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Clinical Trials/NCT01775982
NCT01775982
Completed
N/A

Validation of a French Version of the Confusion Assessment Method (CAM): a Diagnostic Tool for Acute Confusion Among the Elderly

Centre Hospitalier Universitaire de Nīmes8 sites in 1 country102 target enrollmentApril 1, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Confusion
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
102
Locations
8
Primary Endpoint
CAM French Version: diagnostic properties
Status
Completed
Last Updated
5 months ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
April 1, 2014
End Date
February 11, 2016
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

CAM French Version: diagnostic properties

Time Frame: Day 0

Sensitivity, specificity, positive predictive value, negative predictive value

Secondary Outcomes

  • 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)
  • Feasibility of scoring with the French version of the Delirium Index(day 0)

Study Sites (8)

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