Clinical trial NCT05117619: The HOME Program for Individuals With Traumatic Brain Injury and Family Members
Official title: A Randomized Controlled Trial of an Innovative In-home Rehabilitation Program for Persons With TBI and Their Families: Home-based Occupational-therapy and Management of the Environment (HOME for Us)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injuries, Traumatic
Keywords: Veterans
Family Caregiving
Rehabilitation
Quality of Life
Community Integration
Lead sponsor: Villanova University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Thomas Jefferson University
name: Drexel University
name: Louisiana State University Health Sciences Center - New Orleans
First posted: 2021-11-11
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Recognized as a major public health problem for civilian and military populations, traumatic brain injury (TBI) produces a broad range of cognitive, emotional, behavioral, and physical symptoms. These symptoms often impede community reintegration (participation in family, work, school, meaningful activities) and decrease quality of life (QoL). TBI also has a profound impact on family caregivers, who often struggle with depression, high levels of burden from caregiving demands, and many unmet needs.

Current approaches to TBI care typically provide post-acute rehabilitation for recent injuries (within 1 year after injury). Yet, years after injury, many individuals still experience chronic TBI symptoms that are difficult to manage and interfere with community reintegration (CR) and QoL. Standard post-acute TBI rehabilitation focuses on medical restoration to reduce specific deficits (e.g., memory loss) rather than on symptom management. Rehabilitation occurs in the clinic and assumes that learned strategies will be generalized to the home and community, despite evidence to the contrary. Families - widely acknowledged as essential to successful rehabilitation - are seldom systematically engaged in clinic-based care. Further, few rehabilitation approaches are delivered in the home, where daily functioning takes place, or target the home environment for intervention. Thus, a gap in practice and research exists concerning optimal approaches to patient and family management of chronic TBI sequelae.

The study tests an innovative rehabilitation approach for persons with chronic TBI-related symptoms (at least 1 year post injury) and their families, HOME (Home-based Occupational-therapy and Management of the Environment). Based on the person-environment fit framework, HOME targets the home environment (physical and social) to realign environmental demands to individual strengths and deficits. It engages persons with TBI and family caregivers in strategies to manage chronic TBI symptoms. Participants in the HOME group work with an occupational therapist (OT) on strategies to manage TBI-related symptoms or related difficulties in eight sessions taking place over four months.

The Primary Aims of the study are to:

1. Test treatment effects on patients' community reintegration (primary outcome), quality of life, and ability to manage self-identified TBI problems, assessed at the completion of the intervention (T2).
2. Test treatment effects on caregivers' depressive symptoms, burden, and met family needs at T2.

The Secondary Aims are to:

1. Test maintenance of treatment effects for patients and caregivers 6 months after treatment completion (T3).
2. Identify active components of the intervention at T2, using quantitative analysis and qualitative interviews.
3. Assess if treatment effects at T2 differ by civilian vs. veteran status, sex, age, TBI severity, or time since the index injury, indicating whether some subgroups benefit more than others from HOME (moderation effects).

An Exploratory Aim is to test whether strategies learned in HOME are generalized or applied to new problems or situations, beyond the treatment phase, assessed 6 months after completing the intervention (T3).

The HOME Intervention. HOME was based on findings from the investigators' earlier NIH-funded randomized controlled trial (1R21HD068857) testing an in-home, family-inclusive intervention for veterans with TBI and key family members, the Veteran's In-home Program (VIP). HOME builds on VIP by extending it to civilians with TBI, using the treatment protocol and interview manuals developed in that study, and broadening outcomes to include quality of life (QoL) and family needs. HOME also uses a 10-month follow-up (T3) to test maintenance of treatment effects over time and generalization of skills to new problems or contexts.

