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Table 1 Trial registration data set

From: Executive functioning in TBI from rehabilitation to social reintegration: COMPASS goal, a randomized controlled trial (grant: 1I01RX000637-01A3 by the VA ORD RR&D, 2013–2016)

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