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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01775982
Enrollment
102
Registered
2013-01-25
Start date
2014-04-30
Completion date
2016-02-11
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Confusion, Delirium

Keywords

French language validation, The Confusion Assessment Method (CAM)

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 .

Interventions

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.

OTHERGeriatric 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

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CAM French Version: diagnostic propertiesDay 0Sensitivity, specificity, positive predictive value, negative predictive value

Secondary

MeasureTime frameDescription
Reliability and quality of the french version of the CAMDay 0Parameters 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 Indexday 0
Diagnostic properties of alternative algorithms constructed from items of CAM (French version)day 0

Other

MeasureTime frameDescription
Living situation (qualitative)baseline (day 0)Does the patient live at home? or is the patient institutionalized?
Presence/absence of a caregiverbaseline (day 0)
Hospitalization within the past 3 months? yes/nobaseline (day 0)
Has the patient fallen within the past year? yes/nobaseline (day 0)
presence/absence of a visual or hearing impairmentbaseline (day 0)
patient position during evaluationbaseline (day 0)qualitative variable: in bed, in a wheelchair, sitting down
ADL (Activities of Daily Living) score for the 15 days preceding inclusionbaseline (day 0)
IADL (Instrumental Activities of Daily Living) score for the 15 days preceding inclusionbaseline (day 0)
Patient age (years)Baseline (day 0)
Clinical and para-clinical examinationbaseline (day 0)
Evaluation of the patient's physiological statebaseline (day 0)
Diagnosisbaseline (day 0)
Prescribed drugsbaseline (day 0)
Comorbidities (Charlson score)baseline (day 0)
History of dementia, depression or another psychiatric disorderbaseline (day 0)Notification in the patient's history of dementia, depression or another psychiatric disorder, assessed by NPI-R and Mini GDS.
Severity of clinical conditionbaseline (day 0)Severity of clinical condition: MEWS (Subbe CP et al, 2001) and CGI (Guy W 1976) + Charlson scale
Presence or absence of dementia before admissionbaseline (day 0)Presence or absence of dementia before admission (IQCODE French version) (Jorm AF 1994 and Law S, 1995)
ADL (Activities of Daily Living) score at the moment of inclusionbaseline (day 0)
Patient weight (kg)Baseline (Day 0)
Height (cm)Baseline (day 0)
Education levelbaseline (day 0)primary, secondary, or higher

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026