NCT07694687 A Prospective Observational Study Using the FAM-CAM
| NCT ID | NCT07694687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Patients in ICU |
| Study Type | OBSERVATIONAL |
| Enrollment | 330 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 330 participants in total. It began in 2026-08-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn whether family members can help identify signs of delirium in adult patients who are staying in the intensive care unit. Delirium is a sudden change in attention, thinking, or awareness that can happen during serious illness. The main question it aims to answer is: Can family members notice possible signs of delirium that may not be found during routine ICU delirium screening? Participants will receive their usual medical care. Family members who know the patient well will complete a short delirium assessment called the FAM-CAM after visiting the patient. Nurses will continue to perform routine ICU delirium screening using the ICDSC as part of usual care. The study team will compare the family member's assessment with the nurse's routine assessment to see whether family observations provide additional helpful information. Family members may complete the assessment for up to 3 days while the patient is in the ICU.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07694687 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patients in ICU. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07694687 currently recruiting?
Yes, NCT07694687 is actively recruiting participants. Contact the research team at cai.shining@zs-hospital.sh.cn for enrollment information.
Where is the NCT07694687 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07694687 clinical trial?
NCT07694687 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 330 participants.