An observational study in Confusion and Delirium, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 8 sites in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational
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:
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 .
83 studies on the registry are indexed under Confusion; 20 are open to participants now.
This study's enrollment of 102 is below the median of 120 across 28 observational studies indexed under Confusion.
Browse Confusion studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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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.
Exclusion Criteria:
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
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.
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.
CAM French Version: diagnostic properties
Sensitivity, specificity, positive predictive value, negative predictive value
Time frame: Day 0
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
Time frame: Day 0
Feasibility of scoring with the French version of the Delirium Index
Time frame: day 0
Diagnostic properties of alternative algorithms constructed from items of CAM (French version)
Time frame: day 0
Patient age (years)
Time frame: Baseline (day 0)
Patient weight (kg)
Time frame: Baseline (Day 0)
Height (cm)
Time frame: Baseline (day 0)
Education level
primary, secondary, or higher
Time frame: baseline (day 0)
Living situation (qualitative)
Does the patient live at home? or is the patient institutionalized?
Time frame: baseline (day 0)
Presence/absence of a caregiver
Time frame: baseline (day 0)
Hospitalization within the past 3 months? yes/no
Time frame: baseline (day 0)
Has the patient fallen within the past year? yes/no
Time frame: baseline (day 0)
presence/absence of a visual or hearing impairment
Time frame: baseline (day 0)
patient position during evaluation
qualitative variable: in bed, in a wheelchair, sitting down
Time frame: baseline (day 0)
ADL (Activities of Daily Living) score for the 15 days preceding inclusion
Time frame: baseline (day 0)
IADL (Instrumental Activities of Daily Living) score for the 15 days preceding inclusion
Time frame: baseline (day 0)
ADL (Activities of Daily Living) score at the moment of inclusion
Time frame: baseline (day 0)
Clinical and para-clinical examination
Time frame: baseline (day 0)
Evaluation of the patient's physiological state
Time frame: baseline (day 0)
Diagnosis
Time frame: baseline (day 0)
Prescribed drugs
Time frame: baseline (day 0)
Comorbidities (Charlson score)
Time frame: 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.
Time frame: baseline (day 0)
Severity of clinical condition
Severity of clinical condition: MEWS (Subbe CP et al, 2001) and CGI (Guy W 1976) + Charlson scale
Time frame: 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)
Time frame: baseline (day 0)
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes