FAM-CAM Translation and Validation Into German

Critical Illness Clinical Trial

— TRAVAGE-FAM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03732443
• Other study ID #: TRAVAGE-FAM
• Status: Withdrawn
• Start date: January 1, 2019
• Est. completion date: March 31, 2019

Study information

• Verified date: December 2018
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Delirium
• Family Members

Intervention

Diagnostic Test:
• FAM-CAM
Family Confusion Assessment Method

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar der TUM	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. 2018 Oct 3;53:35-38. doi: 10.1016/j.jclinane.2018.09.034. [Epub ahead of print] — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)