BETTER Program for Traumatic Brain Injury

N/A

Waitlist Available

Led By Tolu O Oyesanya, PhD, Rn

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

Summary

This trial is looking at a program called BETTER that helps people with traumatic brain injuries (TBI) as they transition from the hospital to home. The program is designed to be culturally-sensitive and focused

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves educational and therapeutic interventions rather than medications, traditional side effects are not applicable. However, participants may experience varying levels of stress or emotional discomfort during the recovery process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in patient SF-36 (36-item Short Form Survey) score

Secondary study objectives

Change in Patient Activation Measure (PAM-10) for patients and caregivers.

Change in caregiver Modified Caregiver Strain Index (MCSI)

Change in caregiver Preparedness for Caregiving Scale

+16 more

Other study objectives

Clinical Factors

Demographics

Trial Design

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).

Do I qualify?Apply below to find out