Validation of the 3D-CAM and the UB-CAM in French (French-UB-CAM)

April 3, 2024 updated by: Hospices Civils de Lyon

Validation of the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM) and the Ultra-Brief CAM (UB-CAM) in French.

Delirium is very common in hospitalized older patients and associated with serious clinical bad outcomes (e.g. increased risk of functional decline and death). Despite its high prevalence in the hospital setting, delirium remains underdiagnosed. A better identification would allow an early management and a reduction of its complications.

The validation of easy-to-use and quick and formalized tools for the identification of delirium and their implementation in the clinical practice are necessary.

Recently, the 3D-CAM (3-minutes Diagnostic interview for Confusion Assessment Method -defined delirium) and the UB-CAM (Ultra-Brief CAM) showed very high sensitivity and specificity (> 90%), compared to the reference standard (Diagnostic and Statistical Manual of Mental Disorders (DSM criteria)) for the diagnosis of delirium.

The investigators aimed to evaluate the sensitivity and specificity of the French versions of the 3D-CAM and the UB-CAM used in delirium screening in older adults hospitalized in geriatric units, compared to reference standard.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

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

  • France
    • Lyon
      • Villeurbanne, Lyon, France, 69100
        • Hôpital des Charpennes, Institut du Vieillissement, Hospices Civils de Lyon

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

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Older adults hospitalized in acute geriatric units

Description

Inclusion Criteria:

  • Adults hospitalized in acute geriatric units
  • Aged 65 or older
  • Patient (or relative) not objecting to participating in the study

Exclusion Criteria:

- Legal protection regimes (guardianship, curatorship)

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: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Older adults hospitalized in acute geriatric units
Response to a questionnaire
Diagnostic test: Delirium screening using 3D-CAM and UB-CAM
Patients will be evaluated with 3D-CAM and UB-CAM by a trained examiner (geriatrician, resident or neuropsychologist). On the same day, they will be given a reference diagnosis of delirium based on DSM-V criteria by another trained examiner, blind to the results of the UB-CAM and 3D-CAM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the performance of a rapid diagnostic tool (UB-CAM) for acute confusional state, translated into French
Time Frame: At inclusion
Presence or absence of a confusional state (with UB-CAM and the gold standard: DSM-V criteria)
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the time taken to use this tool
Time Frame: At inclusion
Completion time (minutes, seconds)
At inclusion
Evaluation of the diagnostic performance of another diagnostic tool (3D-CAM), already translated into French
Time Frame: At inclusion
Presence or absence of a confusional state (with 3D-CAM and the gold standard: DSM-V criteria)
At inclusion

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Antoine GARNIER-CRUSSARD, MD, MSc, Hospices Civils de Lyon

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 (Actual)

March 31, 2022

Primary Completion (Actual)

March 27, 2024

Study Completion (Actual)

March 27, 2024

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_0903
  • 2021-A02130-41 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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