Focusing both on persons with TBI and family caregivers, HOME combines empirically-derived strategies supported by the team's earlier research with TBI and other clinical populations. Its components involve strategies designed to manage TBI-related symptoms through modification of the physical and social environment of the home. In its family focus, HOME provides family members with TBI education both in general and in relation to their relative's TBI symptoms; skills training on managing TBI-related problems; and strategies for their own stress management. It is designed to be transportable into practice within the VA and private sector health systems and deliverable by occupational therapists (OTs), who are commonly members of rehabilitation teams.

HOME consists of 6 in-home sessions each lasting approximately 1 to 1.5 hours, and 2 phone sessions of 15 minutes each, delivered over four months. A manualized intervention, HOME components are tailored to patient symptoms, strengths, and deficits; needs of families; and home environments. The six components of the intervention are: environmental modification strategies/equipment, simplification and/or modification of tasks/activities, activity enhancement, stress reduction, emotion regulation, and TBI knowledge.

Overview of research design. A 2-group randomized controlled trial (RCT) will be conducted to compare HOME to an attention-control condition. The RCT uses intention-to-treat principles, concealed allocation for randomization, multiple diverse recruitment sites, and blinded follow-up interviews. Delivery of the intervention in the home minimizes contamination.

Guided by the 2019 NIH Expert Panel Pragmatic Model for Comparator Selection for Behavioral Trials, an attention-control condition will be used to distinguish the specific effect of treatment from effects of non-specific components (e.g., staff attention). Attention-control condition participants will receive TBI information and discussion distinct from the HOME intervention: three information sessions (conducted on-line or teleconference), 3 supportive phone calls, and 2 informational mailings. Both HOME and attention-control groups will receive usual care. Formal care and services will be assessed in all interviews, to control for differential service utilization.

The sample will consist of 220 dyads (persons with TBI with chronic TBI-related symptoms and their self-selected family caregivers). Approximately half of the persons with TBI will be veterans, recruited from an outpatient Rehabilitation Medicine Service in an urban VA medical center; the other half will be civilians, recruited from three outpatient civilian rehabilitation settings.

All study participants (individuals with TBI and family members in both study arms) will have three interviews. Each interview takes about 1 to 1.5 hours. The baseline (first) interview is conducted in the home and includes informed consent for the person with TBI and the family member. After the first interview, participants are randomized to receive the HOME treatment or the attention control condition. Follow-up interviews at 4 months (T2) will test immediate treatment effects and at 10 months (T3) will allow tests of maintenance of treatment gains and generalization effects. These follow-up interviews are conducted by phone or in the home.

Individual interviews with a subsample of 25 dyads who received HOME will be conducted, digitally recorded, and transcribed. The subsample will be purposively chosen to obtain heterogeneity in sociodemographic characteristics, TBI severity, and response to the intervention (those who did and did not benefit; those more and less engaged). These qualitative findings will yield a broader perspective on the process and impact of HOME, identify barriers and facilitators, and reasons for low engagement, following Gitlin's process evaluation model.

Eligibility criteria: Inclusion Criteria:

TBI Participant:

* English speaking
* 18 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
* 18 years or older
* Actively involved in the person's life
* English speaking
* Willing/able to provide informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Community reintegration (CR) scores on PART-O-17 for the person with TBI
timeFrame: four months and ten months
measure: Quality of life in TBI scores on the QoL-TBI instrument for the person with TBI
timeFrame: four months and ten months
measure: Patient-identified problems: symptom management and self-efficacy
timeFrame: four months and ten months
measure: Caregiver burden scores on the Caregiver Burden subscale of the Caregiver Assessment Scale (CAS) for the family member
timeFrame: four months and ten months
measure: Depressive symptom scores on the CES-D for the family member
timeFrame: four months and ten months
measure: Family needs scores on the Family Needs Questionnaire (FNQ)-Revised
timeFrame: four months and ten months
Secondary outcomes:
Other outcomes:
Locations:
city: Villanova
country: United States
facility: Villanova University
state: Pennsylvania
Study officials:
affiliation: Villanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.
name: Helene Moriarty, PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
affiliation: Villanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.
name: Laraine Winter, PhD
role: PRINCIPAL_INVESTIGATOR
References: