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

• Conditions: F05; Delirium, not induced by alcohol and other psychoactive substances

• Registration Number: DRKS00016930
• Lead Sponsor: niversitätsklinikum Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-15
• Study Completion: 2020-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

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 for critically ill patients:
Prefinal Patients
Acute Intoxication

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.