Spinal Cord Injury
Conditions
Keywords
Chronic Pain, Mood, Physical Activity
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.
Interventions
BEHAVIORALCollaborative Care
Addition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions
Sponsors
U.S. Department of Education
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | Baseline, 4 months | Quality of Life is assessed via telephone interviews at baseline and 4 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | Baseline, 4 months, 8 months | Pain is assessed via telephone interview at baseline, 4 months, and 8 months. |
| Change in Mood | Baseline, 4 months, 8 months. | Mood assessed via telephone interviews at baseline, 4 months, and 8 months. |
| Change in Physical Activity | Baseline, 4 months, 8 months | Physical activity is assess via telephone interview at baseline, 4 months, and 8 months. |
| Change in Quality of Life | Baseline, 8 months | Change in QOL from baseline to 8 months will be compared between groups |
| Adverse events | baseline to 4 months | The number of cases with serious or non-serious adverse events in the two arms |
Outcome results
None listed