An estimated 180,000 to 360,000 U.S. troops in the Global Wars on Terror have suffered war-related traumatic brain injuries (TBI), representing up to 20 percent. This population has significant unmet needs for nonpharmacological therapies, and a serious gap exists in evidence for the effectiveness of interventions. Through a partnership between Thomas Jefferson University and the Philadelphia VA Medical Center (PVAMC), we propose a two-group parallel randomized controlled trial (RCT) to evaluate the preliminary effectiveness and acceptability of the Veterans'In-home Program (VIP). The goal of this innovative intervention is to enhance community reintegration of veterans with mild to moderate TBI by improving person-environment fit. VIP's specific objects are optimizing physical, cognitive, and emotional/behavioral daily functioning through the introduction of (1) home modifications and adaptation strategies to support physical functioning, (2) compensatory strategies to enhance cognitive functioning, and (3) emotion-regulation strategies to manage behavioral and interpersonal difficulties. Additionally, family caregivers are trained to understand veterans'capabilities, manage limitations, and support their use of intervention strategies. The 8-session 3-month program is delivered by occupational therapists (OTs) in the veteran's home. As a home-based program, VIP complements current clinic-based medical interventions. It is based on psychosocial and environmental approaches previously used successfully with other populations that share important clinical characteristics with TBI patients. VIP targets home environmental modifications in order to create enabling conditions for the individual with TBI, is theory-driven, and combines best clinical practice with previously tested intervention components. To enhance its clinical applicability, it is reproducible and its components are reimbursable under current VA guidelines. The study will enroll 100 veterans with war-related TBI and a designated family member or partner. Veterans will be outpatients of the polytrauma service of the PVAMC. The VIP will be tested using a randomized two-group wait-list design in which participants are assigned to either the 3-month intervention or a usual care control condition. All are evaluated at baseline and 3 months (T2). Primary aims are to (1) establish acceptability and preliminary effectiveness for the impact of the intervention on functioning and community integration in TBI patients at 3-months and (2) evaluate VIP's acceptance by Veterans using both project evaluations and focus group discussion. Secondary aims are to (1) establish VIP's acceptability and preliminary effectiveness on caregiver burden and mood and (2) assess its acceptability to family members using project evaluations and focus groups discussions. This study will result in an innovative home-based treatment approach that can be tested in a larger multi-site randomized controlled trial. The intervention promises to have an immediate major impact by enhancing the abilities of veterans with TBI to reintegrate into their communities and function effectively in daily life and employment.

Public Health Relevance

If proven effective, the Veteran's In-home Program (VIP) will represent the first evidence- based intervention that considers both the patient with mild-moderate traumatic brain injury (TBI) and family. This study is an important step towards filling a critical gap in services for individuals with mild-moderate TBI. Because VIP is designed to augment and extend current clinical care, it would substantially add to the clinical tools available for war- related TBI and also has the potential to benefit the 1.4 million U.S. civilians who annually sustain TBI.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21HD068857-02
Application #
8299504
Study Section
Motor Function, Speech and Rehabilitation Study Section (MFSR)
Program Officer
Quatrano, Louis A
Project Start
2011-08-01
Project End
2014-07-31
Budget Start
2012-08-01
Budget End
2014-07-31
Support Year
2
Fiscal Year
2012
Total Cost
$199,507
Indirect Cost
$27,900
Name
Philadelphia Research and Edu Foundation
Department
Type
DUNS #
143624497
City
Philadelphia
State
PA
Country
United States
Zip Code
19104