FAM-CAM Translation and Validation Into German (TRAVAGE-FAM)

December 18, 2018 updated by: Technical University of Munich

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Klinikum rechts der Isar der TUM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Critical Ill Patients
Critically ill patients with a RASS ≥ 3. FAM-CAM and CAM-ICU will be administered.
Diagnostic test: FAM-CAM
Family Confusion Assessment Method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen's Kappa Coefficient
Time Frame: During 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
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
Time Frame: During 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
During a family visit which is not the first while treated in intensive care (an median of 10 days)
Sensitivity of FAM-CAM
Time Frame: During 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
During a family visit which is not the first while treated in intensive care (an median of 10 days)
NPV of FAM-CAM
Time Frame: During 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
During a family visit which is not the first while treated in intensive care (an median of 10 days)
PPV of FAM-CAM
Time Frame: During 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
During a family visit which is not the first while treated in intensive care (an median of 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Stefan J Schaller, MD, Klinikum rechts der Isar der TUM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

February 28, 2019

Study Completion (Anticipated)

March 31, 2019

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAVAGE-FAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data sharing can be requested for research collaboration purpose or meta-analysis. A data share agreement will have to be signed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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