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

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ClinicalTrials.gov Identifier: NCT01831830
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : June 24, 2015
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Laraine Winter, Philadelphia Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: The Veterans' In-home Program Not Applicable

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  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Veterans' In-home Programs for Veterans With TBI and Families
Study Start Date : October 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Refinement of intervention procedures and assessment tools [ Time Frame: 4 months ]
    The Delivery Assessments describe characteristics of the intervention.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831830


Locations
United States, Pennsylvania
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Corporal Michael J. Crescenz VA Medical Center
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

Responsible Party: Laraine Winter, Research Psychologist, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01831830     History of Changes
Other Study ID Numbers: 01308
1R21HD068857-01 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Laraine Winter, Philadelphia Veterans Affairs Medical Center:
traumatic brain injury
occupational therapy
family

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries