Spinal Cord Injuries Clinical Trial
— SCI/DOfficial title:
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 29, 2030 |
Est. primary completion date | January 29, 2030 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | General Self-Efficacy Scale | 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) | |
Primary | The Canadian Occupational Performance Measure (COPM) | 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 | Promis 29 Global Health Measure | 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. | pre-assessment prior to participation in the CCC and post-assessment upone completion of CCC participation (approximately 12 weeks) | |
Secondary | Community Participation Index (CPI): | 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) | pre-assessment prior to participation in the CCC and post-assessment upon completion of the CCC participation (approximately 12 weeks) | |
Secondary | PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a | 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. | pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks) | |
Secondary | Promis Item Bank v1.0 - Applied Cognition-Abilities Short Form 8a | 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) |
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