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Translation, cross-cultural Adaptation and Validation of the Family Confusion Assessment Method into German for the Detection of Delirium in Critically Ill Patients

Translation, cross-cultural Adaptation and Validation of the Family Confusion Assessment Method into German for the Detection of Delirium in Critically Ill Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00016930
Enrollment
50
Registered
2019-03-15
Start date
2020-01-23
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F05

Interventions

Group 1: Verification of concurrent validity is performed in the intensive care unit. Subjects (Test persons) are recruited on the basis of defined inclusion and exclusion criteria. For testing the co

Sponsors

Universitätsklinikum Regensburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Relatives/Family members: Relatives of critically ill patients (Lives with the critically ill patient or personal contact to the critically ill patient at least once a month (with regular contacts by phone or other means of communication) and knows the physical and cognitive functioning of the patient) At least one visit to the intensive care unit 18 Years and older (Adult, Older Adult) Possibility of communication in German language (minimum of C1 level of Common European Framework of Reference for Languages) Signed consent form Critically ill patients: Intensive Care Stay = 48 hours Consciousness position: RASS from -3 to +4 Possibility of communication in German language (minimum of C1 level of Common European Framework of Reference for Languages)

Exclusion criteria

Exclusion criteria: Exclusion Criteria for critically ill patients: Prefinal Patients Acute Intoxication

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the Cohen's Kappa coefficient comparing the Family Confusion Assessment Method and the Confusion Assessment Method for Intensive Care Unit.

Secondary

MeasureTime frame
Secondary Outcomes are the Sensitivity and Specificity and the Negative (NPV) and Positive Predictive Value (PPV) of the Family Confusion Assessment Method in critically ill patients to detect Delirium.

Countries

Germany

Contacts

Public ContactNils;Stephanie Happ;Greindl, cand. M.Sc. (Univ.)

Universitätsklinikum Regensburg;Universitätsklinikum Regensburg

nils.happ@ukr.de;stephanie.greindl@ukr.de+49-941-944-7012;+49-941-944-7012

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026