Spinal Cord Injury Collaborative Care Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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SCI-CARE (Northwest Regional Spinal Cord Injury Site Specific Project)

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Behavioral: Collaborative Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>No intervention, usual care | |
| Experimental: Intervention<br>Collaborative care with Health Care Assistant | Behavioral: Collaborative Care<br>* Addition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Quality of Life is assessed via telephone interviews at baseline and 4 months. | Baseline, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Pain is assessed via telephone interview at baseline, 4 months, and 8 months. | Baseline, 4 months, 8 months | 
| Change in Mood | Mood assessed via telephone interviews at baseline, 4 months, and 8 months. | Baseline, 4 months, 8 months. | 
| Change in Physical Activity | Physical activity is assess via telephone interview at baseline, 4 months, and 8 months. | Baseline, 4 months, 8 months | 
| Change in Quality of Life | Change in QOL from baseline to 8 months will be compared between groups | Baseline, 8 months | 
| Adverse events | The number of cases with serious or non-serious adverse events in the two arms | baseline to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Mood, Physical Activity