<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/NCT02183740</url>
  </required_header>
  <id_info>
    <org_study_id>HiST05</org_study_id>
    <nct_id>NCT02183740</nct_id>
  </id_info>
  <brief_title>Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence</brief_title>
  <acronym>EPSPFI</acronym>
  <official_title>Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence: a Cluster-randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Nurses Organisation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fecal incontinence (FI) has an increasing prevalence in the geriatric population which cannot&#xD;
      be explained by co-morbidity or anatomical and psychological changes of aging alone. In the&#xD;
      nursing home population previous studies suggest a prevalence between 10 and 69%, but is most&#xD;
      often reported to be between 40 and 55%. FI leads to a high direct and indirect economic&#xD;
      burden to the health-care system, and is an important cause og institutionalization of the&#xD;
      elderly patients. In addition, FI is associated with shame, social isolation and reduced&#xD;
      quality of life.&#xD;
&#xD;
      The importance of identifying treatable causes of FI in the frail elderly, rather than just&#xD;
      managing passively, is strongly emphasized. It is indicated that the level of awareness among&#xD;
      health personnel regarding appropriate assessment and treatment options is limited, and that&#xD;
      FI is considered a normal part of aging.&#xD;
&#xD;
      This study is based on the assumption that FI among nursing home patients can be prevented,&#xD;
      cured or ameliorated by offering nursing home staff knowledge of best practise. The primary&#xD;
      objective of the study is to test the hypothesis that a multifaceted educational program for&#xD;
      staff on assessment and treatment of FI, is associated with a reduction in patients'&#xD;
      frequency of FI.&#xD;
&#xD;
      The design of the study is a two armed cluster randomized trail (C-RCT) with a repeated&#xD;
      cross-sectional approach.The results will be analysed according to multilevel and&#xD;
      longitudinal modelling, and the study will use mixed effect models with the cluster treated&#xD;
      as a random effect.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">July 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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in frequency of fecal incontinence among patients</measure>
    <time_frame>Baseline, after 3 months and after 6 months</time_frame>
    <description>As measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012), section H: Continence. Because of relatively high risk of death and movement out of clusters, a repeated cross-sectional opproach to analyses will be used. Frequency of FI will thereby be analysed on a across-sectional group level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Remission of fecal incontinence among patients</measure>
    <time_frame>Baseline, after 3 months and after 6 months</time_frame>
    <description>For remission of FI a cohort approach to data analyses with only those identified with FI at baseline and still present at 3 and 6 month follow-up, will be included in the analyses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge among registered nurses and authorized social educators</measure>
    <time_frame>Baseline, after 3 months and after 6 months</time_frame>
    <description>Measured my a multiple choice test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FI-related concerns among patients</measure>
    <time_frame>Baseline, after 3 months and after 6 months</time_frame>
    <description>Relevant concerns as measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012) are: Mood and behavior, psycho-social wellbeing, urinary continence, constipation, diarrhea, skin condition, participation in activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlates of FI among patients</measure>
    <time_frame>Baseline, after 3 months and after 6 months</time_frame>
    <description>Relevant correlates as measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012) are: cognitive functioning, communication and vision, functionality and mobility, medical diagnosis, mouth and nutrition status, medications, treatment, examination/procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in behavior among health personnel</measure>
    <time_frame>Baseline, after 3 months and after 6 months</time_frame>
    <description>Measured by analyses of patient assessments and interventions as documented by health personnel in the electronic patient record and by the Fecal Incontinence in Nursing Home Patients questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Multifaceted educational program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A multifaceted educational program for nursing home staff consisting of:&#xD;
One seven hours educational meeting (interactive workshop) conducted in the nursing home. Theoretical input and case-base discussions considering guidelines for nurse led assessment og interventions of patients fecal incontinence.The content will be made available as educational material.&#xD;
Recruitment of one local opinion leader per nursing home unit.&#xD;
Seven educational outreach meetings (1 hour 30 minutes per meeting) during the three months intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control arm will not receive any educational program and will continue with usual care. Data with information about ordinary care will be gathered as part of the data collection procedure in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multifaceted educational program</intervention_name>
    <arm_group_label>Multifaceted educational program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Nursing homes with similar:&#xD;
&#xD;
          -  patients characteristcs&#xD;
&#xD;
          -  care staff/patients ratio&#xD;
&#xD;
          -  general practitioner consultancy&#xD;
&#xD;
        Patients:&#xD;
&#xD;
        - All patients on long term care residency (residency &gt;month)&#xD;
&#xD;
        Registered Nurses/authorized social educators:&#xD;
&#xD;
        - All working half time or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Nursing homes:&#xD;
&#xD;
        - With some kind of speciality (eks rehabilitation, dementia)&#xD;
&#xD;
        Patients:&#xD;
&#xD;
        - Short term care residency&#xD;
&#xD;
        Registered nurses/authorized social educator:&#xD;
&#xD;
          -  Working less than half time&#xD;
&#xD;
          -  Working only night shifts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne G Vinsnes, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sor Trondelag University College</name>
      <address>
        <city>Trondheim</city>
        <zip>7004</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Blekken LE, Vinsnes AG, Gjeilo KH, Morkved S, Salvesen O, Norton C, Nakrem S. Effect of a multifaceted educational program for care staff concerning fecal incontinence in nursing home patients: study protocol of a cluster randomized controlled trial. Trials. 2015 Mar 1;16:69. doi: 10.1186/s13063-015-0595-3.</citation>
    <PMID>25887238</PMID>
  </reference>
  <reference>
    <citation>Blekken LE, Nakrem S, Gjeilo KH, Norton C, Morkved S, Vinsnes AG. Feasibility, acceptability, and adherence of two educational programs for care staff concerning nursing home patients' fecal incontinence: a pilot study preceding a cluster-randomized controlled trial. Implement Sci. 2015 May 23;10:72. doi: 10.1186/s13012-015-0263-8.</citation>
    <PMID>26002520</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Education</keyword>
  <keyword>Nurses</keyword>
  <keyword>Nursing homes</keyword>
  <keyword>Fecal incontinence</keyword>
  <keyword>Cluster-randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 12, 2020</submitted>
    <returned>November 6, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02183740
org study id: HiST05
nct id: NCT02183740
lead sponsor: 
collaborator: 
has dmc: Yes
Fecal incontinence (FI) has an increasing prevalence in the geriatric population which cannot
      be explained by co-morbidity or anatomical and psychological changes of aging alone. In the
      nursing home population previous studies suggest a prevalence between 10 and 69%, but is most
      often reported to be between 40 and 55%. FI leads to a high direct and indirect economic
      burden to the health-care system, and is an important cause og institutionalization of the
      elderly patients. In addition, FI is associated with shame, social isolation and reduced
      quality of life.

