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

NCT05929833 | Enrolling By Invitation

• 1 other identifier: Pro00112309
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

transitional care; patients; family caregivers

Outcome Measures

Primary Outcomes (1)

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

  The SF-36 is a quality of life (QOL) measurement with a score range of 0 to 100, where a higher score indicates a better outcome.

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

Secondary Outcomes (19)

• Change in patient cognitive function (Neuro-QOL, Cognitive functioning)

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

• Change in patient physical functioning (Neuro-QOL, Upper & Lower extremity functioning)

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

• Change in patient sleep disturbance (NeuroQOL Sleep Disturbance, short-form)

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

• Change in patient TBI-related symptoms (Rivermead Post-concussion questionnaire)

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

• Change in patient participation [Participation Assessment with Recombined Tools-Objective (PART-O)]

  8-, 16-, and 24-weeks post-discharge

Other Outcomes (2)

• Demographics

  baseline (24-72 hours pre-discharge)

• Clinical Factors

  baseline (24-72 hours pre-discharge)

Study Arms (2)

BETTER TBI (Traumatic Brain Injury) Transitional Care Intervention

EXPERIMENTAL

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.

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

Usual Care

PLACEBO COMPARATOR

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).

Other: Usual Care

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.

BETTER TBI (Traumatic Brain Injury) Transitional Care Intervention

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)

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Patients with TBI, regardless of insurance status, will be eligible if they are/have: * age 18 years or older; * diagnosed with mild, moderate, or severe TBI \[admission Glasgow Coma Scale score of 3-15\]; * admitted to a Duke University Hospital inpatient acute care unit; * plans to be discharged directly home from Duke University Hospital without inpatient rehabilitation or transfer to other settings (community discharge); * sufficient cognitive functioning to participate (i.e., able to follow 2-step commands), as determined by the Galveston Orientation and Amnesia Test (score \>76 eligible); * English- or Spanish-speaking (self-report); * access to a phone or computer with internet capabilities for study participation Patients with TBI will be excluded if they have/are: 1. Pre-injury neurologic conditions/disorder(s): The following neurological conditions/disorders are excluded: • untreated ADHD, cerebral palsy, stroke, multiple sclerosis, Parkinson's disease); pre-injury cognitive impairments (e.g., Alzheimer's disease and related dementias); and developmental disorders (e.g., autism, down's syndrome). The following neurological conditions are not being excluded: • transient ischemic attack, small vessel disease; essential tremor; concussion (maximum 2 prior concussions with no prior history of post-concussion syndrome); myasthenia gravis; dysautonomia; foot drop; degenerative disc disease; spine reticulopathy; bell's palsy + other cranial nerve palsy; neurogenic bladder (if in isolation); and epilepsy \[patients with epilepsy are eligible to participate if they had no hospital admissions or emergency department visit for seizures in the last 6 months\] 2. Severe psychiatric diagnosis (i.e., untreated schizophrenia, untreated bipolar 1 or 2, any indication of psychosis or acute psychotic events occurring) that are untreated with no psychiatric provider on record, which would preclude patients from having capacity to consent 3. Admitted from settings or locations other than home Family members will include patient-identified biological relatives and friends and are eligible if they are/have: * associated with a patient meets all above-listed patient criteria; * age 18 years or older; * an anticipated primary caregiver after discharge (i.e., plans to live in same home as patient or have direct contact with patient \>10 hours/week); * English- or Spanish-speaking (self-report); * access to a phone or computer with internet capabilities for study participation. Family members will be excluded if the associated patient is not eligible or declines participation.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Oyesanya TO, Ibemere SO, You H, Emerson MM, Pan W, Palipana A, Kandel M, Ingram D, Soto M, Pioppo A, Albert B, Walker-Atwater T, Hawes J, Komisarow J, Ramos K, Byom L, Gonzalez-Guarda R, Van Houtven CH, Agarwal S, Prvu Bettger J. Efficacy of BETTER transitional care intervention for diverse patients with traumatic brain injury and their families: Study protocol of a randomized controlled trial. PLoS One. 2024 Feb 23;19(2):e0296083. doi: 10.1371/journal.pone.0296083. eCollection 2024.

  PMID: 38394279 BACKGROUND

Related Links

• Efficacy of BETTER transitional care intervention for diverse patients with traumatic brain injury and their families: Study protocol of a randomized controlled trial

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Tolu O Oyesanya, PhD, RN

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: July 3, 2023
• Study Start: January 26, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)