Spinal Cord Injury Collaborative Care Study (SCI-Care)

February 23, 2019 updated by: Charles Bombardier, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

U.S. Department of Education

Investigators

  • Principal Investigator: Charles H Bombardier, Ph.D., University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

December 26, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (ESTIMATE)

January 1, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 23, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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