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

NCT01775982 | Completed

• 2 other identifiers: PHRC-N/2011/VA-042011-A01161-40
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 8

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 .

Conditions

Confusion; Delirium

Keywords

French language validation; The Confusion Assessment Method (CAM)

Outcome Measures

Primary Outcomes (1)

• CAM French Version: diagnostic properties

  Sensitivity, specificity, positive predictive value, negative predictive value

  Day 0

Secondary Outcomes (3)

• Reliability and quality of the french version of the CAM

  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 Outcomes (21)

• Patient age (years)

  Baseline (day 0)

• Patient weight (kg)

  Baseline (Day 0)

• Height (cm)

  Baseline (day 0)

Study Arms (1)

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; Other: Geriatric evaluation

Interventions

Psychiatric evaluation 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.

Study population

Geriatric evaluation 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.

Study population

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (8)

CH d'Alès

Alès, 30103, France

Location

CHU de Rouen - Hôpital de Bois-Guillaume

Bois-Guillaume, 76230, France

Location

APHP - Hôpital Charles Foix

Ivry-sur-Seine, 94205, France

Location

APHM - Hôpital Sainte-Marguerite

Marseille, 13274, France

Location

CHU de Montpellier - Centre Antonin Balmes

Montpellier, 34295, France

Location

CHU de Nice - Hôpital de Cimiez

Nice, 06003, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHU de Reims - Hôpital Maison Blanche

Reims, 51092, France

Location

Related Publications (1)

• 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.

  PMID: 29625860 RESULT

MeSH Terms

Conditions

Confusion; Delirium

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Valéry Antoine, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 25, 2013
• Study Start: April 1, 2014
• Primary Completion: February 11, 2016
• Study Completion: February 11, 2016
• Last Updated: November 19, 2025

Record last verified: 2017-01

Locations

FR (8)