Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
non-community dwelling
Trial design
Design model
Parallel
Treatments tested in this trial
Patient Priorities Care (PPC)
BehavioralA 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
BehavioralA 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).
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: Patient Priorities Care (PPC)Experimental treatment 1 intervention
Group B: Resource EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
collected at baseline and post-approach (approximately 7 - 21 days).2
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.
Time frame
collected at baseline and post-approach (approximately 7 - 21 days).Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: