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

NCT07483528 | Not Yet Recruiting

• 2 other identifiers: 3031590DPHF0017
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury; Traumatic Brain Injury (TBI) Patients; TBI

Outcome Measures

Primary Outcomes (2)

• Elder's Health Empowerment Scale (EHES)

  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.

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

• Patient Activation Measure (PAM)

  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.

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

Study Arms (2)

Patient Priorities Care (PPC)

EXPERIMENTAL

The PPC approach consists of one 30 minute session with a health professional to identify patient priorities.

Behavioral: Patient Priorities Care (PPC)

Resource Education

ACTIVE COMPARATOR

The Resource Education approach consists of one 30 minute session with a health professional about resources on living with brain injury.

Behavioral: Resource Education

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.

Patient Priorities Care (PPC)

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).

Resource Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• or more current chronic conditions (including chronic TBI)
• or more medications
• or more emergency department visits within the past 12 months
• 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

You may not qualify if:

• non-community dwelling

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Flora Hammond, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Overkamp

CONTACT

317-430-8669; moover@iu.edu

Rebecca Runkel

CONTACT

317-329-2217; rrunkel@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)