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

Completed

• Conditions: Confusion; Delirium
• Interventions: Other: Psychiatric evaluation; Other: Geriatric evaluation

• Registration Number: NCT01775982
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-25
• Study Start: 2014-04
• Primary Completion: 2016-02-02
• Study Completion: 2016-02-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Psychiatric evaluation	See inclusion and exclusion criteria. 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.
Study population	Geriatric evaluation	See inclusion and exclusion criteria. 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.

Primary Outcome Measures

Name	Time	Method
CAM French Version: diagnostic properties	Day 0	Sensitivity, specificity, positive predictive value, negative predictive value

Secondary Outcome Measures

Name	Time	Method
Diagnostic properties of alternative algorithms constructed from items of CAM (French version)	day 0
Reliability and quality of the french version of the CAM	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	day 0

Trial Locations

Locations (8)

CHU de Montpellier - Centre Antonin Balmes; 🇫🇷 Montpellier cedex 5, France

APHM - Hôpital Sainte-Marguerite; 🇫🇷 Marseille, France

CHU de Rouen - Hôpital de Bois-Guillaume; 🇫🇷 Bois Guillaume, France

CHU de Reims - Hôpital Maison Blanche; 🇫🇷 Reims, France

CH d'Alès; 🇫🇷 Alès, France

APHP - Hôpital Charles Foix; 🇫🇷 Ivry Sur Seine Cedex, France

CHU de Nice - Hôpital de Cimiez; 🇫🇷 Nice, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France