Spinal Cord Injury Collaborative Care Study | NCT02026167

Studies
Spinal Cord Injury Collaborative Care Study

NCT02026167

Sponsor

University of Washington

Status

Completed

Last Update Posted

Feb 26, 2019Actual

Enrollment

174Actual

Phase

Not Applicable

Conditions

Spinal Cord Injury

Interventions

Collaborative Care

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Dec 26, 2013

First Submission Date that Met QC Criteria

Dec 30, 2013

First Posted Date

Jan 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2019

Last Update Posted Date

Feb 26, 2019Actual

Name	Class
U.S. Department of Education	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

174Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Care	No Intervention	No intervention, usual care
Intervention	Experimental	Collaborative care with Health Care Assistant	Behavioral: Collaborative Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collaborative Care	Behavioral	Addition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Quality of Life	Quality of Life is assessed via telephone interviews at baseline and 4 months.	Baseline, 4 months

Secondary Outcomes

Measure	Description	Time Frame
Change in Pain	Pain is assessed via telephone interview at baseline, 4 months, and 8 months.	Baseline, 4 months, 8 months
Change in Mood	Mood assessed via telephone interviews at baseline, 4 months, and 8 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles H Bombardier, Ph.D.	University of Washington	Principal Investigator

Locations

Not provided

References Module

Citations

Not provided

ID	Term
D013119	Spinal Cord Injuries
D059350	Chronic Pain
D009043	Motor Activity

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System