- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01775982
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
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 .
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Alès, France, 30103
- CH d'Alès
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Bois Guillaume, France, 76230
- CHU de Rouen - Hôpital de Bois-Guillaume
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Ivry Sur Seine Cedex, France, 94205
- APHP - Hôpital Charles Foix
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Marseille, France, 13274
- APHM - Hôpital Sainte-Marguerite
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Montpellier cedex 5, France, 34295
- CHU de Montpellier - Centre Antonin Balmes
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Nice, France, 06003
- CHU de Nice - Hôpital de Cimiez
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Nîmes Cedex 09, France, 30029
- CHU de Nimes - Hopital Universitaire Caremeau
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Reims, France, 51092
- CHU de Reims - Hôpital Maison Blanche
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
This evaluation is carried out in several stages:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAM French Version: diagnostic properties
Time Frame: Day 0
|
Sensitivity, specificity, positive predictive value, negative predictive value
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reliability and quality of the french version of the CAM
Time Frame: Day 0
|
Parameters of reliability and quality of the tool:
|
Day 0
|
Feasibility of scoring with the French version of the Delirium Index
Time Frame: day 0
|
day 0
|
|
Diagnostic properties of alternative algorithms constructed from items of CAM (French version)
Time Frame: day 0
|
day 0
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient age (years)
Time Frame: Baseline (day 0)
|
Baseline (day 0)
|
|
Patient weight (kg)
Time Frame: Baseline (Day 0)
|
Baseline (Day 0)
|
|
Height (cm)
Time Frame: Baseline (day 0)
|
Baseline (day 0)
|
|
Education level
Time Frame: baseline (day 0)
|
primary, secondary, or higher
|
baseline (day 0)
|
Living situation (qualitative)
Time Frame: baseline (day 0)
|
Does the patient live at home? or is the patient institutionalized?
|
baseline (day 0)
|
Presence/absence of a caregiver
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
Hospitalization within the past 3 months? yes/no
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
Has the patient fallen within the past year? yes/no
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
presence/absence of a visual or hearing impairment
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
patient position during evaluation
Time Frame: baseline (day 0)
|
qualitative variable: in bed, in a wheelchair, sitting down
|
baseline (day 0)
|
ADL (Activities of Daily Living) score for the 15 days preceding inclusion
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
IADL (Instrumental Activities of Daily Living) score for the 15 days preceding inclusion
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
ADL (Activities of Daily Living) score at the moment of inclusion
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
Clinical and para-clinical examination
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
Evaluation of the patient's physiological state
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
Diagnosis
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
Prescribed drugs
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
Comorbidities (Charlson score)
Time Frame: baseline (day 0)
|
baseline (day 0)
|
|
History of dementia, depression or another psychiatric disorder
Time Frame: baseline (day 0)
|
Notification in the patient's history of dementia, depression or another psychiatric disorder, assessed by NPI-R and Mini GDS.
|
baseline (day 0)
|
Severity of clinical condition
Time Frame: baseline (day 0)
|
Severity of clinical condition: MEWS (Subbe CP et al, 2001) and CGI (Guy W 1976) + Charlson scale
|
baseline (day 0)
|
Presence or absence of dementia before admission
Time Frame: baseline (day 0)
|
Presence or absence of dementia before admission (IQCODE French version) (Jorm AF 1994 and Law S, 1995)
|
baseline (day 0)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Valéry Antoine, MD, Centre Hospitalier Universitaire de Nîmes
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRC-N/2011/VA-04
- 2011-A01161-40 (Other Identifier: RCB number)
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