Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care
NCT07483528 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142
Last updated 2026-03-19
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.
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.
Conditions
- Traumatic Brain Injury
- Traumatic Brain Injury (TBI) Patients
- TBI
Interventions
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
Resource Education
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).
Sponsors & Collaborators
-
Indiana University
lead OTHER
Principal Investigators
-
Flora Hammond, MD · Indiana University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-08-31
- Completion
- 2028-08-31
Countries
- United States
Study Locations
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