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Completed

NCT Number: NCT02026167

Spinal Cord Injury Collaborative Care Study

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.

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Key information

Conditions

Spinal Cord Injury Behavior Central Nervous System Diseases Chronic Pain Motor Activity Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collaborative care

Behavioral

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

Primary outcomes

  1. Change in Quality of Life

    Time frame: Baseline, 4 months

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

Secondary outcomes

  1. Change in Pain

    Time frame: Baseline, 4 months, 8 months

    Pain is assessed via telephone interview at baseline, 4 months, and 8 months.

  2. Change in Mood

    Time frame: Baseline, 4 months, 8 months.

    Mood assessed via telephone interviews at baseline, 4 months, and 8 months.

  3. 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.

  4. Change in Quality of Life

    Time frame: Baseline, 8 months

    Change in QOL from baseline to 8 months will be compared between groups

  5. Adverse events

    Time frame: baseline to 4 months

    The number of cases with serious or non-serious adverse events in the two arms

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

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

Acronym: SCI-Care

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2014
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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