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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01775982
First received: January 23, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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​​.


Condition Intervention
Confusion
Delirium
Other: Psychiatric evaluation
Other: Geriatric evaluation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a French Version of the Confusion Assessment Method (CAM): a Diagnostic Tool for Acute Confusion Among the Elderly

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • CAM French Version: diagnostic properties [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Sensitivity, specificity, positive predictive value, negative predictive value


Secondary Outcome Measures:
  • Reliability and quality of the french version of the CAM [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

    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

  • Feasibility of scoring with the French version of the Delirium Index [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • Diagnostic properties of alternative algorithms constructed from items of CAM (French version) [ Time Frame: day 0 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Patient age (years) [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
  • Patient weight (kg) [ Time Frame: Baseline (Day 0) ] [ Designated as safety issue: No ]
  • Height (cm) [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
  • Education level [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
    primary, secondary, or higher

  • Living situation (qualitative) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
    Does the patient live at home? or is the patient institutionalized?

  • Presence/absence of a caregiver [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Hospitalization within the past 3 months? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Has the patient fallen within the past year? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • presence/absence of a visual or hearing impairment [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • patient position during evaluation [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
    qualitative variable: in bed, in a wheelchair, sitting down

  • ADL (Activities of Daily Living) score for the 15 days preceding inclusion [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • IADL (Instrumental Activities of Daily Living) score for the 15 days preceding inclusion [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • ADL (Activities of Daily Living) score at the moment of inclusion [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Clinical and para-clinical examination [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Evaluation of the patient's physiological state [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Diagnosis [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Prescribed drugs [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Comorbidities (Charlson score) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • History of dementia, depression or another psychiatric disorder [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
    Notification in the patient's history of dementia, depression or another psychiatric disorder, assessed by NPI-R and Mini GDS.

  • Severity of clinical condition [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
    Severity of clinical condition: MEWS (Subbe CP et al, 2001) and CGI (Guy W 1976) + Charlson scale

  • Presence or absence of dementia before admission [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
    Presence or absence of dementia before admission (IQCODE French version) (Jorm AF 1994 and Law S, 1995)


Estimated Enrollment: 200
Study Start Date: April 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

Other: 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.


  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients 75 years or older for whom a state of confusion is suspected during hospitalization or during a consultation for a geriatric or memory assessment.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775982

Contacts
Contact: Valéry Antoine, MD +33.(0)4.66.68.31.49 valery.antoine@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CH d'Alès Recruiting
Alès, France, 30103
Sub-Investigator: Serge Sirvain, MD         
CHU de Rouen - Hôpital de Bois-Guillaume Recruiting
Bois Guillaume, France, 76230
Sub-Investigator: Philippe Chassagne, MD, PhD         
APHP - Hôpital Charles Foix Recruiting
Ivry Sur Seine Cedex, France, 94205
Sub-Investigator: Joël Belmin, MD, PhD         
APHM - Hôpital Sainte-Marguerite Recruiting
Marseille, France, 13274
Sub-Investigator: Sylvie Bonin-Guillaume, MD, PhD         
CHU de Montpellier - Centre Antonin Balmes Recruiting
Montpellier cedex 5, France, 34295
Sub-Investigator: Hubert Blain, MD, PhD         
CHU de Nice - Hôpital de Cimiez Recruiting
Nice, France, 06003
Sub-Investigator: Olivier Guerin, MD, PhD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Valéry Antoine, MD         
CHU de Reims - Hôpital Maison Blanche Recruiting
Reims, France, 51092
Sub-Investigator: Jean-Luc Novella, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Valéry Antoine, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01775982     History of Changes
Other Study ID Numbers: PHRC-N/2011/VA-04, 2011-A01161-40
Study First Received: January 23, 2013
Last Updated: April 8, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
French language validation
The Confusion Assessment Method (CAM)

Additional relevant MeSH terms:
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014