<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/NCT04457206</url>
  </required_header>
  <id_info>
    <org_study_id>202001182</org_study_id>
    <nct_id>NCT04457206</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Collaborative Community Clinic for Persons With Spinal Cord Injury and Disease</brief_title>
  <acronym>SCI/D</acronym>
  <official_title>Evaluating the Effectiveness of the Collaborative Community Clinic for Persons With Spinal Cord Injury and Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator is evaluating data stored on the Collaborative Community Clinic data&#xD;
      repository (IRB #201811032). Researchers seek to evaluate the effectiveness of the&#xD;
      Collaborative Community Clinic (CCC), an occupational therapy student experiential learning&#xD;
      clinic for uninsured or under-insured people with spinal cord injury and disease (SCI/D),&#xD;
      using participants' initial and follow-up assessment batteries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All data reviewed will be pulled from the Collaborative Community Clinic (CCC) data&#xD;
      repository according to the data manual and procedures. A separate IRB was approved to review&#xD;
      outcomes from participants in the CCC to evaluate the effectiveness of the clinic. All&#xD;
      participants participated in an informed consent process to provide the option to have their&#xD;
      data stored in a data repository for aggregate review. If any participate chooses not to have&#xD;
      their data stored, it will not be stored or outcomes reviewed. However, participants are&#xD;
      still provided services through the CCC. Researchers anticipate up to 200 participants&#xD;
      participating in the registry over five years. All data will be data checked by a member of&#xD;
      the research team to limit errors and identification of missing data recorded. Statistical&#xD;
      analysis methods are to be determined upon completion of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 29, 2020</start_date>
  <completion_date type="Anticipated">January 29, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 29, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>12 Weeks</target_duration>
  <primary_outcome>
    <measure>General Self-Efficacy Scale</measure>
    <time_frame>pre-assessment before participation in the CCC and post-assessment following completion (approximately 12 weeks)</time_frame>
    <description>When completing the General Self-Efficacy Scale, clients rate a series of statements intended to measure feelings of self-efficacy such as &quot;I can always manage to solve difficult problems if I try hard enough&quot; on a scale of 1 (not at all true) to 4 (exactly true).It evaluates change in ability to self-manage health before and after participation in the Collaborative Community Clinic (CCC).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>pre-assessment before participation in the CCC and post-assessment upon completion of CCC participation (approximately 12 weeks)</time_frame>
    <description>The COPM measures perceived change in occupational performance. Each scale rated on a scale of 1 (low) to 10 (high). It is an evidence-based outcome measure designed to capture a participant's change in self-perception of performance in everyday living, over time before participation in the CCC and upon completion. The COPM has a broad focus on occupational performance in all areas of life, including self-care, leisure, and productivity, considering circumstances across the lifespan.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Promis 29 Global Health Measure</measure>
    <time_frame>pre-assessment prior to participation in the CCC and post-assessment upone completion of CCC participation (approximately 12 weeks)</time_frame>
    <description>The PROMIS-29 is a collection of four-item individual short forms assessing change in seven different domains: anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities, as well as a single pain intensity item. Individuals respond to the four items in each domain using a five-point Likert scale (5: without any difficulty, 1: unable to do). *T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community Participation Index (CPI):</measure>
    <time_frame>pre-assessment prior to participation in the CCC and post-assessment upon completion of the CCC participation (approximately 12 weeks)</time_frame>
    <description>The CPI is a valid and reliable assessment of change in involvement in life situations and individual control over participation. For each item, respondents rate frequency (in days, hours, or times per week, depending on the activity), whether it is important (yes/no), and to what extent they do the item (too much, enough, or not enough). The measure is used as a categorical variable using validated scores. Participation will be assessed at baseline and upon completion of the group and individual visits. A percentage satisfaction with community participation in achieved by totaling the number of items important to them, that they are doing enough of divided by the total number of activities that were listed as important to them and multiplying by 100. So, if 20 activities were important and 6 were being completed enough, they would have a 30% satisifaction rate (6/20 x100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a</measure>
    <time_frame>pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks)</time_frame>
    <description>short form depression scale - self-report - Change in scores with participation in the CCC. *T-Scores are used to interpret severity of depression by the following: 55 and under indicating slight to none, 55-59.9 mild, 60-69.9 moderate, and 70+ indicating severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Promis Item Bank v1.0 - Applied Cognition-Abilities Short Form 8a</measure>
    <time_frame>pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks)</time_frame>
    <description>short self-report of changes in cognition. *T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SCI Group and one-on-one services through student led occupational therapy clinic</intervention_name>
