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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01775982
Other study ID # PHRC-N/2011/VA-04
Secondary ID 2011-A01161-40
Status Completed
Phase N/A
First received January 23, 2013
Last updated January 31, 2017
Start date April 2014
Est. completion date February 2, 2016

Study information

Verified date January 2017
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date February 2, 2016
Est. primary completion date February 2, 2016
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Psychiatric 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.
Geriatric evaluation
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.

Locations

Country Name City State
France 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

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient age (years) Baseline (day 0)
Other Patient weight (kg) Baseline (Day 0)
Other Height (cm) Baseline (day 0)
Other Education level primary, secondary, or higher baseline (day 0)
Other Living situation (qualitative) Does the patient live at home? or is the patient institutionalized? baseline (day 0)
Other Presence/absence of a caregiver baseline (day 0)
Other Hospitalization within the past 3 months? yes/no baseline (day 0)
Other Has the patient fallen within the past year? yes/no baseline (day 0)
Other presence/absence of a visual or hearing impairment baseline (day 0)
Other patient position during evaluation qualitative variable: in bed, in a wheelchair, sitting down baseline (day 0)
Other ADL (Activities of Daily Living) score for the 15 days preceding inclusion baseline (day 0)
Other IADL (Instrumental Activities of Daily Living) score for the 15 days preceding inclusion baseline (day 0)
Other ADL (Activities of Daily Living) score at the moment of inclusion baseline (day 0)
Other Clinical and para-clinical examination baseline (day 0)
Other Evaluation of the patient's physiological state baseline (day 0)
Other Diagnosis baseline (day 0)
Other Prescribed drugs baseline (day 0)
Other Comorbidities (Charlson score) baseline (day 0)
Other 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. baseline (day 0)
Other Severity of clinical condition Severity of clinical condition: MEWS (Subbe CP et al, 2001) and CGI (Guy W 1976) + Charlson scale baseline (day 0)
Other Presence or absence of dementia before admission Presence or absence of dementia before admission (IQCODE French version) (Jorm AF 1994 and Law S, 1995) baseline (day 0)
Primary CAM French Version: diagnostic properties Sensitivity, specificity, positive predictive value, negative predictive value Day 0
Secondary 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
Day 0
Secondary Feasibility of scoring with the French version of the Delirium Index day 0
Secondary Diagnostic properties of alternative algorithms constructed from items of CAM (French version) day 0
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