Trial Outcomes & Findings for Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS (NCT NCT01816061)
NCT ID: NCT01816061
Last Updated: 2019-09-25
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
Baseline and 2 months
Results posted on
2019-09-25
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
Control
Control - COMPASS: Increased hours of patient-provider interactions Group.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
51
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
13
|
24
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
Control
Control - COMPASS: Increased hours of patient-provider interactions Group.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
24
|
Baseline Characteristics
Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
Baseline characteristics by cohort
| Measure |
Experimental - COMPASS
n=27 Participants
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.
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.
|
Control - COMMPASS
n=27 Participants
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.
Control
Control - COMPASS: Increased hours of patient-provider interactions Group.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 8.3 • n=93 Participants
|
39.6 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
39.7 years
STANDARD_DEVIATION 7.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 monthsChange 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)
Outcome measures
| Measure |
Arm 1: Experimental
n=27 Participants
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.
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.
|
Arm 1: Control
n=27 Participants
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.
Control
Control - COMPASS: Increased hours of patient-provider interactions Group.
|
|---|---|---|
|
Change From Baseline in Community Reintegration for Injured Service Members at 2 Months
|
40.22 score on a scale
Standard Deviation 5.56
|
37.79 score on a scale
Standard Deviation 6.04
|
PRIMARY outcome
Timeframe: Baseline and 2 monthsChange from Baseline in Frontal Systems Behavior Scale (FrSBe) at 2 months. Minimum value =21, Maximum value=158, Higher score correlates with worse outcome.
Outcome measures
| Measure |
Arm 1: Experimental
n=27 Participants
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.
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.
|
Arm 1: Control
n=27 Participants
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.
Control
Control - COMPASS: Increased hours of patient-provider interactions Group.
|
|---|---|---|
|
Change From Baseline in Frontal Systems Behavior Scale at 2 Months
|
85.4 score on a scale
Standard Deviation 12.2
|
84.3 score on a scale
Standard Deviation 13.12
|
Adverse Events
Arm 1: Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 1: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place