    <description>The Collaborative Community Clinic (CCC) students collaborate with Dr. Walker to conduct the spinal cord injury/disease (SCI/D) Health and Participation Program, which consists of a combination of groups and one-on-one OT sessions serving persons with spinal cord injury and disease who are un- or under-insured. The program includes a pre-assessment session, four groups, optional individual sessions and a post-survey. Group topics include bowel/bladder management, community mobility, advocacy, transportation, promoting intimacy, adaptive parenting and finding resources. Students are involved in recruiting participants, co-leading group sessions, treatment planning and implementation for individual sessions, and development of topic-specific materials.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Persons participating in the Collaborative Community Clinic are 18 years of age or older,&#xD;
        have the diagnosis of spinal cord injury or disease and are un-insured or under-insured for&#xD;
        occupational therapy services. For example, they may have Medicaid coverage, but no therapy&#xD;
        visits allowed. Or, they may be waiting on Medicare eligibility to kick in following&#xD;
        injury, which usually takes approximately two years. Persons may be referred following&#xD;
        discharge from the local rehabilitation center, be referred from other community agencies,&#xD;
        or self-referred.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age; diagnosis of spinal cord injury or disease, un-insured or&#xD;
             under-insured for occupational therapy services&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years of age, lack of SCI/D diagnosis, full insurance coverage for OT&#xD;
             services (ie. Medicare or Private Insurance)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Carla W Walker, OTD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University Program in Occupational Therapy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carla W Walker, OTD</last_name>
    <phone>3142737011</phone>
    <email>walkerc@wustl.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sue Tucker, OTD</last_name>
    <phone>314273-7008</phone>
    <email>tuckers@wustl.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carla W Walker, OTD</last_name>
      <phone>314-273-7011</phone>
      <email>walkerc@wustl.edu</email>
    </contact>
    <contact_backup>
      <last_name>Sue Tucker, OTD</last_name>
      <phone>3142737008</phone>
      <email>tuckers@wustl.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Carla W Walker, OTD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.pva.org/spinal-cord-injury-information</url>
    <description>paralyzed veterans of america website</description>
  </link>
  <reference>
    <citation>Garber SL, Rintala DH, Hart KA, Fuhrer MJ. Pressure ulcer risk in spinal cord injury: predictors of ulcer status over 3 years. Arch Phys Med Rehabil. 2000 Apr;81(4):465-71. doi: 10.1053/mr.2000.3889.</citation>
    <PMID>10768537</PMID>
  </reference>
  <reference>
    <citation>Gray DB, Hollingsworth HH, Stark SL, Morgan KA. Participation survey/mobility: psychometric properties of a measure of participation for people with mobility impairments and limitations. Arch Phys Med Rehabil. 2006 Feb;87(2):189-97. doi: 10.1016/j.apmr.2005.09.014.</citation>
    <PMID>16442971</PMID>
  </reference>
  <reference>
    <citation>Miller LC, Gottlieb M, Morgan KA, Gray DB. Interviews with employed people with mobility impairments and limitations: environmental supports impacting work acquisition and satisfaction. Work. 2014;48(3):361-72. doi: 10.3233/WOR-131784.</citation>
    <PMID>24284677</PMID>
  </reference>
  <results_reference>
    <citation>Craig A, Tran Y, Middleton J. Psychological morbidity and spinal cord injury: a systematic review. Spinal Cord. 2009 Feb;47(2):108-14. doi: 10.1038/sc.2008.115. Epub 2008 Sep 9.</citation>
    <PMID>18779835</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 18, 2023</last_update_submitted>
  <last_update_submitted_qc>May 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Carla Walker</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share participant data with other researchers at this time.</ipd_description>
  </patient_data>
  <!-- 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/NCT04457206
org study id: 202001182
nct id: NCT04457206
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigator is evaluating data stored on the Collaborative Community Clinic data
      repository (IRB #201811032). Researchers seek to evaluate the effectiveness of the
      Collaborative Community Clinic (CCC), an occupational therapy student experiential learning
      clinic for uninsured or under-insured people with spinal cord injury and disease (SCI/D),
      using participants' initial and follow-up assessment batteries.
All data reviewed will be pulled from the Collaborative Community Clinic (CCC) data
      repository according to the data manual and procedures. A separate IRB was approved to review
      outcomes from participants in the CCC to evaluate the effectiveness of the clinic. All
      participants participated in an informed consent process to provide the option to have their
      data stored in a data repository for aggregate review. If any participate chooses not to have
      their data stored, it will not be stored or outcomes reviewed. However, participants are
      still provided services through the CCC. Researchers anticipate up to 200 participants
      participating in the registry over five years. All data will be data checked by a member of
      the research team to limit errors and identification of missing data recorded. Statistical
      analysis methods are to be determined upon completion of the study.
observational model: Cohort
time perspective: Other
measure: General Self-Efficacy Scale
time frame: pre-assessment before participation in the CCC and post-assessment following completion (approximately 12 weeks)
description: When completing the General Self-Efficacy Scale, clients rate a series of statements intended to measure feelings of self-efficacy such as "I can always manage to solve difficult problems if I try hard enough" on a scale of 1 (not at all true) to 4 (exactly true).It evaluates change in ability to self-manage health before and after participation in the Collaborative Community Clinic (CCC).
