Overview

This trial is active, not recruiting.

Condition spinal cord injury
Treatment collaborative care
Sponsor University of Washington
Collaborator U.S. Department of Education
Start date December 2012
End date June 2016
Trial size 200 participants
Trial identifier NCT02026167, 43302-K

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
No intervention, usual care
(Experimental)
Collaborative care with Health Care Assistant
collaborative care
Addition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions

Primary Outcomes

Measure
Change in Quality of Life
time frame: Baseline, 4 months

Secondary Outcomes

Measure
Change in Pain
time frame: Baseline, 4 months, 8 months
Change in Mood
time frame: Baseline, 4 months, 8 months.
Change in Physical Activity
time frame: Baseline, 4 months, 8 months
Change in Quality of Life
time frame: Baseline, 8 months
Adverse events
time frame: baseline to 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title SCI-CARE (Northwest Regional Spinal Cord Injury Site Specific Project)
Principal investigator Charles H Bombardier, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Washington.