Traumatic Brain Injury2BeHealthyNCT07483528
Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care
A study testing Patient Priorities Care (PPC) and Resource Education in people with Traumatic Brain Injury and Traumatic Brain Injury (TBI) Patients, run by Indiana University at 1 site in United States.
Trial summary
The goal of this double-masked, randomized control trial is to learn about the potential benefits of two different strategies at helping people with traumatic brain injury who see a brain injury physician be more engaged in their healthcare and feel more confident in managing their health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Traumatic Brain Injury (TBI) Patients, TBI
- What is being tested?
- Patient Priorities Care (PPC) and Resource Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2026to Aug 2028
- 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
Who may be able to join
- community dwelling adult (>18 years at enrollment)
- ≥1-year post-TBI that resulted in loss of consciousness based on The Ohio State University-TBI Identification Method
- followed by a brain injury physician for TBI care who refers them to the study
- must have sufficient comprehension, communication, sensorimotor function, and English proficiency (due to outcome measures not being validated in languages other than English)
- must provide informed consent and have webcam and Internet access for assessments and approach
- Additionally, meet 1 or more of the following criteria:
Show all 11Show fewer
- 2 or more current chronic conditions (including chronic TBI)
- 5 or more medications
- 3 or more emergency department visits within the past 12 months
- 1 or more hospital admissions within the past 12 months
- Under care of 2 or more specialists (non-primary care), including physicians, midlevel providers, therapists, mental health professionals) with visits with these providers in the past 12 months
Who cannot join
- non-community dwelling
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
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
The goal of this double-masked, randomized control trial is to learn about the potential benefits of two different strategies at helping people with traumatic brain injury who see a brain injury physician be more engaged in their healthcare and feel more confident in managing their health.
The main questions it aims to answer are:
Read more
- When comparing the two strategies, which will result in high participant-reported health empowerment assessed approximately 7 - 21 days of completing the approach?
- When comparing the two strategies, which will result in high participant-reported health engagement assessed approximately 7 - 21 days of completing the approach?
Participants will:
- complete baseline assessments about their health, daily activities, and their attitudes about healthcare and their treatment. These will be done over the phone and/or online survey.
- have one virtual session with a health professional to discuss their health and wellness.
- 7-21 days after the session with a health professional, participants will complete an online survey about their attitudes about healthcare and their treatment.
- Some participants may be invited to complete an additional interview about their study participation around 3 months after their session with the health professional.
Read the detailed description
Phase II trial of PPC for persons with TBI versus resource education control; and qualitative input from selected participants. The study uses mixed methods including double-masked (neither participants nor researchers/assessors know which approach participants are receiving), parallel-group randomized, controlled trial (RCT) using a person-centered approach, Patient Priorities Care (PPC) to enhance health empowerment/self-efficacy and engagement, as compared to a resource education approach (control). Additionally, qualitative interviews will be conducted with selected participants to assess the experience (impact, satisfaction, barriers, and facilitators) of participating in the PPC approach among select adults with chronic TBI randomized to that approach arm.
- Being tested
- Patient Priorities Care (PPC), Resource Education
- 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.
Patient Priorities Care (PPC)Behavioural
A health professional will conduct a 30-minute interview with the participant to: identify what matters most to them (their values); establish realistic, specific, and actionable healthcare goals they want to accomplish; identify the symptom or problem preventing the participant from reaching their goals; and establish one goal (the one thing) they want to focus on achieving with their healthcare providers that is aligned with the participant's values.
Resource EducationBehavioural
A health professional will conduct a 30-minute education session with the participant about resources on living with brain injury available on the Brain Injury Association of America website (https://biausa.org/). The interaction will exclude PPC-specific elements (health priorities identification and care alignment).
| Study group | Role | What they receive |
|---|---|---|
| Patient Priorities Care (PPC) | Experimental | The PPC approach consists of one 30 minute session with a health professional to identify patient priorities. Receives: Behavioral: Patient Priorities Care (PPC) |
| Resource Education | Active comparator | The Resource Education approach consists of one 30 minute session with a health professional about resources on living with brain injury. Receives: Behavioral: Resource Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elder's Health Empowerment Scale (EHES)
A validated self-report instrument designed to measure health empowerment among older adults. The EHES evaluates multiple dimensions of empowerment, including self-control, self-efficacy, problems solving, psychosocial coping, support, motivation, and decision making. The 8-item scale is rated on a Likert-type scale, with higher scores indicating greater levels of health empowerment. The instrument has demonstrated good psychometric properties, including reliability and validity, making it suitable for use in research examining health behaviors, healthcare engagement, and outcomes among older adult populations. The EHES is particularly useful in studies investigating interventions aimed at promoting self-management, patient activation, or healthcare participation among elderly individuals, as it provides a quantifiable measure of empowerment-related constructs that are increasingly recognized as important factors in successful aging and chronic disease management.
Measured: collected at baseline and post-approach (approximately 7 - 21 days).
Patient Activation Measure (PAM)
a 10-item measure of how informed and involved individuals are in their healthcare. It uses a 0-100 scale, segmenting activation into four levels, with higher scores indicating greater engagement. A unidimensional, interval-level, Guttman-like scale, PAM has strong psychometric properties and predicts key health behaviors, outcomes, and costs (obtaining screenings, immunizations, healthy diet, regular exercise, self-management, health-information seeking, better health outcomes and lower utilization and costs). PAM scores improve with supports and interventions and the PAM is a reliable and valid instrument for research in patients with neuro-logical conditions.
