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FAM-CAM Translation and Validation Into German

Translation and Validation of the Family Confusion Assessment Method (FAM-CAM) Into German for the Detection of Delirium in Critically Ill Patients

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03732443
Acronym
TRAVAGE-FAM
Enrollment
0
Registered
2018-11-06
Start date
2019-01-01
Completion date
2019-03-31
Last updated
2018-12-20

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

Conditions

Critical Illness, Delirium, Family Members

Keywords

Delirium, Family Members, Critical Illness, ABCDEF, Validation, Translation, FAMCAM, CAM-ICU

Brief summary

Validation and Translation of the Family Confusion Assessment Method (FAM-CAM) into German according to Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes of the International Society for Pharmaoeconomics and Outcome Research and comparison to CAM-ICU.

Interventions

DIAGNOSTIC_TESTFAM-CAM

Family Confusion Assessment Method

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Intensive Care Stay ≥ 48 hours * Expected RASS ≥ 3 * Communication possible in German (minimum of C1 level of Common European Framework of Reference for Languages)

Exclusion criteria

* preexisting psychosis, dementia or depression

Design outcomes

Primary

MeasureTime frameDescription
Cohen's Kappa CoefficientDuring a family visit which is not the first while treated in intensive care (an median of 10 days)Cohen's Kappa coefficient comparing the Family Confusion Assessment Method and the Confusion Assessment Method for Intensive Care Unit

Secondary

MeasureTime frameDescription
Specificity of FAM-CAMDuring a family visit which is not the first while treated in intensive care (an median of 10 days)Specificity of the Family Confusion Assessment Method in critically ill patients to detect Delirium
Sensitivity of FAM-CAMDuring a family visit which is not the first while treated in intensive care (an median of 10 days)Sensitivity of the Family Confusion Assessment Method in critically ill patients to detect Delirium
NPV of FAM-CAMDuring a family visit which is not the first while treated in intensive care (an median of 10 days)Negative Predictive Value of the Family Confusion Assessment Method in critically ill patients to detect Delirium
PPV of FAM-CAMDuring a family visit which is not the first while treated in intensive care (an median of 10 days)Positive Predictive Value of the Family Confusion Assessment Method in critically ill patients to detect Delirium

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026