Effectiveness of the Collaborative Community Clinic for Persons With Spinal Cord Injury and Disease

NCT04457206 | Recruiting DMC

• 1 other identifier: 202001182
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• Promis 29 Global Health Measure

  pre-assessment prior to participation in the CCC and post-assessment upone completion of CCC participation (approximately 12 weeks)

• Community Participation Index (CPI):

  pre-assessment prior to participation in the CCC and post-assessment upon completion of the CCC participation (approximately 12 weeks)

• PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a

  pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks)

• Promis Item Bank v1.0 - Applied Cognition-Abilities Short Form 8a

  pre-assessment prior to participation in the CCC and post-assessment upon completion of participation in the CCC (approximately 12 weeks)

Interventions

SCI Group and one-on-one services through student led occupational therapy clinic BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years of age; diagnosis of spinal cord injury or disease, un-insured or under-insured for occupational therapy services

You may not qualify if:

• under 18 years of age, lack of SCI/D diagnosis, full insurance coverage for OT services (ie. Medicare or Private Insurance)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

Related Links

• paralyzed veterans of america website

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Carla W Walker, OTD

  Washington University Program in Occupational Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla W Walker, OTD

CONTACT

3142737011; walkerc@wustl.edu

Sue Tucker, OTD

CONTACT

314273-7008; tuckers@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 7, 2020
• Study Start: January 29, 2020
• Primary Completion (Estimated): January 29, 2030
• Study Completion (Estimated): January 29, 2030
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)