A Prospective Observational Study Using the FAM-CAM

NCT07694687 | Recruiting DMC

• 1 other identifier: B2026-150
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients in ICU; Family; Delirium in the Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Overall Agreement Among Family FAM-CAM, Nurse ICDSC, and Professional Research Staff CAM-ICU Assessments

  This outcome will measure the level of agreement among the three assessment methods in the same patient and within the same general time frame.During the ICU phase, paired assessment data will be created according to the pairing rules described for the primary outcome. The results of FAM-CAM, ICDSC, and CAM-ICU will be classified as either "positive" or "negative."Agreement will be evaluated using Cohen's kappa coefficient as the main measure. The overall agreement rate, positive agreement rate, and negative agreement rate will also be reported as additional measures, together with 95% confidence intervals.

  once daily between 3:30 PM and 4:30 PM

Secondary Outcomes (1)

• Effect of Older Age, Low Education Level, Language or Dialect Communication Barriers, and Family Members' Delirium Knowledge on Assessment Disagreement

  once daily between 3:30 PM and 4:30 PM

Study Arms (1)

Delirium Assessment Using FAM-CAM, ICDSC, and CAM-ICU

In this observational study, participants will not receive any study treatment or experimental intervention. The study procedures include daily delirium assessments and routine clinical data collection. Family members will complete one FAM-CAM assessment each day as soon as possible after the ICU visiting period ends. The bedside nurse will independently complete one ICDSC assessment during the same assessment period and record both the assessment result and the time of completion. A trained member of the research team will conduct one CAM-ICU assessment as the reference assessment, as close as practically possible to the FAM-CAM and ICDSC assessments. All three assessments will be completed within a 1-hour period, and the exact completion time of each assessment will be recorded. All three assessments will be conducted independently, and assessors will remain blinded to the results of the other assessments to minimize mutual influence and assessment bias.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients in ICU and their primary caregivers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Shining Cai, PhD

CONTACT

8618818260719; cai.shining@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU Head Nurse

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

CN (1)