Measured: collected at baseline and post-approach (approximately 7 - 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start29 Jul 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flora Hammond, Indiana University
- Investigators
- Flora Hammond, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483528
- Sponsor's protocol ID
- 30315
- Other IDs
- 90DPHF0017
- Acronym
- 2BeHealthy
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care
- ClinicalTrials.gov ID
- NCT07483528
- Acronym / sponsor ID
- 2BeHealthy / 30315
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 19 Mar 2026 (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.
The goal of this double-masked, randomized control trial is to learn about the potential benefits of two different strategies at helping people with traumatic brain injury who see a brain injury physician be more engaged in their healthcare and feel more confident in managing their health.
The main questions it aims to answer are:
- When comparing the two strategies, which will result in high participant-reported health empowerment assessed approximately 7 - 21 days of completing the approach?
- When comparing the two strategies, which will result in high participant-reported health engagement assessed approximately 7 - 21 days of completing the approach?
Participants will:
- complete baseline assessments about their health, daily activities, and their attitudes about healthcare and their treatment. These will be done over the phone and/or online survey.
- have one virtual session with a health professional to discuss their health and wellness.
- 7-21 days after the session with a health professional, participants will complete an online survey about their attitudes about healthcare and their treatment.
- Some participants may be invited to complete an additional interview about their study participation around 3 months after their session with the health professional.
Detailed description
Phase II trial of PPC for persons with TBI versus resource education control; and qualitative input from selected participants. The study uses mixed methods including double-masked (neither participants nor researchers/assessors know which approach participants are receiving), parallel-group randomized, controlled trial (RCT) using a person-centered approach, Patient Priorities Care (PPC) to enhance health empowerment/self-efficacy and engagement, as compared to a resource education approach (control). Additionally, qualitative interviews will be conducted with selected participants to assess the experience (impact, satisfaction, barriers, and facilitators) of participating in the PPC approach among select adults with chronic TBI randomized to that approach arm.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Priorities Care (PPC) | Experimental | Behavioral: Patient Priorities Care (PPC)The PPC approach consists of one 30 minute session with a health professional to identify patient priorities. |
| Resource Education | Active comparator | Behavioral: Resource EducationThe Resource Education approach consists of one 30 minute session with a health professional about resources on living with brain injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- community dwelling adult (>18 years at enrollment)
- ≥1-year post-TBI that resulted in loss of consciousness based on The Ohio State University-TBI Identification Method
- followed by a brain injury physician for TBI care who refers them to the study
- must have sufficient comprehension, communication, sensorimotor function, and English proficiency (due to outcome measures not being validated in languages other than English)
- must provide informed consent and have webcam and Internet access for assessments and approach
Key exclusion criteria (1 listed)
- non-community dwelling
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 |
|---|---|---|
| Patient Priorities Care (PPC)A health professional will conduct a 30-minute interview with the participant to: identify what matters most to them (their values); establish realistic, specific, and actionable healthcare goals they want to accomplish; identify the symptom or problem preventing the participant from reaching their goals; and establish one goal (the one thing) they want to focus on achieving with their healthcare providers that is aligned with the participant's values. | Behavioural | Patient Priorities Care (PPC) |
| Resource EducationA health professional will conduct a 30-minute education session with the participant about resources on living with brain injury available on the Brain Injury Association of America website (https://biausa.org/). The interaction will exclude PPC-specific elements (health priorities identification and care alignment). | Behavioural | Resource Education |
Primary outcome
Elder's Health Empowerment Scale (EHES)
Time frame: collected at baseline and post-approach (approximately 7 - 21 days).
A validated self-report instrument designed to measure health empowerment among older adults. The EHES evaluates multiple dimensions of empowerment, including self-control, self-efficacy, problems solving, psychosocial coping, support, motivation, and decision making. The 8-item scale is rated on a Likert-type scale, with higher scores indicating greater levels of health empowerment. The instrument has demonstrated good psychometric properties, including reliability and validity, making it suitable for use in research examining health behaviors, healthcare engagement, and outcomes among older adult populations. The EHES is particularly useful in studies investigating interventions aimed at promoting self-management, patient activation, or healthcare participation among elderly individuals, as it provides a quantifiable measure of empowerment-related constructs that are increasingly recognized as important factors in successful aging and chronic disease management.
Patient Activation Measure (PAM)
Time frame: collected at baseline and post-approach (approximately 7 - 21 days).
a 10-item measure of how informed and involved individuals are in their healthcare. It uses a 0-100 scale, segmenting activation into four levels, with higher scores indicating greater engagement. A unidimensional, interval-level, Guttman-like scale, PAM has strong psychometric properties and predicts key health behaviors, outcomes, and costs (obtaining screenings, immunizations, healthy diet, regular exercise, self-management, health-information seeking, better health outcomes and lower utilization and costs). PAM scores improve with supports and interventions and the PAM is a reliable and valid instrument for research in patients with neuro-logical conditions.
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 6 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
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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.
Flora Hammond, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Priorities Care (PPC) and Resource Education in people with Traumatic Brain Injury and Traumatic Brain Injury (TBI) Patients, run by Indiana 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?
The sponsor lists 11 inclusion and 1 exclusion criteria. 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 6 Aug 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. 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?
Elder's Health Empowerment Scale (EHES) (time frame: collected at baseline and post-approach (approximately 7 - 21 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.