- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04457206
Effectiveness of the Collaborative Community Clinic for Persons With Spinal Cord Injury and Disease (SCI/D)
May 18, 2023 updated by: Carla Walker, Washington University School of Medicine
Evaluating the Effectiveness of the Collaborative Community Clinic for Persons With Spinal Cord Injury and Disease
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carla W Walker, OTD
- Phone Number: 3142737011
- Email: walkerc@wustl.edu
Study Contact Backup
- Name: Sue Tucker, OTD
- Phone Number: 314273-7008
- Email: tuckers@wustl.edu
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University
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Contact:
- Carla W Walker, OTD
- Phone Number: 314-273-7011
- Email: walkerc@wustl.edu
-
Contact:
- Sue Tucker, OTD
- Phone Number: 3142737008
- Email: tuckers@wustl.edu
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Principal Investigator:
- Carla W Walker, OTD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Persons participating in the Collaborative Community Clinic are 18 years of age or older, have the diagnosis of spinal cord injury or disease and are un-insured or under-insured for occupational therapy services.
For example, they may have Medicaid coverage, but no therapy visits allowed.
Or, they may be waiting on Medicare eligibility to kick in following injury, which usually takes approximately two years.
Persons may be referred following discharge from the local rehabilitation center, be referred from other community agencies, or self-referred.
Description
Inclusion Criteria:
- 18 years of age; diagnosis of spinal cord injury or disease, un-insured or under-insured for occupational therapy services
Exclusion Criteria:
- under 18 years of age, lack of SCI/D diagnosis, full insurance coverage for OT services (ie. Medicare or Private Insurance)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Self-Efficacy Scale
Time Frame: pre-assessment before participation in the CCC and post-assessment following completion (approximately 12 weeks)
|
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).
|
pre-assessment before participation in the CCC and post-assessment following completion (approximately 12 weeks)
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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)
|
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.
|
pre-assessment before participation in the CCC and post-assessment upon completion of CCC participation (approximately 12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
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pre-assessment prior to participation in the CCC and post-assessment upone completion of CCC participation (approximately 12 weeks)
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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)
|
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)
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pre-assessment prior to participation in the CCC and post-assessment upon completion of the CCC participation (approximately 12 weeks)
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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)
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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.
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pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks)
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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)
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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.
|
pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carla W Walker, OTD, Washington University Program in Occupational Therapy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2020
Primary Completion (Anticipated)
January 29, 2025
Study Completion (Anticipated)
January 29, 2025
Study Registration Dates
First Submitted
June 24, 2020
First Submitted That Met QC Criteria
June 29, 2020
First Posted (Actual)
July 7, 2020
Study Record Updates
Last Update Posted (Actual)
May 19, 2023
Last Update Submitted That Met QC Criteria
May 18, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202001182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share participant data with other researchers at this time.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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