Traumatic Brain Injury Clinical Trial
Official title:
Evaluation of the Veterans' In-home Programs for Veterans With TBI and Families
The primary objective of this study is to evaluate the preliminary effectiveness and acceptability of an innovative in-home nonpharmacological intervention, the Veterans' In-home Program (VIP), for Veterans with mild to moderate traumatic brain injury (TBI) and their families. VIP is designed to promote community reintegration, improve quality of life, and support functioning by realigning environmental demands to match the Veteran's abilities.
Research Design: Using a 2-group randomized control trial, the investigators will evaluate
the intervention in comparison to usual care. Usual care is traditional clinic-based care,
which will be enhanced by 2 phone calls to provide an attention control condition.
Methodology: Participants will be 100 Veterans diagnosed with mild to moderate TBI who are
followed by the Philadelphia VA Medical Center (PVAMC) Polytrauma Service and a family
member (100) of each Veteran. All Veterans will have a family member or partner living with
them who is willing to participate in the study. The intervention and study interviews will
occur in Veterans' homes. Qualitative phone interviews with a subset of the sample who
received the intervention will be conducted at PVAMC.
Primary study outcomes for the Veterans will be physical, cognitive, and
emotional/interpersonal functioning and community reintegration, measured by standardized
instruments at baseline and follow-up at 3 to 4 months. Study outcomes for family members
will be mood and dimensions of well-being, measured by standardized instruments at baseline
and follow-up at 3 to 4 months. Acceptability of the intervention for Veterans and family
members will be measured through Project Evaluations, administered at follow-up with both
groups. In addition, qualitative phone interviews will be conducted with a subset of
Veterans and family members who received VIP to evaluate VIP's acceptability and to enhance
understanding of the impact of VIP from the perspective of those experiencing it.
Based on a person-environment fit framework, the VIP intervention consists of 8 sessions (up
to 6 in the home and 2 telephone contacts) delivered by occupational therapists over a 3
month period to Veterans and family members. VIP realigns environmental demands to match
Veterans' abilities through the modification of home environments, development of meaningful
activities tailored to Veterans' strengths, training in the use of emotion-regulation
strategies to address behavioral/interpersonal difficulties, and training in the use of
cognitive strategies to compensate for cognitive impairments. In its family focus, VIP
provides family members with education and training to understand and manage the Veterans'
limitations.
Clinical relationships: VIP extends and adds value to traditional on-site clinical care by
helping individuals with TBI and their families in the setting where most functional and
behavioral problems emerge. As a skills-building intervention, VIP has the potential to
enhance Veterans' abilities to function effectively in their home environments and to
improve their quality of life and that of their families.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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