Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans

Sponsor

The Defense and Veterans Brain Injury Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00540020

Collaborator

James A. Haley Veterans Administration Hospital (U.S. Fed), Hunter Holmes Mcguire Veteran Affairs Medical Center (U.S. Fed), Minneapolis Veterans Affairs Medical Center (U.S. Fed), VA Palo Alto Health Care System (U.S. Fed), US Department of Veterans Affairs (U.S. Fed)

360

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

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 :

Jul 1, 1996

Actual Study Completion Date :

May 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive-Didactic 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).	Other: Rehabilitation
Experimental: Functional-Experiential 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.).	Other: Rehabilitation

Arm

Intervention/Treatment

Experimental: Cognitive-Didactic

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).

Other: Rehabilitation

Experimental: Functional-Experiential

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.).

Other: Rehabilitation

Outcome Measures

Primary Outcome Measures

(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) [One-year Follow-up]

Secondary Outcome Measures

The Functional Independence Measures (FIM)33, 34 consisting of motor and cognitive scores and the Disability Rating Scale Score (DRS)35 were measured. [Discharge from Protocol Treatment]
Quality of life, psychosocial function, behavioral, and mood state measures [One-year Follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

moderate-to-severe closed head injury, manifested by a post-resuscitation Glasgow Coma Scale (GCS) score of 12 or less, or coma of 12 hours or more , or posttraumatic amnesia (PTA) of 24 hours or more, and/or focal cerebral contusion or hemorrhage on computed tomography (CT) or magnetic resonance imaging (MRI)
documented traumatic brain injury within 6 months of randomization
Rancho Los Amigos Scale (RLAS) cognitive level of 5-7 at time of randomization
age 18 or older
active duty military member or veteran
anticipated length of needed acute interdisciplinary TBI rehabilitation of 30 days or more

Exclusion Criteria:

history of prior moderate to severe traumatic brain injury or other pre-injury severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Defense and Veterans Brain Injury Center
James A. Haley Veterans Administration Hospital
Hunter Holmes Mcguire Veteran Affairs Medical Center
Minneapolis Veterans Affairs Medical Center
VA Palo Alto Health Care System
US Department of Veterans Affairs

Investigators

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