from 0 to 66. Higher scores indicate greater severity of burden on the family.
measure: Fecal Incontinence Frequency at End of Treatment
time frame: End of Treatment (Week 6)
description: OASIS question M1620: Bowel incontinence frequency. Response options are:
0 - Very rarely or never has bowel incontinence
- Less than once weekly
- One to three times weekly
- Four to six times weekly
- On a daily basis
- More often than once daily
measure: Urinary Incontinence Status Change From Baseline to End of Treatment
time frame: Baseline, end of treatment (week 6)
description: OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are:
0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage)
- Patient is incontinent
- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)
measure: Admission to Nursing Home at End of Treatment
time frame: End of Treatment (Week 6)
description: Was patient admitted to a nursing home for one or more days at any time between enrollment and follow-up 7-8 months after treatment onset.
measure: MHQ Incontinence Impact at End of Treatment
time frame: End of Treatment (Week 6)
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Incontinence Impact at Follow Up
time frame: 6 months after (6-Week) treatment ends
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Role Limitations at End of Treatment
time frame: End of Treatment (Week 6)
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Role Limitations at Follow Up
time frame: 6 months after (6-Week) treatment ends
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Physical Limitations at End of Treatment
time frame: End of Treatment (Week 6)
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Physical Limitations at Follow Up
time frame: 6 months after (6-Week) treatment ends
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Social Limitations at End of Treatment
time frame: End of Treatment (Week 6)
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Social Limitations at Follow Up
time frame: 6 months after (6-Week) treatment ends
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Personal Relationships at End of Treatment
time frame: End of Treatment (Week 6)
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Personal Relationships at Follow Up
time frame: 6 months after (6-Week) treatment ends
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Emotions at End of Treatment
time frame: End of Treatment (Week 6)
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Emotions at Follow Up
time frame: 6 months after (6-Week) treatment ends
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Sleep Energy at End of Treatment
time frame: End of Treatment (Week 6)
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: MHQ Sleep Energy at Follow Up
time frame: 6 months after (6-Week) treatment ends
description: Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
measure: Cognitive Status at End of Treatment
time frame: End of Treatment (Week 6)
description: OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are:
0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently.
- Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions.
- Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility.
- Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time.
- Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium.
measure: Change in Ambulation From Baseline to End of Treatment
time frame: Baseline, End of Treatment (Week 6)
description: OASIS question M1860: Ambulation/locomotion: Current ability to walk safely, once in a standing position, or use a wheelchair, once in a seated position, on a variety of surfaces. Measure as a moderator of treatment effects. Responses:
0. Able to independently walk on even and uneven surfaces and negotiate stairs with or without railings (i.e., needs no human assistance or assistive device).
Requires use of a device (e.g., cane, walker) to walk alone or requires human supervision or assistance to negotiate stairs or steps or uneven surfaces.
Able to walk only with the supervision or assistance of another person at all times.
Chairfast, unable to ambulate but is able to wheel self independently.
Chairfast, unable to ambulate and is unable to wheel self.
Bedfast, unable to ambulate or be up in a chair.
Higher scores represent improvement in ability to ambulate.
measure: Ability to Reach Toilet at End of Treatment
time frame: End of Treatment (Week 6)
description: OASIS question M1840: Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. Measure as moderator of treatment outcomes.
A lower score is better.
Responses:
0. Able to get to and from the toilet and transfer independently with or without a device.
When reminded, assisted, or supervised by another person, able to get to and from the toilet.
Unable to get to and from the toilet but is able to use a bedside commode (with or without assistance).
Unable to get to and from the toilet or bedside commode but is able to use a bedpan/urinal independently.