      The importance of identifying treatable causes of FI in the frail elderly, rather than just
      managing passively, is strongly emphasized. It is indicated that the level of awareness among
      health personnel regarding appropriate assessment and treatment options is limited, and that
      FI is considered a normal part of aging.

      This study is based on the assumption that FI among nursing home patients can be prevented,
      cured or ameliorated by offering nursing home staff knowledge of best practise. The primary
      objective of the study is to test the hypothesis that a multifaceted educational program for
      staff on assessment and treatment of FI, is associated with a reduction in patients'
      frequency of FI.

      The design of the study is a two armed cluster randomized trail (C-RCT) with a repeated
      cross-sectional approach.The results will be analysed according to multilevel and
      longitudinal modelling, and the study will use mixed effect models with the cluster treated
      as a random effect.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in frequency of fecal incontinence among patients
time frame: Baseline, after 3 months and after 6 months
description: As measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012), section H: Continence. Because of relatively high risk of death and movement out of clusters, a repeated cross-sectional opproach to analyses will be used. Frequency of FI will thereby be analysed on a across-sectional group level.
measure: Remission of fecal incontinence among patients
time frame: Baseline, after 3 months and after 6 months
description: For remission of FI a cohort approach to data analyses with only those identified with FI at baseline and still present at 3 and 6 month follow-up, will be included in the analyses
measure: Change in knowledge among registered nurses and authorized social educators
time frame: Baseline, after 3 months and after 6 months
description: Measured my a multiple choice test
measure: Change in FI-related concerns among patients
time frame: Baseline, after 3 months and after 6 months
description: Relevant concerns as measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012) are: Mood and behavior, psycho-social wellbeing, urinary continence, constipation, diarrhea, skin condition, participation in activities
measure: Correlates of FI among patients
time frame: Baseline, after 3 months and after 6 months
description: Relevant correlates as measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012) are: cognitive functioning, communication and vision, functionality and mobility, medical diagnosis, mouth and nutrition status, medications, treatment, examination/procedures
measure: Change in behavior among health personnel
time frame: Baseline, after 3 months and after 6 months
description: Measured by analyses of patient assessments and interventions as documented by health personnel in the electronic patient record and by the Fecal Incontinence in Nursing Home Patients questionnaire
arm group label: Multifaceted educational program
arm group type: Experimental
description: A multifaceted educational program for nursing home staff consisting of:
One seven hours educational meeting (interactive workshop) conducted in the nursing home. Theoretical input and case-base discussions considering guidelines for nurse led assessment og interventions of patients fecal incontinence.The content will be made available as educational material.
Recruitment of one local opinion leader per nursing home unit.
Seven educational outreach meetings (1 hour 30 minutes per meeting) during the three months intervention period.
arm group label: Control
arm group type: No Intervention
description: The control arm will not receive any educational program and will continue with usual care. Data with information about ordinary care will be gathered as part of the data collection procedure in the study.
intervention type: Behavioral
intervention name: Multifaceted educational program
arm group label: Multifaceted educational program
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anne G Vinsnes, Professor
role: Principal Investigator
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
citation: Blekken LE, Vinsnes AG, Gjeilo KH, Morkved S, Salvesen O, Norton C, Nakrem S. Effect of a multifaceted educational program for care staff concerning fecal incontinence in nursing home patients: study protocol of a cluster randomized controlled trial. Trials. 2015 Mar 1;16:69. doi: 10.1186/s13063-015-0595-3.
PMID: 25887238
citation: Blekken LE, Nakrem S, Gjeilo KH, Norton C, Morkved S, Vinsnes AG. Feasibility, acceptability, and adherence of two educational programs for care staff concerning nursing home patients' fecal incontinence: a pilot study preceding a cluster-randomized controlled trial. Implement Sci. 2015 May 23;10:72. doi: 10.1186/s13012-015-0263-8.
PMID: 26002520
responsible party type: Sponsor
mesh term: Fecal Incontinence
sharing ipd: No
submitted: October 12, 2020
returned: November 6, 2020