Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care (NCT07483528) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care
United States142 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* community dwelling adult (\>18 years at enrollment)
* ≥1-year post-TBI of any severity 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
Exclusion Criteria:
* non-community dwelling
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Elder's Health Empowerment Scale (EHES)
Timeframe: collected at baseline and post-approach (approximately 7 - 21 days).
2
Patient Activation Measure (PAM)
Timeframe: collected at baseline and post-approach (approximately 7 - 21 days).