BETTER Program for Traumatic Brain Injury

Overseen By Tolu O Oyesanya, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Epilepsy, Stroke, Schizophrenia, others

Compensation: Varies

Number of Visits: 8

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for adults with traumatic brain injuries (TBI) by testing a program called BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery). BETTER focuses on education, training, and therapy to assist patients and their families after hospital discharge. Participants will receive either the BETTER intervention or standard care, enabling researchers to compare outcomes and identify better ways to support recovery. This trial may suit individuals treated for a TBI at Duke University Hospital who plan to go home directly from the hospital, with a family member or friend available for support. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research aimed at enhancing recovery for TBI patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the BETTER program is safe for TBI patients?

Research has shown that the BETTER program is designed to assist patients with traumatic brain injury (TBI) after hospital discharge. Studies have evaluated the program's usability and participant satisfaction. So far, no serious side effects or harm have been reported.

The BETTER program provides education and training to support patients and their families in managing recovery at home. This support aims to ease the transition from hospital to home effectively. By focusing on guidance and support rather than drugs or medical devices, the program reduces the risk of physical side effects.

Overall, the program seeks to meet the needs of TBI patients and their families without introducing known risks, making it a safe option for those considering participation in a study on improving TBI care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BETTER Program for Traumatic Brain Injury because it offers a personalized approach to recovery that goes beyond the standard discharge planning and follow-up care. Unlike typical treatments that focus mainly on medical management and physical rehabilitation, the BETTER program uses skilled interventionists to create tailored plans addressing both patient and family needs. This comprehensive approach includes setting goals, coordinating care, and teaching coping skills, which aims to enhance both self- and family-management during the critical 16 weeks post-discharge. By integrating education and support directly into the recovery process, the BETTER program hopes to significantly improve outcomes for TBI patients and their families.

What evidence suggests that the BETTER program is effective for traumatic brain injury?

Research has shown that the BETTER program, which participants in this trial may receive, can enhance the physical well-being of adults with traumatic brain injury (TBI). One study found that participants' physical well-being scores improved from 30.3 at the beginning to 46.5 after 16 weeks. This suggests that the program may aid in physical recovery after a TBI. By addressing the needs of patients and their families, setting goals, and coordinating care, the program may contribute to these improvements. ^{1 3 5 6 7}

Who Is on the Research Team?

Tolu O Oyesanya, PhD, RN

Principal Investigator

Duke University School of Nursing

Are You a Good Fit for This Trial?

The BETTER trial is for younger adults aged 18-64 with mild to severe traumatic brain injury (TBI) who are being discharged home from acute hospital care. Participants must be able to follow commands, speak English or Spanish, and have phone access. Primary caregivers of the patients can also join if they're over 18 and meet similar language and phone requirements.

Inclusion Criteria

I plan to go home directly after being discharged from Duke University Hospital.

I have been diagnosed with a traumatic brain injury of any severity.

Patients with TBI of any race/ethnicity, regardless of insurance status, will be eligible if they are/have:

Exclusion Criteria

Unable to identify a family member to participate with them in the study

My family member cannot join if I am not eligible or if I choose not to participate.

I do not have an untreated severe psychiatric condition that affects my ability to consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BETTER intervention, a culturally-tailored, patient- and family-centered TBI transitional care intervention, for up to 16 weeks post-discharge

16 weeks

Weekly sessions with clinical interventionists

Follow-up

Participants are monitored for changes in quality of life and other health outcomes post-treatment

8 weeks

Follow-up assessments at 8, 16, and 24 weeks post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery)

Trial Overview This study compares a special program called BETTER, which includes education, training, and therapy tailored for TBI patients and their families, against the usual care given after discharge from the hospital. It aims to improve recovery outcomes in racially diverse young adults with TBI.

How Is the Trial Designed?

Group I: BETTER TBI (Traumatic Brain Injury) Transitional Care Intervention Experimental Treatment 1 Intervention

Skilled clinical interventionists follow a manualized intervention protocol to address patient/family needs; establish goals; coordinate post-hospital care, services, and resources; and provide patient/family education and training on self- and family-management and coping skills \<16 weeks post-discharge.

Group II: Usual Care Placebo Group 1 Intervention

In alignment with U.S. usual care for patients with TBI (Traumatic Brain Injury), usual care arm activities for younger adults with TBI and their family caregivers will includes usual care discharge planning process and follow up (e.g., verbal and written discharge instructions, with guidance on medications, outpatient therapy, and follow-up appointments).

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10947151/

The BETTER Traumatic Brain Injury Transitional Care ... Overall and mental QOL scores did not differ over time but physical QOL scores did improve over time (baseline: 30.3, 8-weeks: 46.5, 16-weeks: ...

2. dukespace.lib.duke.edu dukespace.lib.duke.edu/items/405bb649-6e8c-48ac-8bd2-bab955c16061

Study protocol of a randomized controlled trial. - DukeSpace The purpose of this study is to examine the efficacy of BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) vs. usual transitional care ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35174756/

a transitional care intervention for younger adult patients with ... BETTER is among the first TBI transitional care intervention to address needs/preferences for younger TBI patients of different racial groups after ...

4. cdc.gov cdc.gov/traumaticbraininjury/pdf/tbi_report_to_congress_epi_and_rehab-a.pdf

Traumatic Brain Injury In the United States: Epidemiology ... A survey of accredited and other rehabilitation facilities: Education, training, and cognitive rehabilitation in brain-injury programmes. Brain Injury, 7(4) ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1608645/full

A comprehensive review of rehabilitation approaches for ... This comprehensive review critically examines key rehabilitation strategies for TBI, including neuropsychological assessments, cognitive and neuroplasticity- ...

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/01939459231189786

The BETTER Traumatic Brain Injury Transitional Care ... BETTER is a promising intervention with implications to improve TBI care standards. Research is needed to determine efficacy in a randomized trial.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324011717

Model of Care for Chronic Brain Injury This model is intended to address the needs of people with chronic brain injury by facilitating effective use of health care and community resources.