Spinal Cord Injury Collaborative Care Study

NCT02026167 | Completed

• 1 other identifier: STUDY00001791
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury

Keywords

Chronic Pain; Mood; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  Quality of Life is assessed via telephone interviews at baseline and 4 months.

  Baseline, 4 months

Secondary Outcomes (5)

• Change in Pain

  Baseline, 4 months, 8 months

• Change in Mood

  Baseline, 4 months, 8 months.

• Change in Physical Activity

  Baseline, 4 months, 8 months

• Change in Quality of Life

  Baseline, 8 months

• Adverse events

  baseline to 4 months

Study Arms (2)

Usual Care

NO INTERVENTION

No intervention, usual care

Intervention

EXPERIMENTAL

Collaborative care with Health Care Assistant

Behavioral: Collaborative Care

Interventions

Collaborative Care BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• psychiatric condition that would interfere with participation
• major surgery in the next 8 months

Sponsors & Collaborators

• University of Washington: lead
• U.S. Department of Education: collaborator

Related Links

• General study information on the Northwest Regional SCI System website

MeSH Terms

Conditions

Spinal Cord Injuries; Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Charles H Bombardier, Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: January 1, 2014
• Study Start: December 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share