Table 1 Trial registration data set
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 |