Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
172 participants
INTERVENTIONAL
2011-10-31
2014-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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control condition
The control group receives two attention-control calls.
No interventions assigned to this group
The Veterans' in-home program
The VIP intervention consists of 8 sessions (up to 6 in the home and 2 phone calls) from an occupational therapist. This is delivered to Veterans and their family members.
The Veterans' In-home Program
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.
Interventions
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The Veterans' In-home Program
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.
Eligibility Criteria
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Inclusion Criteria
* English speaking
* a family member/partner living with or nearby who is willing to participate in the study
Exclusion Criteria
* currently receiving in-home service
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Corporal Michael J. Crescenz VA Medical Center
FED
Responsible Party
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Laraine Winter
Research Psychologist
Principal Investigators
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Laraine Winter, PhD
Role: PRINCIPAL_INVESTIGATOR
Philadelphia VA Medical Center, The Philadelphia Research & Education Foundation
Helene J Moriarty, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Corporal Michael J. Crescenz VA Medical Center
Locations
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Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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01308
Identifier Type: -
Identifier Source: org_study_id
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