Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care
Enrolling by invitation · Not applicable
Conditions studied: Traumatic Brain Injury, Traumatic Brain Injury (TBI) Patients, TBI
In brief
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.
Key facts
- Study ID
- NCT07483528
- Run by
- Indiana University
- People needed
- 142
- Starts
- 2026-07-29
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- 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
You may not qualify if…
- non-community dwelling
Where it is running
- Indiana University School of Medicine — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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