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NCT Number: NCT07694687

A Prospective Observational Study Using the FAM-CAM

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.

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Key information

Conditions

Patients in ICU Delirium in the Intensive Care Unit Family

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Lian Zhu, PhD

CONTACT

[email protected]

Shining Cai, PhD

CONTACT

[email protected]

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    This outcome measure will evaluate the effect of older age, defined as age 65 years or older; low education level, defined as primary school education or below; language or dialect communication barriers, recorded as present or absent; and family members' delirium knowledge questionnaire scores on disagreement among delirium assessments.

    Assessment disagreement is defined as inconsistent delirium classification among the family-completed FAM-CAM, nurse-completed ICDSC, and CAM-ICU completed by trained research staff in the same patient and within a similar assessment time frame.

    The study will compare the proportion of disagreement events across different subgroups and will use regression analysis to evaluate the strength of association between these factors and assessment disagreement. Results will be reported as odds ratios with 95% confidence intervals.

Study contacts

Contact information is provided by the study sponsor or research team.

Shining Cai, PhD

CONTACT

[email protected]

8618818260719

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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