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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Veterans' In-home Program
Sponsored by
Corporal Michael J. Crescenz VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, occupational therapy, family

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Philadelphia VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control condition

The Veterans' in-home program

Arm Description

The control group receives two attention-control calls.

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.

Outcomes

Primary Outcome Measures

Preliminary effectiveness and acceptability for Veteran
Preliminary effectiveness includes Veterans' physical, cognitive, and emotional/interpersonal functioning and community reintegration. Acceptability is measured through project evaluations and qualitative interviews.

Secondary Outcome Measures

Preliminary effectiveness and acceptability for family member
Preliminary effectiveness is measured through mood and dimensions of well-being. Acceptability is measured through project evaluations and qualitative interviews.

Full Information

First Posted
April 11, 2013
Last Updated
June 22, 2015
Sponsor
Corporal Michael J. Crescenz VA Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01831830
Brief Title
Evaluation of the Veterans' In-home Program
Acronym
VIP
Official Title
Evaluation of the Veterans' In-home Programs for Veterans With TBI and Families
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporal Michael J. Crescenz VA Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, occupational therapy, family

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control condition
Arm Type
No Intervention
Arm Description
The control group receives two attention-control calls.
Arm Title
The Veterans' in-home program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Veterans' In-home Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preliminary effectiveness and acceptability for Veteran
Description
Preliminary effectiveness includes Veterans' physical, cognitive, and emotional/interpersonal functioning and community reintegration. Acceptability is measured through project evaluations and qualitative interviews.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Preliminary effectiveness and acceptability for family member
Description
Preliminary effectiveness is measured through mood and dimensions of well-being. Acceptability is measured through project evaluations and qualitative interviews.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Refinement of intervention procedures and assessment tools
Description
The Delivery Assessments describe characteristics of the intervention.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laraine Winter, PhD
Organizational Affiliation
Philadelphia VA Medical Center, The Philadelphia Research & Education Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helene J Moriarty, PhD, RN
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Veterans' In-home Program

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