measure: The Canadian Occupational Performance Measure (COPM)
time frame: pre-assessment before participation in the CCC and post-assessment upon completion of CCC participation (approximately 12 weeks)
description: The COPM measures perceived change in occupational performance. Each scale rated on a scale of 1 (low) to 10 (high). It is an evidence-based outcome measure designed to capture a participant's change in self-perception of performance in everyday living, over time before participation in the CCC and upon completion. The COPM has a broad focus on occupational performance in all areas of life, including self-care, leisure, and productivity, considering circumstances across the lifespan.
measure: Promis 29 Global Health Measure
time frame: pre-assessment prior to participation in the CCC and post-assessment upone completion of CCC participation (approximately 12 weeks)
description: The PROMIS-29 is a collection of four-item individual short forms assessing change in seven different domains: anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities, as well as a single pain intensity item. Individuals respond to the four items in each domain using a five-point Likert scale (5: without any difficulty, 1: unable to do). *T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points.
measure: Community Participation Index (CPI):
time frame: pre-assessment prior to participation in the CCC and post-assessment upon completion of the CCC participation (approximately 12 weeks)
description: The CPI is a valid and reliable assessment of change in involvement in life situations and individual control over participation. For each item, respondents rate frequency (in days, hours, or times per week, depending on the activity), whether it is important (yes/no), and to what extent they do the item (too much, enough, or not enough). The measure is used as a categorical variable using validated scores. Participation will be assessed at baseline and upon completion of the group and individual visits. A percentage satisfaction with community participation in achieved by totaling the number of items important to them, that they are doing enough of divided by the total number of activities that were listed as important to them and multiplying by 100. So, if 20 activities were important and 6 were being completed enough, they would have a 30% satisifaction rate (6/20 x100)
measure: PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a
time frame: pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks)
description: short form depression scale - self-report - Change in scores with participation in the CCC. *T-Scores are used to interpret severity of depression by the following: 55 and under indicating slight to none, 55-59.9 mild, 60-69.9 moderate, and 70+ indicating severe.
measure: Promis Item Bank v1.0 - Applied Cognition-Abilities Short Form 8a
time frame: pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks)
description: short self-report of changes in cognition. *T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points.
intervention type: Behavioral
intervention name: SCI Group and one-on-one services through student led occupational therapy clinic
description: The Collaborative Community Clinic (CCC) students collaborate with Dr. Walker to conduct the spinal cord injury/disease (SCI/D) Health and Participation Program, which consists of a combination of groups and one-on-one OT sessions serving persons with spinal cord injury and disease who are un- or under-insured. The program includes a pre-assessment session, four groups, optional individual sessions and a post-survey. Group topics include bowel/bladder management, community mobility, advocacy, transportation, promoting intimacy, adaptive parenting and finding resources. Students are involved in recruiting participants, co-leading group sessions, treatment planning and implementation for individual sessions, and development of topic-specific materials.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Carla W Walker, OTD
role: Principal Investigator
affiliation: Washington University Program in Occupational Therapy
last name: Carla W Walker, OTD
phone: 3142737011
email: walkerc@wustl.edu
last name: Sue Tucker, OTD
phone: 314273-7008
email: tuckers@wustl.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: https://www.pva.org/spinal-cord-injury-information
description: paralyzed veterans of america website
citation: Garber SL, Rintala DH, Hart KA, Fuhrer MJ. Pressure ulcer risk in spinal cord injury: predictors of ulcer status over 3 years. Arch Phys Med Rehabil. 2000 Apr;81(4):465-71. doi: 10.1053/mr.2000.3889.
PMID: 10768537
citation: Gray DB, Hollingsworth HH, Stark SL, Morgan KA. Participation survey/mobility: psychometric properties of a measure of participation for people with mobility impairments and limitations. Arch Phys Med Rehabil. 2006 Feb;87(2):189-97. doi: 10.1016/j.apmr.2005.09.014.
PMID: 16442971
citation: Miller LC, Gottlieb M, Morgan KA, Gray DB. Interviews with employed people with mobility impairments and limitations: environmental supports impacting work acquisition and satisfaction. Work. 2014;48(3):361-72. doi: 10.3233/WOR-131784.
PMID: 24284677
citation: Craig A, Tran Y, Middleton J. Psychological morbidity and spinal cord injury: a systematic review. Spinal Cord. 2009 Feb;47(2):108-14. doi: 10.1038/sc.2008.115. Epub 2008 Sep 9.
PMID: 18779835
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Carla Walker
investigator title: Principal Investigator
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: No
ipd description: No plan to share participant data with other researchers at this time.