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

Investigating Approaches to Improve Health Management in Chronic Traumatic Brain Injury

F
Flora Hammond, MD

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase N/A
115 participants needed
1 Location

Brief description of study

To better understand the efficacy of a person-centered approach to enhance health empowerment/self-efficacy and engagement among persons with chronic Traumatic Brain Injury (TBI).

THIS STUDY IS ENROLLING BY INVITATION ONLY - Brain injury physician clinics across the US will refer potential participants. Brain injury physicians recruiting for this study are a part of the PI’s network of professional contacts. To refer a patient, the brain injury physician will facilitate recruitment by briefly discussing the study with their patient, which may include sharing recruitment materials. Only patients the physician believes to be eligible will receive recruitment materials. 

Detailed description of study

The study uses mixed methods including double-masked (neither participants nor research-ers/assessors know which approach participants are receiving), parallel-group randomized, con-trolled 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 ap-proach (control). Additionally, qualitative interviews will be conducted with selected partici-pants 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.
 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Traumatic brain injury, TBI
  • Age: 18 years or above
  • Gender: All

Aim 1: Inclusion Criteria

Community-dwelling, adult (≥ 18 at enrollment); ≥1-year post-TBI of any severity based on The Ohio State University-TBI Identification Method39 (OSU-TBI-ID); followed by a brain injury physician for TBI care who refers them to the study; must have sufficient compre-hension, communication, sensorimotor function, and English proficiency (due to outcome measures not being validated in languages other than English)  for 1:1 activities and assess-ments (per research assistant confirmed during the consent process and baseline assessment); must provide informed consent and have webcam and Internet access for assessments and ap-proach. 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
•    Complete baseline data prior to randomization
 

Aim 2: Inclusion Criteria

  • For Aim 2, the participant must have been randomized to the PPC approach in Aim 1.
     

The purpose of this study is to investigate different ways to help people with chronic Traumatic Brain Injury (TBI) manage their healthcare. Traumatic Brain Injury, or TBI, is a condition where a person has suffered a significant injury to the brain, often causing long-term effects. This study compares two approaches: a person-centered approach called Patient Priorities Care (PPC) and a resource education approach. The goal is to see which approach better enhances health empowerment and engagement among participants.

Participants in the study will be randomly assigned to one of the two approaches. In the PPC approach, participants will receive care focused on their personal health priorities, while the control group will receive standard resource education. The study is double-masked, meaning neither the participants nor the researchers know which approach the participants are receiving. Additionally, some participants will be interviewed to understand their experiences with the PPC approach.

  • Who can participate: Adults aged 18 or older who have had a Traumatic Brain Injury for at least one year can participate. They must be referred by a brain injury physician, have internet access, and meet specific health criteria.
  • Study details: Participants will be involved in activities and assessments to evaluate their health management. Interviews will also be conducted with some participants to gather more insights.
Updated on 15 Jul 2026. Study ID: PHMR-NIDILRR-2BEHEALTHY, 30315
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only