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

NCT01775982 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2025-11-19

No results posted yet for this study

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 .

Conditions

Interventions

OTHER

Psychiatric evaluation

This evaluation is carried out in several stages: * Assessment of cognitive functioning; * Interview with a relative; * Interview with caregivers; * Evaluation of the presence of delirium according to DSM-IV criteria; * Evaluation of the presence of anxiety, depressive syndrome, dementia or other DSM IV; * Reports of adverse events. A potential intervention order effect will be taken into account by balancing in each center the number of evaluations beginning with the geriatric assessment and those starting with the psychiatric assessment.

OTHER

Geriatric evaluation

This evaluation includes a brief interview with a caregiver, diverse scorings (CAM, Delirium Index, Mini Geriatric Depression Scale, Modified Early Warning Score, Clinical Global Impression sclae, Algo Plus), and adverse event reporting. CAM scoring is carried out by a trained geriatrician and a trained nurse and/or a psychologist. A potential intervention order effect will be taken into account by balancing in each center the number of evaluations beginning with the geriatric assessment and those starting with the psychiatric assessment.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Valéry Antoine, MD · Centre Hospitalier Universitaire de Nîmes

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-02-11
Completion
2016-02-11

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01775982 on ClinicalTrials.gov