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Enrolling By Invitation
NCT07483528
Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care
Conditions: Traumatic Brain Injury, Traumatic Brain Injury (TBI) Patients, TBI
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 142
Sponsor: Indiana University
Location: Indiana University School of Medicine Indianapolis Indiana
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07483528). StuddyBuddy aggregates publicly available trial information.