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Family eyes on ICU delirium: could loved ones spot what nurses miss?

NCT ID NCT07694687

Knowledge-focused Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study looks at whether family members can help identify delirium—a sudden confusion that can occur during serious illness—in adult ICU patients. Family members will complete a short assessment after visiting, while nurses continue their usual screening. Researchers will compare the two to see if family observations add valuable information.

What this could mean

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

What this could lead to
If family observations prove reliable, this could lead to better delirium detection in ICUs, improving patient care.
What could go wrong
This is an observational study, not a treatment trial. Family assessments may not always match professional evaluations, and results may not apply to all ICU 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.

Participants

About 330 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 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.

Who is studied

patients in ICU and their primary caregivers

Ages

18 years and older

Sex

Anyone

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 Patients: * Aged 18 years or older. * Admitted to the ICU for at least 24 hours. * Richmond Agitation-Sedation Scale (RASS) score ≥ -3 at the time of enrollment. * Provided written informed consent to participate. When patients were unable to provide consent, consent was obtained from their legal surrogates. Family Members: * Aged 18 years or older. * Identified as the patient's primary family caregiver. * Had visited the patient in the ICU at least once. * Were able to understand and communicate in Mandarin. * Provided written informed consent and voluntarily agreed to participate. Exclusion Criteria Patients: * Persistent coma or deep sedation throughout the ICU stay, defined as Glasgow Coma Scale (GCS) score ≤ 8 or RASS score of -4 or -5. * A previously confirmed diagnosis of dementia, a severe psychiatric disorder, or an organic neurological disease. * Severe hearing impairment that prevented effective communication or study participation. Family Members: -Significant visual, hearing, or cognitive problems that prevented them from understanding the study procedures or completing the study assessments.

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Conditions

The condition(s) this trial relates to.

delirium

As listed by the trial registrant

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

Delirium in the intensive care unit FAMILY Patients in icu

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

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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