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

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

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 .

Study Overview

• Status: Completed
• Conditions: Delirium; Confusion
• Intervention / Treatment: Other: Psychiatric evaluation; Other: Geriatric evaluation

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• France
  • Alès, France, 30103
    • CH d'Alès
  • Bois-Guillaume, France, 76230
    • CHU de Rouen - Hôpital de Bois-Guillaume
  • Ivry-sur-Seine, France, 94205
    • APHP - Hôpital Charles Foix
  • Marseille, France, 13274
    • APHM - Hôpital Sainte-Marguerite
  • Montpellier, France, 34295
    • CHU de Montpellier - Centre Antonin Balmes
  • Nice, France, 06003
    • CHU de Nice - Hôpital de Cimiez
  • Nîmes, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau
  • Reims, France, 51092
    • CHU de Reims - Hôpital Maison Blanche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients 75 years or older for whom a state of confusion is suspected during hospitalization or during a consultation for a geriatric or memory assessment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study population; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAM French Version: diagnostic properties	Sensitivity, specificity, positive predictive value, negative predictive value	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability and quality of the french version of the CAM	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	Day 0
Feasibility of scoring with the French version of the Delirium Index		day 0
Diagnostic properties of alternative algorithms constructed from items of CAM (French version)		day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient age (years)		Baseline (day 0)
Patient weight (kg)		Baseline (Day 0)
Height (cm)		Baseline (day 0)
Education level	primary, secondary, or higher	baseline (day 0)
Living situation (qualitative)	Does the patient live at home? or is the patient institutionalized?	baseline (day 0)
Presence/absence of a caregiver		baseline (day 0)
Hospitalization within the past 3 months? yes/no		baseline (day 0)
Has the patient fallen within the past year? yes/no		baseline (day 0)
presence/absence of a visual or hearing impairment		baseline (day 0)
patient position during evaluation	qualitative variable: in bed, in a wheelchair, sitting down	baseline (day 0)
ADL (Activities of Daily Living) score for the 15 days preceding inclusion		baseline (day 0)
IADL (Instrumental Activities of Daily Living) score for the 15 days preceding inclusion		baseline (day 0)
ADL (Activities of Daily Living) score at the moment of inclusion		baseline (day 0)
Clinical and para-clinical examination		baseline (day 0)
Evaluation of the patient's physiological state		baseline (day 0)
Diagnosis		baseline (day 0)
Prescribed drugs		baseline (day 0)
Comorbidities (Charlson score)		baseline (day 0)
History of dementia, depression or another psychiatric disorder	Notification in the patient's history of dementia, depression or another psychiatric disorder, assessed by NPI-R and Mini GDS.	baseline (day 0)
Severity of clinical condition	Severity of clinical condition: MEWS (Subbe CP et al, 2001) and CGI (Guy W 1976) + Charlson scale	baseline (day 0)
Presence or absence of dementia before admission	Presence or absence of dementia before admission (IQCODE French version) (Jorm AF 1994 and Law S, 1995)	baseline (day 0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Valéry Antoine, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): February 11, 2016
• Study Completion (Actual): February 11, 2016

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimated): January 25, 2013

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: French language validation; The Confusion Assessment Method (CAM)
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium; Confusion
• Other Study ID Numbers: PHRC-N/2011/VA-04; 2011-A01161-40 (Other Identifier: ANSM)