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

NCT ID: NCT01775982

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-02-11

Brief Summary

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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 Description

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Conditions

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Confusion Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study population

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Intervention: Psychiatric evaluation Intervention: Geriatric evaluation

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.

Psychiatric evaluation

Intervention Type OTHER

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.

Geriatric evaluation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A family member of the patient, or his/her "trusted person" must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Hospitalization in geriatric short stay OR patient consulting at a geriatric assessment center / memory clinic OR geriatric day hospitalization
* Patients for whom a state of confusion is suspected during the pre-inclusion visit run-in based on the following criteria:
* Presence of a cognitive function disorder as defined by a score greater than or equal to 3 on the Short Portable Mental Status Questionnaire (SPMSQ) (Pfeiffer E, 1975) AND / OR
* Presence of a mood disorder and / or behavior disorder (regardless of duration) according to the patient's family or caregivers
* Presence of a caregiver who can answer questionnaires concerning activities of everyday life

Exclusion Criteria

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient's family or "trusted-person" refuses to sign the consent
* The patient does not understand french
* Severe aphasia
* Stay is \< = 3 days
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valéry Antoine, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CH d'Alès

Alès, , France

Site Status

CHU de Rouen - Hôpital de Bois-Guillaume

Bois-Guillaume, , France

Site Status

APHP - Hôpital Charles Foix

Ivry-sur-Seine, , France

Site Status

APHM - Hôpital Sainte-Marguerite

Marseille, , France

Site Status

CHU de Montpellier - Centre Antonin Balmes

Montpellier, , France

Site Status

CHU de Nice - Hôpital de Cimiez

Nice, , France

Site Status

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

CHU de Reims - Hôpital Maison Blanche

Reims, , France

Site Status

Countries

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France

References

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Antoine V, Belmin J, Blain H, Bonin-Guillaume S, Goldsmith L, Guerin O, Kergoat MJ, Landais P, Mahmoudi R, Morais JA, Rataboul P, Saber A, Sirvain S, Wolfklein G, de Wazieres B. [The Confusion Assessment Method: Transcultural adaptation of a French version]. Rev Epidemiol Sante Publique. 2018 May;66(3):187-194. doi: 10.1016/j.respe.2018.01.133. Epub 2018 Apr 4. French.

Reference Type RESULT
PMID: 29625860 (View on PubMed)

Other Identifiers

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2011-A01161-40

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-N/2011/VA-04

Identifier Type: -

Identifier Source: org_study_id

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