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A Prospective Observational Study Using the FAM-CAM

A legfontosabb adatok

Ki végzi
Shanghai Zhongshan Hospital
Hol
Kína1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
330 fő, tervezett
Kezdés
2026. aug. 1.
Várható befejezés
2027. júl. 31.
A vizsgálat típusa
Megfigyeléses
A regiszteradat frissítve
2026. augusztus 10.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak

A regiszter feltételei, szó szerint

Mind a 14 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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
  • 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

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Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat csoportja

  • 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.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Family Involvement in ICU Delirium Assessment: A Prospective Observational Study Using the FAM-CAM
A regiszteradat frissítve
2026. augusztus 10.