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BETTER (Educazione, formazione e terapia sulle lesioni cerebrali per migliorare il recupero)

2 novembre 2026 aggiornato da: Duke University

Uno studio controllato randomizzato di BETTER, un intervento di assistenza di transizione, per diversi pazienti con lesioni cerebrali traumatiche e le loro famiglie

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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Patients with TBI (age 18 and older) with mild-to-severe traumatic brain injury (TBI) face high incidence and hospitalization rates, and poor cognitive, physical, behavioral, and emotional impairments <12 months post-discharge. These impairments affect patients' abilities to independently manage their health, wellness, and activities of daily living, resulting in dependence on family. The complexity of needs combined with the fragmentation of healthcare services creates the perfect storm for low patient quality of life (QOL), mismanaged symptoms, rehospitalizations, and increased caregiver strain. Lack of insurance or access to care aggravate these ongoing issues. Despite complex health needs, there are no U.S. standards for transitional care for patients with TBI. Transitional care is defined as actions in the clinical encounter designed to ensure the coordination and continuity of healthcare for patients transferring between different locations or levels of care (e.g., acute hospital care to home). In other patient groups with acute events (e.g., stroke, myocardial infarction), transitional care interventions have led to improved patient QOL and health outcomes. Yet, few TBI transitional care interventions exist. The paucity of theory-driven, evidence-based TBI transitional care interventions led our team to develop an intervention named BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery). Based on the Individual and Family Self-Management Theory (IFSMT), BETTER is a patient- and family-centered, behavioral intervention for adults with TBI discharged home from acute hospital care and families. The goal is to improve patients' QOL (change in SF-36 total score, primary outcome) by 16-weeks post-discharge, as this timeframe includes high rates of unmet patient/family needs and preventable clinical events. 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. Findings from our NIH R03 pilot study showed BETTER significantly improved patients' physical QOL by 31.36 points (p = 0.006) and that the intervention was feasible and acceptable with adults with TBI and families. Thus, the purpose of this study is to examine the efficacy of BETTER (vs. usual care) among adults with TBI who are discharged home from acute hospital care and families. Findings will guide our team in designing a future, multi-site trial to disseminate and implement BETTER into clinical practice to ultimately drive advancements to enhance the standard of care for adults with TBI and families.

Tipo di studio

Interventistico

Iscrizione (Stimato)

500

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery)

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.
Comparatore placebo: 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).
Altro: Usual Care

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)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in patient SF-36 (36-item Short Form Survey) score
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in patient cognitive function (Neuro-QOL, Cognitive functioning)
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

The Neuro-QOL is a self-report of health related quality of life for individuals with neurological disorders. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient physical functioning (Neuro-QOL, Upper & Lower extremity functioning)
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

The Neuro-QOL is a self-report of health related quality of life for individuals with neurological disorders. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient sleep disturbance (NeuroQOL Sleep Disturbance, short-form)
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

The Neuro-QOL is a self-report of health related quality of life for individuals with neurological disorders. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient TBI-related symptoms (Rivermead Post-concussion questionnaire)
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

The Rivermead Post-concussion questionnaire is a self-reported measures of TBI-related symptoms. Scores on the first 3 items of the RPQ can range from 0 to 12, with higher scores indicated higher severity of early symptom clusters of post-concussive symptoms; scores on items 4 to 16 can range from 0 to 52, with higher scores indicating higher severity of later post-concussive symptoms
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)]
Lasso di tempo: 8-, 16-, and 24-weeks post-discharge

Participation will be measured using the Participation Assessment with Recombined Tools-Objective (PART-O), an objective measure of societal participation developed for patients with TBI with 24-items, with higher scores indicating higher levels of participation
8-, 16-, and 24-weeks post-discharge
Change in patient process of care transition [Care Transitions Measure-3 (CTM-3)]
Lasso di tempo: 8-, 16-, and 24-weeks post-discharge

The process of care transitions will be measured by the Care Transitions Measure-3, a 3-item scale with scores ranging from 0 to 100, with higher scores indicating less challenges with the transitional care process
8-, 16-, and 24-weeks post-discharge
Change in patient and caregiver difficulty accessing services [Service Obstacles Scale (SOS)]
Lasso di tempo: 8-, 16-, and 24-weeks post-discharge

Difficulty accessing services will be measured by the Service Obstacles Scale, a 6-item scale with scores ranging from 7 to 42, with higher scores indicating more difficulty accessing services
8-, 16-, and 24-weeks post-discharge
Change in patient and caregiver quality of life / health status (Euro Qol, 5 Item [EQ-5D-5L]) + VAS (visual analog scale) + Cognitive domain (C)
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

The EQ-5D-5L is a patient reported outcome consisting of 5 items asking about quality of life. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state. The VAS (visual analog scale) captures self-rated health. Patients with TBI will also complete the cognitive domain of the EuroQol (EQ-5D-5L+C), to capture condition specific issues, but caregivers will not.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient and caregiver multi-dimensional interpersonal processes of care in the clinical encounter [Interpersonal Processes of Care (IPC) short-form]
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

