Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS (COMPASS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01816061|
Recruitment Status : Active, not recruiting
First Posted : March 21, 2013
Last Update Posted : October 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Post-Traumatic Stress Disorder||Behavioral: Experimental - COMPASS Behavioral: Control - COMPASS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS|
|Actual Study Start Date :||March 12, 2014|
|Actual Primary Completion Date :||March 6, 2017|
|Estimated Study Completion Date :||March 31, 2018|
Experimental: Arm 1: Experimental
The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.
Behavioral: Experimental - COMPASS
Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.
Active Comparator: Arm 1: Control
Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.
Behavioral: Control - COMPASS
Increased hours of patient-provider interactions Group.
Other Name: Supported discharge group
- Change from Baseline in Community Reintegration for Injured Service Members at 2 months [ Time Frame: 2 months ]Measured through Community Reintegration for Injured Service Members (CRIS)
- Change from Baseline in Frontal Systems Behavior Scale at 2 months [ Time Frame: 2 months ]Measured through Frontal Systems Behavior Scale (FrSBe)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816061
|United States, District of Columbia|
|Washington DC VA Medical Center, Washington, DC|
|Washington, D.C., District of Columbia, United States, 20422|
|Principal Investigator:||Alexander V Libin, PhD||Washington DC VA Medical Center, Washington, DC|