Clinical trial NCT04457206: Effectiveness of the Collaborative Community Clinic for Persons With Spinal Cord Injury and Disease
Official title: Evaluating the Effectiveness of the Collaborative Community Clinic for Persons With Spinal Cord Injury and Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injuries
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: General Self-Efficacy Scale
timeFrame: pre-assessment before participation in the CCC and post-assessment following completion (approximately 12 weeks)
measure: The Canadian Occupational Performance Measure (COPM)
timeFrame: pre-assessment before participation in the CCC and post-assessment upon completion of CCC participation (approximately 12 weeks)
Secondary outcomes:
measure: Promis 29 Global Health Measure
timeFrame: pre-assessment prior to participation in the CCC and post-assessment upone completion of CCC participation (approximately 12 weeks)
measure: Community Participation Index (CPI):
timeFrame: pre-assessment prior to participation in the CCC and post-assessment upon completion of the CCC participation (approximately 12 weeks)
measure: PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a
timeFrame: pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks)
measure: Promis Item Bank v1.0 - Applied Cognition-Abilities Short Form 8a
timeFrame: pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University Program in Occupational Therapy
name: Carla W Walker, OTD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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.