[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646232":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":38,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":10,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":10,"overallStatus":21,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Delirium Assessment Using FAM-CAM, ICDSC, and CAM-ICU",null,"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.\n\nFamily members will complete one FAM-CAM assessment each day as soon as possible after the ICU visiting period ends.\n\nThe bedside nurse will independently complete one ICDSC assessment during the same assessment period and record both the assessment result and the time of completion.\n\nA 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.\n\nAll 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.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Shining Cai, PhD","CONTACT","8618818260719","cai.shining@zs-hospital.sh.cn",[19],{"facility":20,"status":21,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Zhongshan Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":28,"coordinates":29},"Point",[30,31],121.45806,31.22222,{"lat":31,"lon":30},[34,35],{"name":14,"role":15,"phone":10,"phoneExt":10,"email":17},{"name":36,"role":15,"phone":10,"phoneExt":10,"email":37},"Lian Zhu, PhD","zhu.lian1@zs-hospital.sh.cn",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Shining Cai","ICU Head Nurse","100646232","a-prospective-observational-study-using-the-fam-cam-100646232",false,"NCT07694687","A Prospective Observational Study Using the FAM-CAM","Family Involvement in ICU Delirium Assessment: A Prospective Observational Study Using the FAM-CAM","Inclusion Criteria\n\nPatients:\n\n* Aged 18 years or older.\n* Admitted to the ICU for at least 24 hours.\n* Richmond Agitation-Sedation Scale (RASS) score ≥ -3 at the time of enrollment.\n* Provided written informed consent to participate. When patients were unable to provide consent, consent was obtained from their legal surrogates.\n\nFamily Members:\n\n* Aged 18 years or older.\n* Identified as the patient's primary family caregiver.\n* Had visited the patient in the ICU at least once.\n* Were able to understand and communicate in Mandarin.\n* Provided written informed consent and voluntarily agreed to participate.\n\nExclusion Criteria\n\nPatients:\n\n* Persistent coma or deep sedation throughout the ICU stay, defined as Glasgow Coma Scale (GCS) score ≤ 8 or RASS score of -4 or -5.\n* A previously confirmed diagnosis of dementia, a severe psychiatric disorder, or an organic neurological disease.\n* Severe hearing impairment that prevented effective communication or study participation.\n\nFamily Members:\n\n-Significant visual, hearing, or cognitive problems that prevented them from understanding the study procedures or completing the study assessments.","ALL","18 Years",{"count":52,"type":53},330,"ESTIMATED","OBSERVATIONAL","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.\n\nThe main question it aims to answer is:\n\nCan 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.\n\nFamily members may complete the assessment for up to 3 days while the patient is in the ICU.",[57,58,59],"Patients in ICU","Delirium in the Intensive Care Unit","Family","2026-08-06",{"date":62,"type":63},"2026-08-10","ACTUAL",{"date":65,"type":53},"2026-08-01",{"date":67,"type":53},"2027-07-31",{"name":5,"class":6},1]