NCT03732443

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

October 29, 2018

Last Update Submit

December 18, 2018

Conditions

DeliriumCritical IllnessFamily Members

Keywords

DeliriumFamily MembersCritical IllnessABCDEFValidationTranslationFAMCAMCAM-ICU

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Specificity of FAM-CAM

    During a family visit which is not the first while treated in intensive care (an median of 10 days)

  • Sensitivity of FAM-CAM

    During a family visit which is not the first while treated in intensive care (an median of 10 days)

  • NPV of FAM-CAM

    During a family visit which is not the first while treated in intensive care (an median of 10 days)

  • PPV of FAM-CAM

    During a family visit which is not the first while treated in intensive care (an median of 10 days)

Study Arms (1)

Critical Ill Patients

Critically ill patients with a RASS ≥ 3. FAM-CAM and CAM-ICU will be administered.

Diagnostic Test: FAM-CAM

Interventions

FAM-CAMDIAGNOSTIC_TEST

Family Confusion Assessment Method

Critical Ill Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients which are at risk for delirium and where assessing of delirium is not limited by language barriers.

You may qualify if:

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

You may not qualify if:

  • preexisting psychosis, dementia or depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar der TUM

Munich, Bavaria, 81675, Germany

Location

Related Publications (3)

  • 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.

    PMID: 26669904BACKGROUND

  • 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.

    PMID: 30292069BACKGROUND

  • 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.

    PMID: 23039310BACKGROUND

MeSH Terms

Conditions

DeliriumCritical Illness

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersDisease AttributesPathologic Processes

Study Officials

  • Stefan J Schaller, MD

    Klinikum rechts der Isar der TUM

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2018

First Posted

November 6, 2018

Study Start

January 1, 2019

Primary Completion

February 28, 2019

Study Completion

March 31, 2019

Last Updated

December 20, 2018

Record last verified: 2018-12

Locations

DE(1)