What side effects are associated with this type of intervention?

The HOME program for managing chronic TBI symptoms through home-based occupational therapy and environmental management generally has minimal side effects. However, patients may experience fatigue, frustration, or emotional distress as they adapt to new strategies and routines. Additionally, the involvement of family members in the therapy process can sometimes lead to increased caregiver burden or stress. Overall, these treatments are considered safe and focus on improving quality of life and functional abilities.

What prior FDA approvals exist?

There are no specific FDA-approved treatments that directly align with the HOME program's approach of home-based occupational therapy for TBI. However, various pharmacological treatments and rehabilitation strategies are used to manage TBI symptoms. These include medications for symptom management such as pain relievers, antidepressants, and anti-anxiety drugs. Rehabilitation therapies, including physical, occupational, and speech therapy, are commonly employed to help patients regain function and improve quality of life. The HOME program's innovative approach of targeting the home environment to support individual strengths and deficits represents a novel, non-pharmacological strategy in TBI management.

What other types of research exist?

Promising novel alternatives to the HOME program for TBI patients include: 1) Virtual Reality (VR)-based rehabilitation, which uses immersive environments to enhance cognitive and motor skills. 2) Telehealth platforms that provide remote, personalized therapy sessions and continuous monitoring. 3) Integrative approaches combining cognitive-behavioral therapy (CBT) with physical rehabilitation to address both mental and physical aspects of TBI. 4) Neurofeedback therapy, which trains patients to regulate brain activity to improve cognitive function and reduce symptoms. These alternatives leverage technology and personalized care to manage chronic TBI symptoms effectively.

← Back to Search

HOME Program for Traumatic Brain Injury (HOME Trial)

N/A

Recruiting

Led By Laraine Winter, PhD

Research Sponsored by Villanova University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

TBI Participant must meet criteria for mild, moderate, or severe TBI

TBI Participant must be English speaking

Must not have

TBI Participant with history of recent violence

TBI Participant with aphasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up four months and ten months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a home-based therapy program called HOME for people with long-term TBI symptoms and their families. Therapists visit homes to help adjust the living environment and teach coping strategies. The goal is to improve patients' quality of life and reduce caregiver stress.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves non-medical therapeutic activities focused on rehabilitation rather than drugs or surgery, traditional side effects are not expected. However, there may be emotional or psychological impacts as participants adjust to new routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a traumatic brain injury classified as mild, moderate, or severe.

Select...

I speak English.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I have experienced psychosis recently after a brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four months and ten months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four months and ten months

This trial's timeline: 3 weeks for screening, Varies for treatment, and four months and ten months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HOME for UsExperimental Treatment1 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 ControlActive Control1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Traumatic Brain Injury (TBI) often involve a combination of occupational therapy, physical therapy, and cognitive rehabilitation. These therapies work by realigning environmental demands to match the individual's strengths and deficits, thereby helping to manage chronic TBI symptoms. For instance, occupational therapy focuses on improving the patient's ability to perform daily activities by modifying the home environment and teaching adaptive strategies. Physical therapy aims to enhance mobility and physical function, while cognitive rehabilitation targets the improvement of cognitive skills such as memory and attention. These interventions are crucial for TBI patients as they promote independence, improve quality of life, and facilitate better community reintegration.

Randomized Controlled Trials of Rehabilitation Services in the Post-acute Phase of Moderate and Severe Traumatic Brain Injury - A Systematic Review.Critical appraisal of systematic reviews of executive function treatments in TBI.

Find a Location

Who is running the clinical trial?

Villanova UniversityLead Sponsor

7 Previous Clinical Trials

2,781 Total Patients Enrolled

Drexel UniversityOTHER

156 Previous Clinical Trials

47,832 Total Patients Enrolled

Thomas Jefferson UniversityOTHER

465 Previous Clinical Trials

176,413 Total Patients Enrolled

University of PennsylvaniaOTHER

2,084 Previous Clinical Trials

42,726,608 Total Patients Enrolled

Louisiana State University Health Sciences Center - New OrleansUNKNOWN

1 Previous Clinical Trials

80 Total Patients Enrolled

Laraine Winter, PhDPrincipal InvestigatorVillanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.

1 Previous Clinical Trials

172 Total Patients Enrolled

Helene Moriarty, PhD, RN, FAANPrincipal InvestigatorVillanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.

1 Previous Clinical Trials

36 Total Patients Enrolled