Evaluation of the Veterans' In-home Program (VIP)

June 22, 2015 updated by: Laraine Winter, Corporal Michael J. Crescenz VA Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient with mild-moderate TBI followed by PVAMC Polytrauma Service
  • English speaking
  • a family member/partner living with or nearby who is willing to participate in the study

Exclusion Criteria:

  • At high risk for violence
  • currently receiving in-home service

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control condition
The control group receives two attention-control calls.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary effectiveness and acceptability for Veteran
Time Frame: 4 months
Preliminary effectiveness includes Veterans' physical, cognitive, and emotional/interpersonal functioning and community reintegration. Acceptability is measured through project evaluations and qualitative interviews.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary effectiveness and acceptability for family member
Time Frame: 4 months
Preliminary effectiveness is measured through mood and dimensions of well-being. Acceptability is measured through project evaluations and qualitative interviews.
4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refinement of intervention procedures and assessment tools
Time Frame: 4 months
The Delivery Assessments describe characteristics of the intervention.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporal Michael J. Crescenz VA Medical Center

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Laraine Winter, PhD, Philadelphia VA Medical Center, The Philadelphia Research & Education Foundation
  • Principal Investigator: Helene J Moriarty, PhD, RN, Corporal Michael J. Crescenz VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 11, 2013

First Submitted That Met QC Criteria

April 12, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01308
  • 1R21HD068857-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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