Is totally dependent in toileting.
measure: When is Patient Anxious at End of Treatment?
time frame: End of Treatment (Week 6)
description: OASIS question M1720: When anxious (reported or observed within the last 14 days). Measured as moderator of treatment effects on ordinal scale. Higher scores indicate a greater level of anxiousness. Responses are:
0 - None of the time
- Less often than daily
- Daily, but not constantly
- All of the time
measure: Depression Screening at End of Treatment
time frame: End of Treatment (Week 6)
description: OASIS question M1730: Depression Screening. Measure as a moderator of treatment effectiveness on categorical scale. Possible responses are:
0= No screening
Screened for depression with PHQ2 measure
Screened with PHQ2 and meets criteria for further evaluation of depression
Screened and does not meet criteria for further evaluation of depression
measure: Patient's Living Situation at End of Treatment
time frame: End of Treatment (Week 6)
description: OASIS question M1100: Patient living situation: This is a measure that combines who lives with the patient and the frequency that assistance is available to them throughout the day. Responses are coded on a 1-15 scale. Measure this as a moderator of treatment effectiveness.
measure: Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment
time frame: End of Treatment (Week 6)
description: OASIS question M2100, item A: Types and sources of assistance for ADLs. Measure as moderator of treatment effectiveness. Responses range from "No assistance needed in this area" to "Assistance needed, but no Caregivers available". Ordinal scale with 6 levels:
0= No assistance needed
Caregiver provides assistance
Caregiver needs training or support
Caregiver is unlikely to provide assistance
Unclear if caregiver will assist patient
Assistance is needed but is not available
arm group label: Educational-Medical-Behavioral
arm group type: Active Comparator
description: Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
arm group label: Standard Care
arm group type: Placebo Comparator
description: Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
intervention type: Other
intervention name: Education
description: Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.
arm group label: Educational-Medical-Behavioral
intervention type: Dietary Supplement
intervention name: Fiber supplements
description: Patients and caregivers will be taught to use fiber supplements to normalize stool consistency if patient reports diarrhea or constipation. Fiber supplements will be in the form of Metamucil beginning with 3.4 grams per day and increasing up to 13.6 grams per day if needed to control stool consistency.
arm group label: Educational-Medical-Behavioral
arm group label: Standard Care
intervention type: Drug
intervention name: Laxatives or anti-diarrheals
description: Miralax at a dose of one packet (17 grams) daily may be used for constipation if unresponsive to fiber. Dose may be titrated up to two packets (34 grams) daily if needed.
Imodium at a starting dose of 2 mg/day may be used for diarrhea if unresponsive to fiber. Dose of Imodium may be titrated down to 1 mg or up to 4 mg if needed.
arm group label: Educational-Medical-Behavioral
other name: Miralax (polyethylene glycol)
other name: Imodium (loperamide)
intervention type: Behavioral
intervention name: Pelvic floor muscle exercises
description: Patients will be taught how to perform pelvic floor muscle contractions during digital rectal examination by a nurse. They will be asked to squeeze 100 times daily.
arm group label: Educational-Medical-Behavioral
intervention type: Behavioral
intervention name: Tips on how to prevent fecal incontinence
description: Examples of behavioral tips are "Walk, don't run to the toilet" and "Squeeze before you lift objects or sneeze".
arm group label: Educational-Medical-Behavioral
intervention type: Behavioral
intervention name: Daily diary
description: Both groups will keep a daily diary, but amount of detail differs: Active comparator group records bowel accidents, bowel movements, Bristol Stool ratings of stool consistency, number of times they do pelvic floor exercises, study medications, and comments for the nurse to read. Placebo comparator group records only bowel accidents, bowel movements, and Bristol Stool scores.
arm group label: Educational-Medical-Behavioral
arm group label: Standard Care
intervention type: Other
intervention name: Protective pads or garments
description: In both groups, patients will be permitted to use pads or protective garments to avoid embarrassment. They will be told that fecal leakage that is stopped by a pad or protective garment should still be recorded as fecal incontinence.
arm group label: Educational-Medical-Behavioral
arm group label: Standard Care
other name: Continence pads
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William E Whitehead, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of North Carolina, Chapel Hill
investigator full name: William (Bill) Whitehead, PhD
investigator title: Professor of Medicine and Adjunct Professor of OBGYN
mesh term: Fecal Incontinence
mesh term: Loperamide
mesh term: Antidiarrheals
mesh term: Laxatives
sharing ipd: No
ipd description: Insufficient data to be analyzed by an outside investigator.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small numbers of subjects analyzed.
point of contact: 