An interventional study of Experimental - COMPASS and Control - COMPASS in Traumatic Brain Injury and Post-Traumatic Stress Disorder, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD
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. The COMPASSgoal intervention will be developed and implemented to meet these needs. COMPASSgoal will integrate principles and best practices of goal self-management. Goal setting is a core skill in self-management training by which persons with chronic health conditions learn to improve their status and decrease symptom impact.3F One important mechanism of action of this program appears to be its positive effect on self-efficacy, or confidence in one's ability to attain goals and solve problems.4F
The study goal is to gather data on the efficacy of a novel approach to psychosocial rehabilitation for Veterans with executive function impairment due to traumatic brain injury (TBI), and to explore over time, through relevant measures, Veteran responsiveness to intervention. Veterans with mild TBI will be randomized into two groups: the COMPASS (Community Participation through Self-Efficacy Skills Development) goal-management intervention group and the supported discharge group.
110 participants with residual deficits in executive function due to TBI will be recruited at a minimum of 3 months post-injury from the TBI program at the DC VAMC over the three-year period of the study. The operational definition of executive dysfunction/ inclusion into the study is based on both clinical diagnosis by a study physician and a standardized executive dysfunction measure, the Frontal Systems Rating Scale (FrSBe score), such that a total score or any of the 3 subscale scores \< 1 SD compared to the normative score would indicate executive dysfunction sufficient to include in the study. The treatment phase for the Veterans enrolled in the intervention group will continue for two consecutive months (8 weekly sessions).
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's enrollment of 91 is above the median of 55 across 1,158 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →VA Office of Research and Development is the lead sponsor of 1,767 studies on the registry; 394 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 183 (88%) have results posted.
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Exclusion Criteria:
Severe multiple trauma (as judged by the attending physicians and/or investigators that is too severe to participate in this study) such as:
Goal-setting sessions
Behavioral: Experimental - COMPASS
Informative phone calls
Behavioral: Control - 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.
Increased hours of patient-provider interactions Group.
Also known as: Supported discharge group
Change From Baseline in Community Reintegration for Injured Service Members at 2 Months
Change from Baseline in Community Reintegration for Injured Service Members (CRIS) at 2 months. The investigators used in the report CRIS subscale - Extent of Participation, CRIS with the score range 28.0-64.0. Higher scores mean a better outcome for the Extent of Participation, Community Reintegration for Injured Service Members (CRIS)
Time frame: Baseline and 2 months
Change From Baseline in Frontal Systems Behavior Scale at 2 Months
Change from Baseline in Frontal Systems Behavior Scale (FrSBe) at 2 months. Minimum value =21, Maximum value=158, Higher score correlates with worse outcome.
Time frame: Baseline and 2 months
| Milestone | Arm 1: Experimental | Arm 1: Control |
|---|---|---|
| Started | 40 | 51 |
| Completed | 27 | 27 |
| Not completed | 13 | 24 |
| Withdrew: Lost to follow-up | 13 | 24 |
Change from Baseline in Community Reintegration for Injured Service Members (CRIS) at 2 months. The investigators used in the report CRIS subscale - Extent of Participation, CRIS with the score range 28.0-64.0. Higher scores mean a better outcome for the Extent of Participation, Community Reintegration for Injured Service Members (CRIS)
| score on a scale | Arm 1: Experimental | Arm 1: Control |
|---|---|---|
| Change From Baseline in Community Reintegration for Injured Service Members at 2 Months | 40.22 ± 5.56 | 37.79 ± 6.04 |
Change from Baseline in Frontal Systems Behavior Scale (FrSBe) at 2 months. Minimum value =21, Maximum value=158, Higher score correlates with worse outcome.
| score on a scale | Arm 1: Experimental | Arm 1: Control |
|---|---|---|
| Change From Baseline in Frontal Systems Behavior Scale at 2 Months | 85.4 ± 12.2 | 84.3 ± 13.12 |
Collected over 4 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Experimental | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Arm 1: Control | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Categorical(Participants) | Experimental - COMPASS | Control - COMMPASS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 27 | 54 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Experimental - COMPASS | Control - COMMPASS | Total |
|---|---|---|---|
| Mean | 39.7 ± 8.3 | 39.6 ± 6.9 | 39.7 ± 7.6 |
| Sex: Female, Male(Participants) | Experimental - COMPASS | Control - COMMPASS | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 22 | 23 | 45 |
| Race (NIH/OMB)(Participants) | Experimental - COMPASS | Control - COMMPASS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 27 | 27 | 54 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Experimental - COMPASS | Control - COMMPASS | Total |
|---|---|---|---|
| United States | 27 | 27 | 54 |
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