HOME Program for Traumatic Brain Injury

(HOME Trial)

Overseen By Jan Dinella, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Villanova University

Disqualifiers: Dementia, Recent violence, Aphasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals living with traumatic brain injury (TBI) symptoms for over a year. The study tests a program called HOME for Us, where occupational therapists visit participants' homes to help them and their families manage TBI-related challenges. The goal is to enhance the quality of life for both the person with TBI and their family by focusing on the home environment and family support. Individuals who experienced a TBI at least a year ago and continue to face symptoms, along with a family member living with them, may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in TBI care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this rehabilitation intervention is safe for persons with chronic TBI-related symptoms?

Research has shown that the HOME program, a home-based therapy for individuals with long-term symptoms from traumatic brain injury (TBI), yields promising results. Similar studies have found that personalized rehabilitation programs conducted at home can enhance quality of life and alleviate symptoms without major safety concerns. Occupational therapy guidelines also endorse these treatments, emphasizing their benefits and safety for adults with TBI.

As a non-drug, therapy-based approach, the HOME program is generally well-tolerated. It involves occupational therapists collaborating with patients and their families in their homes. This personalized, home-focused approach addresses the specific needs of those with TBI and has not been associated with significant negative effects in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HOME for Us program is unique because it delivers rehabilitation for traumatic brain injury directly in the home environment, involving family members in the process. This approach contrasts with traditional treatments that typically require patients to attend rehabilitation sessions in clinical settings. By integrating family support and focusing on a familiar environment, researchers believe this method could enhance recovery and make it easier for patients to apply what they learn to their daily lives. Plus, the involvement of occupational therapists ensures personalized care tailored to individual needs, potentially leading to more effective outcomes.

What evidence suggests that the HOME Program is effective for chronic TBI symptoms?

Research has shown that home-based therapy can improve the quality of life for people with long-term traumatic brain injury (TBI). In this trial, participants may receive the HOME for Us program, which provides personalized rehabilitation at home to reduce symptoms and enhance daily living skills. Family involvement in the therapy supports these improvements and helps maintain progress. Occupational therapy, included in the HOME for Us program, is linked to better outcomes in managing TBI-related challenges. This approach focuses on adjusting home environments to align with individuals' needs and strengths, making everyday life easier. ^{1 2 3 4 6}

Who Is on the Research Team?

Laraine Winter, PhD

Principal Investigator

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

Helene Moriarty, PhD, RN, FAAN

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for individuals with chronic symptoms from a traumatic brain injury (TBI) that occurred over a year ago, and their family members who live with them and are actively involved in their lives. Participants must be adults who speak English and can consent to the study. It's not for those with dementia, recent violence or psychosis, or difficulty understanding interview questions.

Inclusion Criteria

The participant must be living with someone who has a traumatic brain injury (TBI).

I am willing and able to give my consent to participate.

TBI Participant must acknowledge TBI-related symptoms at screening

Exclusion Criteria

I have a history of recent violence and have experienced a traumatic brain injury.

I have difficulty speaking or understanding language due to a brain injury.

I have experienced psychosis recently after a brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the HOME intervention, consisting of 6 in-home sessions and 2 phone sessions over four months, focusing on managing TBI-related symptoms through environmental modifications and family education.

16 weeks

6 in-home visits, 2 phone sessions

Follow-up

Participants are monitored for maintenance of treatment effects and generalization of skills to new problems or contexts.

6 months

Follow-up interviews conducted by phone or in-home

Long-term Follow-up

Assessment of long-term maintenance of treatment effects and generalization of skills 10 months after baseline.

10 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention-control condition
• HOME for Us

Trial Overview The HOME Program is being tested; it's an at-home occupational therapy intervention designed to help TBI patients manage symptoms and improve quality of life. Over four months, therapists work with patients and families on strategies tailored to individual needs within the home environment.

How Is the Trial Designed?

Group I: HOME for Us Experimental Treatment 1 Intervention

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).

Group II: Attention Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Villanova University

Lead Sponsor

Trials

8

Recruited

3,200+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Louisiana State University Health Sciences Center - New Orleans

Collaborator

Trials

2

Recruited

520+

Published Research Related to This Trial

The study of 24 women in a supportive housing program revealed significant deficits in independent living skills, particularly in money management, highlighting a critical area for intervention.

Traumatic experiences and PTSD were found to be more common among homeless women compared to the general population, indicating a need for occupational therapy to address both mental health and practical living skills in this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Independent living skills and posttraumatic stress disorder in women who are homeless: implications for future practice. Davis, J., Kutter, CJ.[2022]

Home-based cognitive training for patients with acquired brain injury can enhance the intensity of rehabilitation, leading to better outcomes in cognitive recovery.

This approach allows for improved generalization of skills learned during formal training to everyday activities, making it easier for patients to utilize their pre-existing cognitive strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home and family in cognitive rehabilitation after brain injury: Implementation of social reserves. Mogensen, J., Wulf-Andersen, C.[2018]

A study involving 98 adults with neurological conditions showed that outpatient occupational therapy significantly improved independence in basic activities of daily living (ADL), with a large effect size (r = 0.59).

Factors associated with better outcomes included having acquired brain injury, receiving fewer hours of caregiver assistance, and higher intensity of occupational therapy, while younger male patients tended to have better therapy efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of improvement of functional independence in a multicentre cohort of rehabilitation outpatients with neurological conditions. Huerta-Mareca, R., De-Rosende-Celeiro, I., Ares-Senra, L., et al.[2023]

A recent randomized trial found no significant difference in outcomes between home-based and inpatient cognitive rehabilitation for patients with moderate to severe head injuries.

