Evaluation of the Veterans' In-home Program

NCT01831830 | Completed

• 2 other identifiers: 013081R21HD068857-01
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; occupational therapy; family

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (1)

• Preliminary effectiveness and acceptability for family member

  4 months

Other Outcomes (1)

• Refinement of intervention procedures and assessment tools

  4 months

Study Arms (2)

control condition

NO INTERVENTION

The control group receives two attention-control calls.

The Veterans' in-home program

EXPERIMENTAL

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

Interventions

The Veterans' In-home Program BEHAVIORAL

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.

The Veterans' in-home program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Corporal Michael J. Crescenz VA Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 15, 2013
• Study Start: October 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

US (1)