SCI-CARE (Northwest Regional Spinal Cord Injury Site Specific Project)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 174
- Primary Endpoint
- Change in Quality of Life
Study Overview
Brief Summary
The objective of this study is to test the effectiveness of a collaborative care approach to improving outpatient treatment for inactivity, chronic pain and depression as a way of improving overall Quality of Life for patients with SCI.
Detailed Description
Individuals with SCI were treated by a care manager who worked in collaboration with the participant's physician to decrease pain, decrease depression symptoms, and/or to increase physical activity. This was done by collaborating on current treatments to make sure that they are being as effective as possible and by providing non-pharmacological treatments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •diagnosis of traumatic spinal cord injury by medical record review
- •receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic
- •positive screening for pain related to SCI diagnosis and/or
- •positive screening for low mood and/or
- •negative screening for physical activity levels
- •able to speak and understand English
Exclusion Criteria
- •psychiatric condition that would interfere with participation
- •major surgery in the next 8 months
Arms & Interventions
Usual Care
No intervention, usual care
Intervention
Collaborative care with Health Care Assistant
Intervention: Collaborative Care (Behavioral)
Outcomes
Primary Outcomes
Change in Quality of Life
Time Frame: Baseline, 4 months
Quality of Life is assessed via telephone interviews at baseline and 4 months.
Secondary Outcomes
- Change in Physical Activity(Baseline, 4 months, 8 months)
- Change in Mood(Baseline, 4 months, 8 months.)
- Change in Quality of Life(Baseline, 8 months)
- Adverse events(baseline to 4 months)
- Change in Pain(Baseline, 4 months, 8 months)
Investigators
Charles Bombardier
Professor, Rehabilitation Medicine
University of Washington