The home program included medical treatment, a multidisciplinary evaluation, TBI counseling, and weekly support from a psychiatric nurse over an eight-week period, highlighting a structured approach to rehabilitation at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A home program of rehabilitation for moderately severe traumatic brain injury patients. The DVHIP Study Group. Warden, DL., Salazar, AM., Martin, EM., et al.[2019]

The Veterans' In-home Program (VIP) significantly improved family members' well-being by reducing depressive symptoms and caregiver burden compared to standard outpatient care, based on a randomized controlled trial with 81 veteran-family dyads.

Family members found the VIP intervention highly acceptable, indicating that it effectively addresses the needs of both veterans with traumatic brain injury and their families, filling a crucial gap in existing support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial to Evaluate the Veterans' In-home Program for Military Veterans With Traumatic Brain Injury and Their Families: Report on Impact for Family Members. Moriarty, H., Winter, L., Robinson, K., et al.[2021]

Home-based occupational therapy interventions for adults post-stroke show potential benefits in improving patient outcomes, although the number of efficacy studies is limited.

Current research lacks sufficient use of occupation-based assessments and methodologies, indicating a need for improved study designs and more high-quality research to better evaluate the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy Studies of Home-Based Occupational Therapy Services Following Stroke: A Scoping Review. Zachry, AH., Williams, L., Chen, M., et al.[2023]

Conducting home-based occupational therapy research with culturally diverse populations, such as Canadian and immigrant South Asian and Chinese mothers of premature infants, requires a culturally sensitive recruitment process and the use of appropriate research instruments.

Involving a diverse research team and being adaptable to feedback are crucial for effectively addressing the unique needs and values of different cultural groups in occupational therapy studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research lessons learned: occupational therapy with culturally diverse mothers of premature infants. Reid, DT., Chiu, TM.[2017]

Acquired brain injury (ABI) not only impacts the patient but also significantly affects their family, highlighting the need for therapeutic approaches that include family support.

Supplementing institution-based cognitive rehabilitation with home-based training can enhance recovery outcomes, but it also poses challenges for family dynamics and psychological well-being, suggesting a need for family-based intervention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family and home in cognitive rehabilitation after brain injury: The importance of family oriented interventions. Wulf-Andersen, C., Mogensen, J.[2018]

The AOTA Evidence-Based Practice Project has created a comprehensive table that outlines research opportunities for occupational therapy interventions in adults with traumatic brain injury, based on systematic reviews.

This resource serves as a valuable tool for researchers, students, and clinicians to identify gaps in current evidence and develop innovative studies to enhance occupational therapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Opportunities in the Area of Adults With Traumatic Brain Injury. [2017]

This case report highlights the application of evidence-based interventions for an adult with traumatic brain injury (TBI), utilizing systematic reviews from the American Occupational Therapy Association (AOTA).

The report details the occupational therapy assessment and treatment processes across various settings, including hospital, home, and community, demonstrating the practical use of research in real-world therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapy Interventions for Adults With Traumatic Brain Injury. Wheeler, S., Acord-Vira, A., Arbesman, M., et al.[2017]

A review of 13 studies involving older adults (60 years and older) found that home-based occupational therapy (OT) significantly improves occupational performance through cognitive, behavioral, and environmental strategies.

While the improvements in occupational performance were notable, maintaining these gains over time was identified as a challenge, suggesting a need for further development of high-intensity and maintenance OT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the short-term and long-term effects of occupation-focused and occupation-based occupational therapy in the home on older adults' occupational performance? A systematic review. Nielsen, TL., Petersen, KS., Nielsen, CV., et al.[2022]

In a study of 435 adults with traumatic brain injury (TBI), higher utilization of occupational therapy was linked to greater improvements in activities of daily living (ADL) performance, indicating its efficacy in rehabilitation.

Interestingly, despite these improvements, patients who received more occupational therapy were actually less likely to be discharged to community settings, suggesting a complex relationship between therapy intensity and discharge outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in Activity Performance Mediates the Relationship between Occupational Therapy Utilization and Discharge Disposition among Adults with Traumatic Brain Injuries. Bukhari, RA., Kinney, AR., Edelstein, J., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05117619

The HOME Program for Individuals With Traumatic Brain ... This purpose of this study is to evaluate an innovative rehabilitation intervention for persons with chronic TBI-related symptoms (1 year or more post ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10163390/

Effect of an Individually Tailored and Home-Based ... These findings suggest that an individually tailored and goal-oriented rehabilitation program might be effective in improving generic HRQOL and symptom burden ...

3. withpower.com withpower.com/trial/phase-brain-injuries-traumatic-10-2021-858c8

HOME Program for Traumatic Brain Injury (HOME Trial) Some studies suggest that home-based occupational therapy can improve outcomes for stroke patients, and high utilization of occupational therapy in acute care ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2804559

Effect of an Individually Tailored and Home-Based ... These findings suggest that an individually tailored and goal-oriented rehabilitation program might be effective in improving generic HRQOL and symptom burden ...

5. research.aota.org research.aota.org/ajot/article/77/4/7704397010/24930/Occupational-Therapy-Practice-Guidelines-for

Occupational Therapy Practice Guidelines for Adults With ... These Practice Guidelines provide a summary of evidence in clinical recommendations tables supporting occupational therapy interventions that address ...

6. journals.lww.com journals.lww.com/iopt/fulltext/2021/53010/rehabilitation_outcomes_of_persons_with_severe.5.aspx

Rehabilitation Outcomes of Persons with Severe Traumatic... This study examines whether persons with severe TBI who completed an 8–12 weeks of inpatient rehabilitation in the rehabilitation center achieved significant ...