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
Verified date | January 2017 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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:
- 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 .
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
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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