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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07483528
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patient Priorities Care (PPC) — BEHAVIORAL
    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 Education — BEHAVIORAL
    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 Details

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 Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Patient Priorities Care (PPC)
    The PPC approach consists of one 30 minute session with a health professional to identify patient priorities.
  • Active Comparator: Resource Education
    The Resource Education approach consists of one 30 minute session with a health professional about resources on living with brain injury.

Primary Outcome Measure

Elder's Health Empowerment Scale (EHES) [ Time Frame: collected at baseline and post-approach (approximately 7 - 21 days). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University School of MedicineIndianapolisIndiana46202
Flora Hammond, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University School of Medicine· Indianapolis, IN

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