Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans
|ClinicalTrials.gov Identifier: NCT00540020|
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : October 5, 2007
Context: Traumatic brain injury (TBI) is a common condition associated with significant long-term cognitive, behavioral, and functional morbidities. There are minimal controlled efficacy data of various acute rehabilitation intervention approaches.
Objective: To determine the relative efficacy of two different acute TBI rehabilitation approaches - cognitive-didactic versus functional-experiential. Secondarily to determine relative efficacy for different patient subpopulations based on baseline cognitive functioning.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Other: Rehabilitation||Not Applicable|
A randomly assigned, intent-to-treat model of two different comprehensive treatment programs conducted between July 19 1996 and May 16, 2003 in 360 adult participants with moderate to severe TBI treated in four participating Veterans Administration TBI rehabilitation centers.
All patients admitted to the Commission for Accreditation of Rehabilitation Facilities (CARF) accredited acute inpatient rehabilitation brain injury programs at 4 participating Veterans Administration Medical Centers (VAMCs) (Minneapolis, Palo Alto, Richmond, and Tampa) during the study enrollment period were screened for eligibility.
The design was a randomized-controlled trial with two treatment arms (cognitive-didactic and functional-experiential), both embedded within an interdisciplinary TBI rehabilitation program. All treatment was hospital based. The interactive nature of the experimental conditions precluded subject blinding. Since each participating site serves a wide geographic area, the protocol permitted post-hospital outcome assessments by structured telephonic interview, to minimize drop out.
Participants completed baseline assessment then received by random assignment one of the two standardized protocol rehabilitation programs (summarized below and described in detail elsewhere). Participants received 1.5 to 2.5 hours daily of protocol-specific therapy plus another 2 to 2.5 hours daily of occupational and physical therapy. Independent teams of therapists functioned at each site to deliver the separate treatments and by necessity were not blinded to treatment. Protocol monitoring site visits, biweekly conference calls, and biannual investigator meetings were conducted to ensure uniformity of protocol treatment over time.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans: DVBIC Randomized Clinical Trial of Two Rehabilitation Approaches|
|Study Start Date :||July 1996|
|Actual Study Completion Date :||May 2003|
Developed by Sohlberg & Mateer to target four cognitive domains often impaired by TBI: attention, memory, executive functions, and pragmatic communication. Subjects practiced progressively more difficult paper-and-pencil or computerized cognitive tasks in 1:1 cognitive therapy sessions (1.5-2.5 hours daily).
The works of Giles and Clark-Wilson and Hartley guided the basic concepts and treatment of the functional-experiential arm (Functional). The objective of the functional protocol was to use real life performance situations and common tasks to remediate or compensate for functional deficits after brain injury. Functional protocol treatment interventions (1.5-2.5 hours daily) typically occurred in group settings and natural environments (hospital recreation areas, group rooms, simulated home environments in the dining room, community outings, etc.).
- (1) Functional independence (i.e., ability to live independently with less than 3 hours of assistance per week) (2) Return to work/school (i.e., paid employment or school enrollment, either full or part time) [ Time Frame: One-year Follow-up ]
- The Functional Independence Measures (FIM)33, 34 consisting of motor and cognitive scores and the Disability Rating Scale Score (DRS)35 were measured. [ Time Frame: Discharge from Protocol Treatment ]
- Quality of life, psychosocial function, behavioral, and mood state measures [ Time Frame: One-year Follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540020
|Principal Investigator:||Deborah L. Warden, M.D.||The Defense and Veterans Brain Injury Center|
|Principal Investigator:||Elaine Date, M.D.||VA Palo Alto Health Care System|
|Principal Investigator:||Steven Scott, D.O.||James A. Haley VA|
|Principal Investigator:||Barbara Sigford, M.D., Ph.D.||Minneapolis VA|
|Principal Investigator:||William Walker, M.D.||Hunter H. McGuire VAMC|