FAM-CAM Translation and Validation Into German

Study Overview
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Brief Summary
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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.

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

Conditions
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Delirium, Critical Illness, Family Members

Intervention / Treatment
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* Diagnostic Test: FAM-CAM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critical Ill Patients<br>Critically ill patients with a RASS ≥ 3. FAM-CAM and CAM-ICU will be administered. | Diagnostic Test: FAM-CAM<br>* Family Confusion Assessment Method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen's Kappa Coefficient | Cohen's Kappa coefficient comparing the Family Confusion Assessment Method and the Confusion Assessment Method for Intensive Care Unit | During a family visit which is not the first while treated in intensive care (an median of 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of FAM-CAM | Specificity of the Family Confusion Assessment Method in critically ill patients to detect Delirium | During a family visit which is not the first while treated in intensive care (an median of 10 days) | 
| Sensitivity of FAM-CAM | Sensitivity of the Family Confusion Assessment Method in critically ill patients to detect Delirium | During a family visit which is not the first while treated in intensive care (an median of 10 days) | 
| NPV of FAM-CAM | Negative Predictive Value of the Family Confusion Assessment Method in critically ill patients to detect Delirium | During a family visit which is not the first while treated in intensive care (an median of 10 days) | 
| PPV of FAM-CAM | Positive Predictive Value of the Family Confusion Assessment Method in critically ill patients to detect Delirium | During a family visit which is not the first while treated in intensive care (an median of 10 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAM-ICU, Delirium, Family Members, Critical Illness, ABCDEF, Validation, Translation, FAMCAM