Can family members spot delirium signs in ICU patients?
Official title: Family Involvement in ICU Delirium Assessment: A Prospective Observational Study Using the FAM-CAM
Run by Shanghai Zhongshan Hospital · NCT07694687 · Data updated 2026-11-12
Family members who know the patient well try a quick delirium check after visiting in the ICU, to see if their observations add information beyond routine nurse screenings.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 330 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07694687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) admitted to the ICU for at least 24 hours, with RASS ≥ -3 at enrollment, and with a willing, Mandarin-speaking family caregiver who has visited the patient.
✕Probably not a fit
Patients without available or willing family caregivers, or with deep coma/sedation, may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study asks whether family members can help identify delirium signs in adults in the ICU using the FAM-CAM assessment. Family members complete the brief delirium check after visits, while nurses perform standard ICDSC screenings as part of usual care. The study compares family reports with nurse assessments to determine if family input provides complementary information. Participants—both patients and their family caregivers—may participate for up to three days while in the ICU. The goal is to understand if incorporating family observations can improve delirium detection in the ICU setting.
Why it matters
Potential benefit: If successful, the approach could improve early detection of delirium by incorporating family observations into standard ICU screening.
How similar studies have gone: Previous work in ICU delirium has explored caregiver observations, with some studies suggesting added value, but results vary by setting and tool.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Shining Cai, PhD
- Email: cai.shining@zs-hospital.sh.cn
- Phone: 8618818260719
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.