Family eyes on ICU delirium: could loved ones spot what nurses miss?
NCT ID NCT07694687
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
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About 330 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Zhongshan Hospital, Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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Other studies related to the condition(s) this trial covers.
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