A Prospective Observational Study Using the FAM-CAM

NCT07694687 | Not Yet Recruiting DMC

• 1 other identifier: B2026-150
• Study Type: observational
• Target: 330
• Locations: 0 countries
• Sites: N/A

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, or ICU. 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 4:00 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 4:00 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, usually between 15:30 and 16:00. The family member will fill out the assessment form, and study staff will check the form for completeness and accuracy and record the time the assessment is completed. Nurses will complete one ICDSC assessment each day as soon as possible after the ICU visiting period ends, usually between 15:30 and 16:00. The nurse will record the assessment result and the time the assessment is completed. Trained research staff will complete one CAM-ICU assessment within a prespecified time window, close to the time of the family FAM-CAM assessment and the nurse ICDSC assessment. The CAM-ICU result and assessment time will be recorded.

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

You may qualify if:

• Patients:
• Age 18 years or older.
• Admitted to the ICU for at least 24 hours.
• Richmond Agitation-Sedation Scale (RASS) score ≥ -3.
• The patient or family member provides informed consent and voluntarily agrees to participate.
• Family Members:
• Age 18 years or older.
• The patient's primary caregiver or main contact person, and familiar with the patient's usual cognition and behavior.
• The main visiting family member during the patient's ICU stay, with at least one ICU visit.
• Able to understand Chinese questionnaires.
• Provides informed consent and voluntarily agrees 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.
• Previous confirmed diagnosis of dementia, severe psychiatric disorder, or organic neurological disease.
• Language impairment or hearing impairment that prevents basic communication.
• Family Members:
• Significant visual, hearing, or cognitive problems that prevent completion of the FAM-CAM assessment.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

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: July 10, 2026

Record last verified: 2026-07