Clinical Trial: Validation of a French Version of the Confusion Assessment Method (CAM)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Validation of a French Version of the Confusion Assessment Method (CAM): a Diagnostic Tool for Acute Confusion Among the Elderly

Brief Summary:

To validate the French version of the CAM, a multicenter diagnostic study will be conducted. The principle of this study is identical to the study of Inouye which initially validated the CAM in 1990. This is to verify the diagnostic properties of the CAM (French version) compared to the gold standard represented by the confused state of psychiatric diagnosis using the DSM.

A representative sample of geriatric patients for whom a delirium is suspected, will be recruited in the various participating centers, patients will undergo two consecutive visits:

  • A visit by a geriatrician, during which the confused state of the patient will be evaluated using the French version of the CAM.
  • A visit by a psychiatrist during which the diagnosis of confusional state will be evaluated using the gold standard criteria of the DSM IV.

These two evaluations will be conducted on the same day and blinded from each other.

The order of these two procedures will be balanced within each center. This process will allow the calculation of diagnostic parameters of the CAM French version (validation competitive): sensitivity, specificity, positive and negative predictive values .


Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome: CAM French Version: diagnostic properties [ Time Frame: Day 0 ]

Sensitivity, specificity, positive predictive value, negative predictive value


Original Primary Outcome:

  • CAM French Version [ Time Frame: Day 2 ]
    A visit by a geriatrician, during which the confused state of the patient will be evaluated using the French version of the CAM.
  • DSM-IV assessment [ Time Frame: Day 2 ]
    A visit by a psychiatrist during which the diagnosis of confusional state will be evaluated using the gold standard criteria of the DSM IV.


Current Secondary Outcome:

  • Reliability and quality of the french version of the CAM [ Time Frame: Day 0 ]

    Parameters of reliability and quality of the tool:

    • Inter-rater Agreement (measured by a coefficient of correlation) between two evaluators: geriatrician and a nurse or psychologist
    • Internal consistency of the questionnaire assessed by calculating Cronbach's alpha
    • Time required for assessment
    • Acceptability by clinicians
    • Tolerance of patients
  • Feasibility of scoring with the French version of the Delirium Index [ Time Frame: day 0 ]
  • Diagnostic properties of alternative algorithms constructed from items of CAM (French version) [ Time Frame: day 0 ]


Original Secondary Outcome:

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: January 23, 2013
Date Started: April 2014
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017