Multi-dimensional interpersonal processes in the clinical encounter, particularly discrimination in the clinical encounter, will be measured using the Interpersonal Processes of Care survey (short-form). The measure, which contains 18-items, has 7 domains using a 1 to 5 scale, with scores ranging from 18 to 90. Higher scores indicate a higher frequency of interpersonal challenges and discrimination in the clinical encounter.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient and caregiver depressive symptoms [PHQ-9 (Patient Health Questionnaire-9)]
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

The PHQ-9 assesses degree of depression severity via questionnaire. It has a score range of 0 to 27, where a higher score indicates greater depression.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient and caregiver Self-Efficacy for Management of Chronic Conditions Scale
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

The Self-Efficacy to Manage Chronic Disease Scale is made up of 6 items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). The total score range is 6 to 60, where a higher score indicates greater confidence.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient and caregiver alcohol and substance abuse (CAGE-AID Substance Abuse Screening Tool)
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

Alcohol and substance use will be measured using the CAGE-AID Substance Use Screening Tool, a 5-item measure with scores ranging from 0 to 4, with higher scores indicating higher possibility of substance use disorder and need for possible testing
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Score on patient and family personal health literacy (Self-Reported Health Literacy Questions)
Lasso di tempo: baseline (24-72 hours pre-discharge)

Health literacy will be measured using the Self-Reported Health Literacy Questions, a 3-item measure with scores ranging from 3-15, with higher scores indicating lower self-reported health literacy.
baseline (24-72 hours pre-discharge)
Number and type of healthcare services utilized
Lasso di tempo: 8-, 16-, and 24-weeks post-discharge

Measured by patient and/or caregiver proxy report of patient transitional health care utilization, using a survey developed by the team.
8-, 16-, and 24-weeks post-discharge
Change in caregiver Modified Caregiver Strain Index (MCSI)
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

The MCSI can quickly screen for caregiver strain in long-term caregivers. Scoring is 2 points for each 'yes', 1 point for each 'sometimes', and 0 for each 'no' response. The total score ranges from 0 to 26, where a higher score indicates a higher level of caregiver strain.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in caregiver Preparedness for Caregiving Scale
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

The Preparedness for Caregiving Scale is a caregiver self-rated instrument that consists of eight items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5 point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Score on Pittsburgh Rehabilitation Participation Scale (PRPS)
Lasso di tempo: weekly from 1- to 16-weeks post-discharge

The interventionist/transitional care manager will rate the patient and the caregiver on the Pittsburgh Rehabilitation Participation Scale (PRPS) to capture their level of engagement in Brain Injury Coping Skills (BICS) sessions. The PRPS is a clinician-rated instrument designed to assess a patient's participation in therapy. The PRPS will only be used for treatment arm participants.
weekly from 1- to 16-weeks post-discharge
Time spent caregiving and caregiving responsibilities
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

Time spent caregiving and caregiving responsibilities will be measured using 3 items created by the study team.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in Patient Activation Measure (PAM-10) for patients and caregivers.
Lasso di tempo: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

The Patient Activation measure will that assesses a patient's and caregiver's ability to manage their health and healthcare. Insignia Health's proprietary survey scoring algorithm produces a PAM Score along an empirical, interval-level scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation.
baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Demographics
Lasso di tempo: baseline (24-72 hours pre-discharge)

Age, sex, race/ethnicity, education, pre-injury occupation, insurance status, annual income
baseline (24-72 hours pre-discharge)
Clinical Factors
Lasso di tempo: baseline (24-72 hours pre-discharge)

TBI severity, length of stay, comorbidities (via chart review)
baseline (24-72 hours pre-discharge)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Duke University

Investigatori

  • Investigatore principale: Tolu O Oyesanya, PhD, RN, Duke University School of Nursing

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 gennaio 2024

Completamento primario (Stimato)

31 gennaio 2027

Completamento dello studio (Stimato)

31 gennaio 2027

Date di iscrizione allo studio

Primo inviato

14 aprile 2023

Primo inviato che soddisfa i criteri di controllo qualità

30 giugno 2023

Primo Inserito (Effettivo)

3 luglio 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Pro00112309

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

The proposed research will involve a sample of approximately N=500 individuals recruited from Duke University Hospital, located in Durham, NC. The final dataset will include self-reported demographic data, data collection measures, information recorded from study interventionists, and qualitative interview data (audio recordings and transcripts). We will be collecting identifying information. Although the final dataset will be de-identified, we believe there remains the possibility of deductive disclosure of participants with unusual characteristics. Thus, we will make data and associated documentation available to users only under a data-sharing agreement that provides for a commitment to: 1) using de-identified data only for research purposes and not to identify any individual participant; 2) securing the data using appropriate computer technology; and 3) destroying or returning the data after analyses are completed.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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