Traumatic Brain InjuryNCT05929833
BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)
A study testing BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) in people with Traumatic Brain Injury, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- 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]
- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: A Randomized Controlled Trial of BETTER, A Transitional Care Intervention, for Patients With Traumatic Brain Injury and Their Families
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.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery), Usual Care
- Keywords
- transitional care, patients, family caregivers
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery)Behavioural
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 CareOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient physical functioning (Neuro-QOL, Upper & Lower extremity functioning)
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.
Measured: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient sleep disturbance (NeuroQOL Sleep Disturbance, short-form)
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.
Measured: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient TBI-related symptoms (Rivermead Post-concussion questionnaire)
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
Measured: 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)]
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
Measured: 8-, 16-, and 24-weeks post-discharge
Change in patient process of care transition [Care Transitions Measure-3 (CTM-3)]
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
Measured: 8-, 16-, and 24-weeks post-discharge
Change in patient and caregiver difficulty accessing services [Service Obstacles Scale (SOS)]
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
Measured: 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)
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.
Measured: 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]
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.
Measured: 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)]
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.
Measured: 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
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.
Measured: 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)
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
Measured: 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)
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.
Measured: baseline (24-72 hours pre-discharge)
Number and type of healthcare services utilized
Measured by patient and/or caregiver proxy report of patient transitional health care utilization, using a survey developed by the team.
Measured: 8-, 16-, and 24-weeks post-discharge
Change in caregiver Modified Caregiver Strain Index (MCSI)
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.
Measured: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in caregiver Preparedness for Caregiving Scale
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.
Measured: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Score on Pittsburgh Rehabilitation Participation Scale (PRPS)
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.
Measured: weekly from 1- to 16-weeks post-discharge
Time spent caregiving and caregiving responsibilities
Time spent caregiving and caregiving responsibilities will be measured using 3 items created by the study team.
Measured: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in Patient Activation Measure (PAM-10) for patients and caregivers.
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.
Measured: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start26 Jan 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tolu O Oyesanya, PhD, RN, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929833
- Sponsor's protocol ID
- Pro00112309
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38394279
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of BETTER, A Transitional Care Intervention, for Patients With Traumatic Brain Injury and Their Families
- ClinicalTrials.gov ID
- NCT05929833
- Acronym / sponsor ID
- Pro00112309
- Conditions
- Traumatic Brain Injury
- Keywords
- transitional care, patients, family caregivers
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BETTER TBI (Traumatic Brain Injury) Transitional Care Intervention | Experimental | Behavioral: BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery)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. |
| Usual Care | Placebo comparator | Other: Usual CareIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | BETTER TBI (Traumatic Brain Injury) Transitional Care Intervention |
| Usual CareUsual 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 |
Primary outcome
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
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.
19 secondary outcomes
Change in patient cognitive function (Neuro-QOL, Cognitive functioning)
Time frame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient physical functioning (Neuro-QOL, Upper & Lower extremity functioning)
Time frame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient sleep disturbance (NeuroQOL Sleep Disturbance, short-form)
Time frame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in patient TBI-related symptoms (Rivermead Post-concussion questionnaire)
Time frame: 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)]
Time frame: 8-, 16-, and 24-weeks post-discharge
Change in patient process of care transition [Care Transitions Measure-3 (CTM-3)]
Time frame: 8-, 16-, and 24-weeks post-discharge
Change in patient and caregiver difficulty accessing services [Service Obstacles Scale (SOS)]
Time frame: 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)
Time frame: 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]
Time frame: 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)]
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: baseline (24-72 hours pre-discharge)
Number and type of healthcare services utilized
Time frame: 8-, 16-, and 24-weeks post-discharge
Change in caregiver Modified Caregiver Strain Index (MCSI)
Time frame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in caregiver Preparedness for Caregiving Scale
Time frame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Score on Pittsburgh Rehabilitation Participation Scale (PRPS)
Time frame: weekly from 1- to 16-weeks post-discharge
Time spent caregiving and caregiving responsibilities
Time frame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Change in Patient Activation Measure (PAM-10) for patients and caregivers.
Time frame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 38394279Oyesanya 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.
- Efficacy of BETTER transitional care intervention for diverse patients with traumatic brain injury and their families: Study protocol of a randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tolu O Oyesanya, PhD, RN principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) in people with Traumatic Brain Injury, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.