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

NCT05117619 | Recruiting DMC

• 1 other identifier: IRB-FY2021-60
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Veterans; Family Caregiving; Rehabilitation; Quality of Life; Community Integration

Outcome Measures

Primary Outcomes (6)

• Community reintegration (CR) scores on PART-O-17 for the person with TBI

  Community reintegration will be measured by the Participation Assessment with Recombined Tools-Objective (PART-O-17). This 17-item tool is an objective measure of social functioning, developed from 3 existing community reintegration measures. It uses 6-point Likert scales from 0 to 5. A mean score is computed. Higher scores indicate greater community reintegration. It will be administered at the Baseline interview (T1), Month 4 interview (T2), and Month 10 interview (T3).

  four months and ten months

• Quality of life in TBI scores on the QoL-TBI instrument for the person with TBI

  Quality of life in TBI will be measured by The QoL-TBI instrument, a 37-item patient-centered measure that captures the individual's perception of his/her health-related quality-of-life in the domains of cognition, self-care, daily life and autonomy, social relationships, emotions, and physical functioning. Scores are summed and range from 0 to 148. Higher scores indicate better quality of life. It will be administered at the Baseline interview (T1), Month 4 interview (T2), and Month 10 interview (T3).

  four months and ten months

• Patient-identified problems: symptom management and self-efficacy

  Patient-identified problems are patient-centered measures, using questions to elicit the most serious TBI-related problems as articulated by participants themselves. Questions are (1) "What is the #1 (then #2/#3) problem that TBI has caused you within the last month?" (2) symptom management difficulty ("How difficult is it to manage this problem?" and (3) self-efficacy ("How confident are you in your ability to manage the problem?") on 5-point Likert scale, from 0 to 4, with 4 indicating highest difficulty and highest self-efficacy, respectively. These measures yield both qualitative and quantitative information and were sensitive to intervention effects in our previous study. A mean will be computed combining ratings of the 3 problems. It will be administered at the Baseline interview (T1), Month 4 interview (T2), and Month 10 interview (T3).

  four months and ten months

• Caregiver burden scores on the Caregiver Burden subscale of the Caregiver Assessment Scale (CAS) for the family member

  The 15-item burden subscale of the standard CAS instrument defines burden as the subjective perceptions of psychological distress, fatigue, anxiety, depression, poor health, social isolation, loss of freedom, feeling trapped, and resentment that are attributed directly to caregiving. A five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) is used. A mean score is computed. Higher scores indicate more burden. It will be administered at the Baseline interview (T1), Month 4 interview (T2), and Month 10 interview (T3).

  four months and ten months

• Depressive symptom scores on the CES-D for the family member

  Depressive symptoms will be measured by The Center for Epidemiologic Studies Depression Scale short form (CES-D). The CES-D is a well-established 10-item screening instrument that shows strong psychometric properties in TBI populations. Each question is followed by a four-point Likert scale (0=never or rarely, 3=most or almost all the time). Scores are summed and range from 0 to 30, with higher scores indicating greater depression. It will be administered at the Baseline interview (T1), Month 4 interview (T2), and Month 10 interview (T3).

  four months and ten months

• Family needs scores on the Family Needs Questionnaire (FNQ)-Revised

  The 37-item Family Needs Questionnaire-Revised (FNQ-R) measures the extent to which family needs are met. Factor analytically derived scales include: Health Information, Emotional Support, Instrumental Support, Professional Support, Community Support Network, and Involvement with Care. Participants are first asked whether the item is a need for them now, and if it is, the extent to which the need has been met. This uses a 3-point scale (yes=1, partly=2, no=3). Scores are summed and can range from 37 to 111, with higher scores indicating that fewer needs are met. It will be administered at the Baseline interview (T1), Month 4 interview (T2), and Month 10 interview (T3).

  four months and ten months

Study Arms (2)

HOME for Us

EXPERIMENTAL

The HOME intervention is the delivery of an in-home, family inclusive, rehabilitation intervention in eight sessions. Six of the sessions will occur in the home, and two 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: HOME for Us

Attention Control

ACTIVE COMPARATOR

The Attention-control condition is the delivery of educational materials over 8 contacts. Three 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.

Behavioral: Attention-control condition

Interventions

HOME for Us BEHAVIORAL

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).

HOME for Us

Attention-control condition BEHAVIORAL

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.

Attention Control

Eligibility Criteria

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

You may qualify if:

• TBI Participant:
• English speaking
• years or older
• Most recent TBI at least 1 year ago
• Has participating family member living with person with TBI
• Willing/able to provide informed consent
• Meets criteria for mild, moderate, or severe TBI
• Acknowledges TBI-related symptoms at screening
• Family Member
• Family member, partner, or significant other
• Living with person with TBI
• years or older
• Actively involved in the person's life
• English speaking
• Willing/able to provide informed consent

You may not qualify if:

• TBI Participant:
• Dementia based on (a) physician diagnosis of dementia and/or (b) participant's difficulty in comprehending interview questions
• History of recent violence
• Aphasia
• Recent psychosis
• Family Member
• None

Sponsors & Collaborators

• Villanova University: lead
• University of Pennsylvania: collaborator
• Thomas Jefferson University: collaborator
• Drexel University: collaborator
• Louisiana State University Health Sciences Center - New Orleans: collaborator

Study Sites (1)

Villanova University

Villanova, Pennsylvania, 19085, United States

RECRUITING

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

• Helene Moriarty, PhD, RN, FAAN

  Villanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.

  PRINCIPAL INVESTIGATOR

• Laraine Winter, PhD

  Villanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Dinella, B.S.

CONTACT

610-519-4504; Janet.dinnella@villanova.edu

Helene Moriarty, PhD, RN, FAAN

CONTACT

610-519-5735; Helene.moriarty@villanova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants are assigned to an Arm (HOME treatment or Attention-control condition) after the first (T1) interview. The interviewers are blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design is a two group, randomized controlled trial. The study uses a stratified permuted block randomization, with blocks varying in size of 4 to 6, to conceal treatment allocation and control for possible changes over time in the subject mix. To ensure proper group balance, stratification on sex and civilian/veteran status will be conducted. The study statistician will develop the blocking number and provide a computer-generated randomization list. An intention to treat (ITT) model will be followed. Participants who do not wish to continue after the Time 1 baseline interview will not be randomized and will not count toward the accrual goals.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 11, 2021
• Study Start: December 22, 2021
• Primary Completion: November 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: The IDP will be shared starting six months after the publication.
• Access Criteria: A final dataset will be made available to other investigators upon receipt of a study-specific Data Use Agreement made in writing and following Villanova University Institutional Review Board regulations and VA Institutional Review Board and Research \& Development regulations. It will be provided electronically and per Villanova and VA regulations for transferring data. All recommended steps will be followed to ensure that re-identifying participants from the final de-identified and anonymous dataset will not be possible. In addition, the Data Use Agreement will explicitly prohibit attempts to re-identify participants.

Locations

US (1)