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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05929833
Status
Enrolling By Invitation

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) — BEHAVIORAL
    The six components of BETTER include: 1) assessment of patient/family needs and referral to community-based resources; 2) patient goal setting and review of goals; 3) health care coordination; 4) availability of clinical interventionist to patient/family; 5) training on self- and family-management and brain injury coping skills; and 6) warm hand off/referral to the state-affiliated Brain Injury Association at the end of the intervention for additional resources.
  • Usual Care — OTHER
    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)

Study Details

Despite poor outcomes for 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, we will examine the efficacy of our existing intervention named BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery), a patient- and family-centered TBI transitional care intervention, compared to usual care, among adults with TBI and families. The knowledge generated will drive improvements in outcomes for adults with TBI and families, resulting in improved health of the public.

Key Dates

Start date
Jan 26, 2024
Status verified
Oct 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: BETTER TBI (Traumatic Brain Injury) Transitional Care 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.
  • Placebo Comparator: Usual Care
    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).

Primary Outcome Measure

Change in patient SF-36 (36-item Short Form Survey) score [ Time Frame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University HospitalDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Hospital· Durham, NC

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