Clinical trial NCT01775982: Validation of a French Version of the Confusion Assessment Method (CAM)
Official title: Validation of a French Version of the Confusion Assessment Method (CAM): a Diagnostic Tool for Acute Confusion Among the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Confusion
Delirium
Keywords: French language validation
The Confusion Assessment Method (CAM)
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 102
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 .


Eligibility criteria: 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

Primary outcomes:
measure: CAM French Version: diagnostic properties
timeFrame: Day 0
Secondary outcomes:
measure: Reliability and quality of the french version of the CAM
timeFrame: Day 0
measure: Feasibility of scoring with the French version of the Delirium Index
timeFrame: day 0
measure: Diagnostic properties of alternative algorithms constructed from items of CAM (French version)
timeFrame: day 0
Other outcomes:
measure: Patient age (years)
timeFrame: Baseline (day 0)
measure: Patient weight (kg)
timeFrame: Baseline (Day 0)
measure: Height (cm)
timeFrame: Baseline (day 0)
measure: Education level
timeFrame: baseline (day 0)
measure: Living situation (qualitative)
timeFrame: baseline (day 0)
measure: Presence/absence of a caregiver
timeFrame: baseline (day 0)
measure: Hospitalization within the past 3 months? yes/no
timeFrame: baseline (day 0)
measure: Has the patient fallen within the past year? yes/no
timeFrame: baseline (day 0)
measure: presence/absence of a visual or hearing impairment
timeFrame: baseline (day 0)
measure: patient position during evaluation
timeFrame: baseline (day 0)
measure: ADL (Activities of Daily Living) score for the 15 days preceding inclusion
timeFrame: baseline (day 0)
measure: IADL (Instrumental Activities of Daily Living) score for the 15 days preceding inclusion
timeFrame: baseline (day 0)
measure: ADL (Activities of Daily Living) score at the moment of inclusion
timeFrame: baseline (day 0)
measure: Clinical and para-clinical examination
timeFrame: baseline (day 0)
measure: Evaluation of the patient's physiological state
timeFrame: baseline (day 0)
measure: Diagnosis
timeFrame: baseline (day 0)
measure: Prescribed drugs
timeFrame: baseline (day 0)
measure: Comorbidities (Charlson score)
timeFrame: baseline (day 0)
measure: History of dementia, depression or another psychiatric disorder
timeFrame: baseline (day 0)
measure: Severity of clinical condition
timeFrame: baseline (day 0)
measure: Presence or absence of dementia before admission
timeFrame: baseline (day 0)
Locations:
city: Alès
country: France
facility: CH d'Alès
city: Bois Guillaume
country: France
facility: CHU de Rouen - Hôpital de Bois-Guillaume
city: Ivry Sur Seine Cedex
country: France
facility: APHP - Hôpital Charles Foix
city: Marseille
country: France
facility: APHM - Hôpital Sainte-Marguerite
city: Montpellier cedex 5
country: France
facility: CHU de Montpellier - Centre Antonin Balmes
city: Nice
country: France
facility: CHU de Nice - Hôpital de Cimiez
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Reims
country: France
facility: CHU de Reims - Hôpital Maison Blanche
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Valéry Antoine, MD
role: PRINCIPAL_INVESTIGATOR
References: