Spinal Cord Injury Collaborative Care Study

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Behavioral: Collaborative Care

• Registration Number: NCT02026167
• Lead Sponsor: University of Washington

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-12-26
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2014-01-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-23
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Collaborative Care	Collaborative care with Health Care Assistant

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life	Baseline, 4 months	Quality of Life is assessed via telephone interviews at baseline and 4 months.

Secondary Outcome Measures

Name	Time	Method
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 Mood	Baseline, 4 months, 8 months.	Mood assessed via telephone interviews 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
Change in Pain	Baseline, 4 months, 8 months	Pain is assessed via telephone interview at baseline, 4 months, and 8 months.