Patients in ICUNCT07694687
A Prospective Observational Study Using the FAM-CAM
An observational study of Patients in ICU and Delirium in the Intensive Care Unit, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients in ICU, Delirium in the Intensive Care Unit, Family
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients in ICU and their primary caregivers
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Shining Cai, PhD, cai.shining@zs-hospital.sh.cn
Lian Zhu, PhD, zhu.lian1@zs-hospital.sh.cn
About this study
Official title: Family Involvement in ICU Delirium Assessment: 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:
Read more
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, Delirium in the Intensive Care Unit, Family
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: once daily between 3:30 PM and 4:30 PM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients in ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shining Cai, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694687
- Sponsor's protocol ID
- B2026-150
- Status last verified
- Aug 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Involvement in ICU Delirium Assessment: A Prospective Observational Study Using the FAM-CAM
- ClinicalTrials.gov ID
- NCT07694687
- Acronym / sponsor ID
- B2026-150
- Conditions
- Patients in ICU, Delirium in the Intensive Care Unit, Family
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients in ICU and their primary caregivers
Key inclusion criteria (11 listed)
- 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.
- Aged 18 years or older.
Key exclusion criteria (6 listed)
- 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.
- -Significant visual, hearing, or cognitive problems that prevented them from understanding the study procedures or completing the study assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients in ICU and Delirium in the Intensive Care Unit, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shining Cai, PhD (8618818260719, cai.shining@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.