Skip to main content
OpenTrials
Completed

NCT Number: NCT01775982

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

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 .

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH d'Alès, Alès, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychiatric evaluation

Other

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

Other

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.

Primary outcomes

  1. CAM French Version: diagnostic properties

    Time frame: Day 0

    Sensitivity, specificity, positive predictive value, negative predictive value

Secondary outcomes

  1. Reliability and quality of the french version of the CAM

    Time frame: Day 0

    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

  2. Feasibility of scoring with the French version of the Delirium Index

    Time frame: day 0

  3. Diagnostic properties of alternative algorithms constructed from items of CAM (French version)

    Time frame: day 0

Other outcomes

  1. Patient age (years)

    Time frame: Baseline (day 0)

  2. Patient weight (kg)

    Time frame: Baseline (Day 0)

  3. Height (cm)

    Time frame: Baseline (day 0)

  4. Education level

    Time frame: baseline (day 0)

    primary, secondary, or higher

  5. Living situation (qualitative)

    Time frame: baseline (day 0)

    Does the patient live at home? or is the patient institutionalized?

  6. Presence/absence of a caregiver

    Time frame: baseline (day 0)

  7. Hospitalization within the past 3 months? yes/no

    Time frame: baseline (day 0)

  8. Has the patient fallen within the past year? yes/no

    Time frame: baseline (day 0)

  9. presence/absence of a visual or hearing impairment

    Time frame: baseline (day 0)

  10. patient position during evaluation

    Time frame: baseline (day 0)

    qualitative variable: in bed, in a wheelchair, sitting down

  11. ADL (Activities of Daily Living) score for the 15 days preceding inclusion

    Time frame: baseline (day 0)

  12. IADL (Instrumental Activities of Daily Living) score for the 15 days preceding inclusion

    Time frame: baseline (day 0)

  13. ADL (Activities of Daily Living) score at the moment of inclusion

    Time frame: baseline (day 0)

  14. Clinical and para-clinical examination

    Time frame: baseline (day 0)

  15. Evaluation of the patient's physiological state

    Time frame: baseline (day 0)

  16. Diagnosis

    Time frame: baseline (day 0)

  17. Prescribed drugs

    Time frame: baseline (day 0)

  18. Comorbidities (Charlson score)

    Time frame: baseline (day 0)

  19. History of dementia, depression or another psychiatric disorder

    Time frame: baseline (day 0)

    Notification in the patient's history of dementia, depression or another psychiatric disorder, assessed by NPI-R and Mini GDS.

  20. Severity of clinical condition

    Time frame: baseline (day 0)

    Severity of clinical condition: MEWS (Subbe CP et al, 2001) and CGI (Guy W 1976) + Charlson scale

  21. Presence or absence of dementia before admission

    Time frame: baseline (day 0)

    Presence or absence of dementia before admission (IQCODE French version) (Jorm AF 1994 and Law S, 1995)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2013
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.