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Enrolling by Invitation

NCT Number: NCT07483528

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases TBI Trauma, Nervous System Traumatic Brain Injury (TBI) Patients Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • non-community dwelling

Treatment and study plan

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).

Primary outcomes

  1. Elder's Health Empowerment Scale (EHES)

    Time frame: collected at baseline and post-approach (approximately 7 - 21 days).

    A validated self-report instrument designed to measure health empowerment among older adults. The EHES evaluates multiple dimensions of empowerment, including self-control, self-efficacy, problems solving, psychosocial coping, support, motivation, and decision making. The 8-item scale is rated on a Likert-type scale, with higher scores indicating greater levels of health empowerment. The instrument has demonstrated good psychometric properties, including reliability and validity, making it suitable for use in research examining health behaviors, healthcare engagement, and outcomes among older adult populations. The EHES is particularly useful in studies investigating interventions aimed at promoting self-management, patient activation, or healthcare participation among elderly individuals, as it provides a quantifiable measure of empowerment-related constructs that are increasingly recognized as important factors in successful aging and chronic disease management.

  2. Patient Activation Measure (PAM)

    Time frame: collected at baseline and post-approach (approximately 7 - 21 days).

    a 10-item measure of how informed and involved individuals are in their healthcare. It uses a 0-100 scale, segmenting activation into four levels, with higher scores indicating greater engagement. A unidimensional, interval-level, Guttman-like scale, PAM has strong psychometric properties and predicts key health behaviors, outcomes, and costs (obtaining screenings, immunizations, healthy diet, regular exercise, self-management, health-information seeking, better health outcomes and lower utilization and costs). PAM scores improve with supports and interventions and the PAM is a reliable and valid instrument for research in patients with neuro-logical conditions.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: 2BeHealthy

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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