Spinal Cord Injury Collaborative Care Study

Spinal Cord Injury Clinical Trial

— SCI-Care  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026167
• Other study ID #: STUDY00001791
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: June 2016

Study information

• Verified date: February 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Behavioral:
• Collaborative Care
Addition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	U.S. Department of Education

Outcome

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

External Links

•   General study information on the Northwest Regional SCI System website