Resource Education vs PPC for Traumatic Brain Injury

(2BeHealthy Trial)

MO
RR
Overseen ByRebecca Runkel
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

FH

Flora Hammond, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

Inclusion Criteria

≥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)
See 3 more

Exclusion Criteria

Non-community dwelling

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete baseline assessments about their health, daily activities, and attitudes about healthcare and treatment over the phone and/or online survey

1 week
1 virtual visit

Intervention

Participants have one virtual session with a health professional to discuss their health and wellness

1 day
1 virtual session

Post-Intervention Assessment

Participants complete an online survey about their attitudes about healthcare and treatment 7-21 days after the session with a health professional

2-3 weeks

Follow-up

Some participants may be invited to complete an additional interview about their study participation around 3 months after their session with the health professional

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Patient Priorities Care (PPC)
  • Resource Education

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Patient Priorities Care (PPC)Experimental Treatment1 Intervention
Group II: Resource EducationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+