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New study aims to ease burden on families of brain injury patients

NCT ID NCT07590726

Symptom relief Sponsor: Rigshospitalet, Denmark 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 This study
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a stepped-care model to support relatives of people with acquired brain injury or malignant brain tumor. The model offers basic support to all, with extra help for those who need it, based on screening. Researchers will measure changes in caregiver burden and well-being in 160 relatives, comparing the new approach to usual care.

What this could mean

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

Active substance
stepped-care support model (structured conversations, screening, and coordination)
What this could lead to
If it works, this could provide a practical way to reduce stress and burden for family caregivers of brain injury or tumor patients.
What could go wrong
This is a small, early-stage study (160 participants) testing a support model, not a medical treatment. Results may not apply to all caregivers or settings.

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 160 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

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 * Primary relative of an adult diagnosed with acquired brain injury (ABI) or malignant brain tumor (MBT), admitted to a participating hospital department. * Formally identified as the primary relative by the patient. * Aged ≥18 years. * Ability to read, understand, and complete questionnaires in Danish. Exclusion Criteria * Insufficient proficiency in Danish to complete questionnaires and participate in structured conversations. * Concurrent participation in another interventional study with a similar aim that may interfere with the present study.

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Conditions

The condition(s) this trial relates to.

brain cancer Brain Injuries, Traumatic brain injury Caregiver Burden Communication glioblastoma Margins of Excision neoplasm nervous system cancer Neurologic Manifestations stroke disorder traumatic brain injury

As listed by the trial registrant

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

Brain (nervous system) cancers Brain injuries, acute Brain tumor adult Glioblastom who grade 4 Glioblastoma (GBM) Stroke Traumatic brain injuries

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Rigshospitalet

    Copenhagen, Ø, 2100, Denmark

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