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Primary registry and trial identifying number
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ClinicalTrials.gov NCT01816061
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Date of registration in primary registry
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March 19, 2013
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Secondary identifying numbers
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I01RX000637-01A3 D0637-R
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Source(s) of monetary or material support
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United States Department of Veterans Affairs Rehabilitation Research and Development Service
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Primary sponsor
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United States Department of Veterans Affairs Rehabilitation Research and Development Service
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Contact for public queries
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AVL [Alexander.Libin2@va.gov], ED [Ellen.Danford@va.gov]
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Contact for scientific queries
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AVL [Alexander.Libin2@va.gov]
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Public title
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Executive Functioning in TBI from Rehabilitation to Social Reintegration: COMPASS
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Scientific title
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Executive Functioning in TBI from Rehabilitation to Social Reintegration: COMPASS
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Countries of recruitment
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United States of America
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Health condition(s) or problem(s) studied
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TBI
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Intervention(s)
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Experimental—Fifty-five participants in the intervention group will receive eight goal self-management sessions. Control—Increased hours of patient-provider interactions.
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Key inclusion and exclusion criteria
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Ages eligible for study: 18–55 Sexes eligible for study: Both Accepts healthy volunteers: Yes Inclusion and Exclusion Criteria: See Table 2.
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Study type
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Interventional Allocation: Randomized Intervention Model: Parallel assignment Masking: Single blind (outcome accessor) Primary Purpose: Treatment Phase 0
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Date of first enrollment
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December 2014
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Target sample size
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110
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Recruitment status
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Recruiting
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Primary outcome(s)
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Change in Baseline in CRIS assessment at 2 months and 5 months. Change in Baseline in FrSBe assessment at 2 months and 5 months.
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Key secondary outcomes
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N/A
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