Validation of a French Version of the Confusion Assessment Method (CAM)

Delirium Clinical Trial

Official title:

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

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
• 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

Related Conditions & MeSH terms

• Confusion
• Consciousness Disorders
• Delirium

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