Validation of a French Version of the Confusion Assessment Method (CAM)
- Conditions
- ConfusionDelirium
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- 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
- 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
- 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 patientsFeasibility of scoring with the French version of the Delirium Index day 0
Trial Locations
- Locations (8)
CH d'Alès
🇫🇷Alès, France
CHU de Rouen - Hôpital de Bois-Guillaume
🇫🇷Bois Guillaume, France
APHP - Hôpital Charles Foix
🇫🇷Ivry Sur Seine Cedex, France
APHM - Hôpital Sainte-Marguerite
🇫🇷Marseille, France
CHU de Montpellier - Centre Antonin Balmes
🇫🇷Montpellier cedex 5, France
CHU de Nice - Hôpital de Cimiez
🇫🇷Nice, France
CHU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France
CHU de Reims - Hôpital Maison Blanche
🇫🇷Reims, France
CH d'Alès🇫🇷Alès, France