500 Participants Needed

BETTER Program for Traumatic Brain Injury

TO
Overseen ByTolu O Oyesanya, PhD, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University

Trial Summary

What is the purpose of this trial?

Despite racial/ethnic disparities in outcomes for younger adults with traumatic brain injury (TBI), there are no U.S. standards for TBI transitional care for patients discharged home from acute hospital care. To enhance the standard of care, the investigators will examine the efficacy of the existing intervention named BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery), a culturally-tailored, patient- and family-centered TBI transitional care intervention, compared to usual care, among younger adults with TBI and families. The knowledge generated will drive improvements in health equity for younger adults with TBI of various races/ethnicities and families, resulting in improved health of the public.

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.

How is the BETTER treatment for traumatic brain injury different from other treatments?

The BETTER treatment is unique because it combines education, training, and therapy specifically designed to enhance recovery from traumatic brain injury, focusing on a comprehensive approach rather than just medical or physical rehabilitation.12345

Research Team

TO

Tolu O Oyesanya, PhD, Rn

Principal Investigator

Duke University School of Nursing

Eligibility Criteria

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:
See 6 more

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.
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BETTER TBI (Traumatic Brain Injury) Transitional Care InterventionExperimental Treatment1 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 CarePlacebo Group1 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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

References

Return to School After Traumatic Brain Injury: Description of Implementation Settings. [2023]
Rehabilitation of the severely brain-injured patient: a community-based, low-cost model program. [2004]
Digital Gaming for Improving the Functioning of People With Traumatic Brain Injury: Protocol of a Feasibility Study. [2023]
The utility of the FIM+FAM for assessing traumatic brain injury day program outcomes. [2019]
Traumatic brain injury: A case-based review. [2021]
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