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New study tests simple conversations to empower brain injury patients

NCT ID NCT07483528

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 4 times

Summary

This study compares two approaches to help people with chronic traumatic brain injury (TBI) become more engaged and confident in managing their health. One approach focuses on what matters most to the patient, while the other provides general health education. The trial will involve 142 adults who are at least one year post-TBI and see a brain injury doctor. Participants will have a single virtual session with a health professional and complete surveys to measure their health empowerment and engagement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Patient Priorities Care (PPC) and Resource Education (both behavioral interventions)
What this could lead to
If successful, this could show that a simple, values-based conversation helps people with TBI feel more in control of their health and more involved in their care.
What could go wrong
This is a small, early-stage study (142 people) comparing two behavioral approaches, not testing a drug or cure. Results may not apply to all TBI patients, and the benefits may be modest or short-lived.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic transient ischemic attack traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

TBI Traumatic brain injury Traumatic brain injury (TBI) patients

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.