A Prospective Observational Study Using the FAM-CAM
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, 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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria
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.
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.
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Agreement Among Family FAM-CAM, Nurse ICDSC, and Professional Research Staff CAM-ICU Assessments
Časové okno: once daily between 3:30 PM and 4:00 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.
|
once daily between 3:30 PM and 4:00 PM
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Effect of Older Age, Low Education Level, Language or Dialect Communication Barriers, and Family Members' Delirium Knowledge on Assessment Disagreement
Časové okno: once daily between 3:30 PM and 4:00 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. |
once daily between 3:30 PM and 4:00 PM
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- B2026-150
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Pacienti na JIP
-
Beni-Suef UniversityZatím nenabíráme
-
Universitair Ziekenhuis BrusselSociété des Produits Nestlé (SPN)NáborPacienti po ICU se plně vstupujíBelgie
-
Asan Medical CenterSeoul National University Bundang Hospital; EverEx Inc.NáborICU Acquired Weakness (ICUAW)Jižní Korea
-
Universitätsklinikum Hamburg-EppendorfDokončenoHodnota virtuální pitvy pro kontrolu kvality na ICUNěmecko
-
Asan Medical CenterEverEx Inc.DokončenoICU Acquired Weakness (ICUAW)Jižní Korea
-
Uşak UniversityDokončenoEmoční stavy | Terapeutická komunikace na dětské ICU | Dětská emoční pohoda na JIPKrocan
-
Samsung Medical CenterMinistry of Health and WelfareZápis na pozvánkuZávažné onemocnění | Skupinové studie | ICU Acquired Weakness (ICUAW)Korejská republika
-
University of AthensNeznámýKritická nemoc polyneuromyopatie (CIPNM) | ICU Acquired Weakness (ICUAW)Řecko
-
Meshalkin Research Institute of Pathology of CirculationZatím nenabírámepevnostní vlastnosti aorty in vivo | pevnostní vlastnosti aorty in vitro | Regresní model pevnostních vlastností aorty in vitro a in vitroRuská Federace
-
Tri-Service General HospitalZápis na pozvánku