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Family Involvement in ICU Delirium Assessment: A Prospective Observational Study Using the FAM-CAM

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

⁃ 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.

Locations
Other Locations
China
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Shining Cai, PhD
cai.shining@zs-hospital.sh.cn
8618818260719
Time Frame
Start Date: 2026-08-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 330
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov