The HOME Program for Individuals With Traumatic Brain Injury and Family Members

Summary

This purpose of this study is to evaluate an innovative rehabilitation intervention for persons with chronic TBI-related symptoms (1 year or more post injury) and their families. The primary study aims are to 1) test the intervention's effects on patients' community reintegration, quality of life, and ability to manage self-identified TBI problems at the completion of the intervention and 2) test the intervention's effects on family caregivers' depressive symptoms, burden, and met family needs at the completion of the intervention.

Based on the person-environment fit framework, HOME (Home-based Occupational-therapy and Management of the Environment) for Us is a 4-month, 8-session intervention delivered by occupational therapists in the home. HOME targets the home environment (physical and social) to realign environmental demands to individual strengths and deficits. HOME engages persons with TBI and family caregivers in strategies to manage chronic TBI symptoms or related difficulties. It educates family members to reinforce and maintain intervention strategies, and addresses family needs. HOME is distinct from standard TBI rehabilitation with respect to who (persons with TBI and families), what (targeting the environment for intervention), when (chronic phase), and where (the home).

Patients with chronic TBI symptoms and their family caregivers represent a growing but underserved population. This study has the potential to benefit over 5.3 million persons who live with disabilities from TBI and their family caregivers and to transform the paradigm of care for TBI.

Conditions

• Brain Injuries, Traumatic

Interventions

BEHAVIORAL

HOME for Us

HOME is an in-home, family inclusive, rehabilitation intervention in 8 sessions. Six of the sessions will be in-home and 2 will be over the phone. The in-home sessions will be about 1 ½ hrs. each, and the phone sessions will be about 15 minutes each. The sessions are delivered by an occupational therapist (OT).

BEHAVIORAL

Attention-control condition

The Attention-control condition consists of educational materials presented over 8 contacts. Two of the contacts are by video conferences or phone calls and last 1 to 2 hours each. Two of the contacts are mailings of educational materials for discussion during the longer sessions. Three of the contacts are phone calls lasting about 10-15 minutes each to check for general updates, health care utilization/access, and study reminders.

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• Drexel University

  collaborator OTHER

• Louisiana State University Health Sciences Center - New Orleans

  collaborator UNKNOWN

• Villanova University

  lead OTHER

Principal Investigators

• Helene Moriarty, PhD, RN, FAAN · Villanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.

• Laraine Winter, PhD · Villanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-22

Primary Completion

2025-11-30

Completion

2026-05-30

Countries

• United States

Study Locations