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Family power: new study tests if loved ones can stop hospital delirium

NCT ID NCT05929703

Prevention Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study compares two approaches to prevent delirium in older adults during a hospital stay. One is standard hospital care (HELP), and the other adds daily support from family members (FAM-HELP). Researchers will track 1,900 patients aged 70 and older to see if family involvement reduces delirium and improves recovery.

What this could mean

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

Active substance
Family involvement in hospital care (FAM-HELP program)
What this could lead to
If it works, this could provide a simple, low-cost way to prevent delirium in older hospitalized patients by involving family members in daily care.
What could go wrong
This is a behavioral intervention, so results may vary across hospitals. The study is still recruiting, and the added benefit of family involvement over standard care may be small or hard to measure.

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 1,900 people

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

Started

Dec 2023

Expected to finish

Aug 2027

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

70 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: * Provision of informed consent * At least 70 years of age * Anticipated length of hospital stay at least 72 hours * Family member or care partner available to be on-site in the hospital * At least one delirium risk factor (e.g., cognitive or functional impairment, dehydration, vision or hearing impairment) * Evaluable cognitive function at baseline (i.e., ability to complete baseline cognitive function assessment) Exclusion Criteria: * Delirium on admission * Unable to communicate verbally (e.g., coma, mechanical ventilation) * Unable to participate fully in interventions (e.g., terminal condition, advanced dementia) * Staff safety concerns (e.g., violent behavior) * Cardiac or intracranial surgery (due to competing causes of delirium) * Active neurologic disease (as primary reason for admission)

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Caregiver Burden cognitive disorder Cognitive Dysfunction Patient Satisfaction delirium prevention target

As listed by the trial registrant

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

Aging Alzheimer disease Caregiver burden Delirium Family members Family support Implementation science Mild cognitive impairment Neurocognitive disorders Patient satisfaction

How to take part

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

  1. The places running it

    7 sites. 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

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • MaineHealth

    RECRUITING

    Portland, Maine, 04102, United States

  • Meriter Hospital

    RECRUITING

    Madison, Wisconsin, 53715, United States

  • Michigan Medicine

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Saddleback Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

More trials for these conditions

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