Clinical trial NCT03732443: FAM-CAM Translation and Validation Into German
Official title: Translation and Validation of the Family Confusion Assessment Method (FAM-CAM) Into German for the Detection of Delirium in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Delirium
Critical Illness
Family Members
Keywords: Delirium
Family Members
Critical Illness
ABCDEF
Validation
Translation
FAMCAM
CAM-ICU
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients which are at risk for delirium and where assessing of delirium is not limited by language barriers.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cohen's Kappa Coefficient
timeFrame: During a family visit which is not the first while treated in intensive care (an median of 10 days)
Secondary outcomes:
measure: Specificity of FAM-CAM
timeFrame: During a family visit which is not the first while treated in intensive care (an median of 10 days)
measure: Sensitivity of FAM-CAM
timeFrame: During a family visit which is not the first while treated in intensive care (an median of 10 days)
measure: NPV of FAM-CAM
timeFrame: During a family visit which is not the first while treated in intensive care (an median of 10 days)
measure: PPV of FAM-CAM
timeFrame: During a family visit which is not the first while treated in intensive care (an median of 10 days)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar der TUM
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar der TUM
name: Stefan J Schaller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flanagan NM, Spencer G. Informal caregivers and detection of delirium in postacute care: a correlational study of the confusion assessment method (CAM), confusion assessment method-family assessment method (CAM-FAM) and DSM-IV criteria. Int J Older People Nurs. 2016 Sep;11(3):176-83. doi: 10.1111/opn.12106. Epub 2015 Dec 16.
citation: Aya AGM, Pouchain PH, Thomas H, Ripart J, Cuvillon P. Incidence of postoperative delirium in elderly ambulatory patients: A prospective evaluation using the FAM-CAM instrument. J Clin Anesth. 2019 Mar;53:35-38. doi: 10.1016/j.jclinane.2018.09.034. Epub 2018 Oct 4.
citation: Steis MR, Evans L, Hirschman KB, Hanlon A, Fick DM, Flanagan N, Inouye SK. Screening for delirium using family caregivers: convergent validity of the Family Confusion Assessment Method and interviewer-rated Confusion Assessment Method. J Am Geriatr Soc. 2012 Nov;60(11):2121-6. doi: 10.1111/j.1532-5415.2012.04200.x. Epub 2012 Oct 5.