NCT07483528

Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Traumatic Brain Injury
• Traumatic Brain Injury (TBI) Patients
• TBI

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States