ConfusionNCT01775982
Validation of a French Version of the Confusion Assessment Method (CAM)
An observational study of Confusion and Delirium, run by Centre Hospitalier Universitaire de Nīmes at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- What is being tested?
- Psychiatric evaluation and Geriatric evaluation
- Type of treatment
- Injection or infusion
- How many people
- 102 participants
- Where
- 8 sitesFrance
- Study dates
- Apr 2014to 11 Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CH d'Alès
Alès, 30103
CHU de Rouen - Hôpital de Bois-Guillaume
Bois-Guillaume, 76230
APHP - Hôpital Charles Foix
Ivry-sur-Seine, 94205
APHM - Hôpital Sainte-Marguerite
Marseille, 13274
CHU de Montpellier - Centre Antonin Balmes
Montpellier, 34295
CHU de Nice - Hôpital de Cimiez
Nice, 06003
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
CHU de Reims - Hôpital Maison Blanche
Reims, 51092
About this study
Official title: Validation of a French Version of the Confusion Assessment Method (CAM): a Diagnostic Tool for Acute Confusion Among the Elderly
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:
Read more
- 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 .
- Being tested
- Psychiatric evaluation, Geriatric evaluation
- Keywords
- French language validation, The Confusion Assessment Method (CAM)
- Medical subject headings
- Confusion, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric evaluationOther
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 evaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Psychiatric evaluation; Other: Geriatric evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAM French Version: diagnostic properties
Sensitivity, specificity, positive predictive value, negative predictive value
Measured: Day 0
Secondary outcomes (3)
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
Measured: Day 0
Feasibility of scoring with the French version of the Delirium Index
Measured: day 0
Diagnostic properties of alternative algorithms constructed from items of CAM (French version)
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startApr 2014
- Primary completion11 Feb 2016
- Study completion11 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConfusionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valéry Antoine, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775982
- Sponsor's protocol ID
- PHRC-N/2011/VA-04
- Other IDs
- 2011-A01161-40
- Status last verified
- Jan 2017
- First submitted
- 23 Jan 2013
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Antoine V, Belmin J, Blain H, Bonin-Guillaume S, Goldsmith L, Guerin O, Kergoat MJ, Landais P, Mahmoudi R, Morais JA, Rataboul P, Saber A, Sirvain S, Wolfklein G, de Wazieres B. [The Confusion Assessment Method: Transcultural adaptation of a French version]. Rev Epidemiol Sante Publique. 2018 May;66(3):187-194. doi: 10.1016/j.respe.2018.01.133. Epub 2018 Apr 4. French.
PubMed 29625860
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a French Version of the Confusion Assessment Method (CAM): a Diagnostic Tool for Acute Confusion Among the Elderly
- ClinicalTrials.gov ID
- NCT01775982
- Acronym / sponsor ID
- PHRC-N/2011/VA-04
- Keywords
- French language validation, The Confusion Assessment Method (CAM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 11 Feb 2016 (actual)
- Study completion
- 11 Feb 2016 (actual)
- First posted
- 25 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Other: Psychiatric evaluation, Other: Geriatric evaluationSee 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric evaluationThis 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 | Study population |
| Geriatric evaluationThis 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. | Other | Study population |
Primary outcome
CAM French Version: diagnostic properties
Time frame: Day 0
Sensitivity, specificity, positive predictive value, negative predictive value
3 secondary outcomes
Reliability and quality of the french version of the CAM
Time frame: Day 0
Feasibility of scoring with the French version of the Delirium Index
Time frame: day 0
Diagnostic properties of alternative algorithms constructed from items of CAM (French version)
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 29625860Antoine V, Belmin J, Blain H, Bonin-Guillaume S, Goldsmith L, Guerin O, Kergoat MJ, Landais P, Mahmoudi R, Morais JA, Rataboul P, Saber A, Sirvain S, Wolfklein G, de Wazieres B. [The Confusion Assessment Method: Transcultural adaptation of a French version]. Rev Epidemiol Sante Publique. 2018 May;66(3):187-194. doi: 10.1016/j.respe.2018.01.133. Epub 2018 Apr 4. French.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valéry Antoine, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Confusion and Delirium, run by Centre Hospitalier Universitaire de Nīmes at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAM French Version: diagnostic properties (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01775982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.