DeliriumFrench-UB-CAMNCT05242887
Validation of the 3D-CAM and the UB-CAM in French
An observational study of Delirium, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Delirium is very common in hospitalized older patients and associated with serious clinical bad outcomes (e.g. increased risk of functional decline and death). Despite its high prevalence in the hospital setting, delirium remains underdiagnosed. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Delirium screening using 3D-CAM and UB-CAM
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2022to 27 Mar 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older adults hospitalized in acute geriatric units
Who may be able to join
- Adults hospitalized in acute geriatric units
- Aged 65 or older
- Patient (or relative) not objecting to participating in the study
Who cannot join
- Legal protection regimes (guardianship, curatorship)
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital des Charpennes, Institut du Vieillissement, Hospices Civils de Lyon
Villeurbanne, Lyon, 69100
About this study
Official title: Validation of the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM) and the Ultra-Brief CAM (UB-CAM) in French.
Delirium is very common in hospitalized older patients and associated with serious clinical bad outcomes (e.g. increased risk of functional decline and death). Despite its high prevalence in the hospital setting, delirium remains underdiagnosed. A better identification would allow an early management and a reduction of its complications.
The validation of easy-to-use and quick and formalized tools for the identification of delirium and their implementation in the clinical practice are necessary.
Read more
Recently, the 3D-CAM (3-minutes Diagnostic interview for Confusion Assessment Method -defined delirium) and the UB-CAM (Ultra-Brief CAM) showed very high sensitivity and specificity (> 90%), compared to the reference standard (Diagnostic and Statistical Manual of Mental Disorders (DSM criteria)) for the diagnosis of delirium.
The investigators aimed to evaluate the sensitivity and specificity of the French versions of the 3D-CAM and the UB-CAM used in delirium screening in older adults hospitalized in geriatric units, compared to reference standard.
- Conditions
- Delirium
- Being tested
- Delirium screening using 3D-CAM and UB-CAM
- Keywords
- Delirium, CAM, UB-CAM, 3D-CAM
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delirium screening using 3D-CAM and UB-CAMDiagnostic test
Patients will be evaluated with 3D-CAM and UB-CAM by a trained examiner (geriatrician, resident or neuropsychologist). On the same day, they will be given a reference diagnosis of delirium based on DSM-V criteria by another trained examiner, blind to the results of the UB-CAM and 3D-CAM.
| Study group | Role | What they receive |
|---|---|---|
| Older adults hospitalized in acute geriatric units | Response to a questionnaire Receives: Diagnostic Test: Delirium screening using 3D-CAM and UB-CAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the performance of a rapid diagnostic tool (UB-CAM) for acute confusional state, translated into French
Presence or absence of a confusional state (with UB-CAM and the gold standard: DSM-V criteria)
Measured: At inclusion
Secondary outcomes (2)
Evaluation of the time taken to use this tool
Completion time (minutes, seconds)
Measured: At inclusion
Evaluation of the diagnostic performance of another diagnostic tool (3D-CAM), already translated into French
Presence or absence of a confusional state (with 3D-CAM and the gold standard: DSM-V criteria)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start31 Mar 2022
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine GARNIER-CRUSSARD, MD, MSc, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242887
- Sponsor's protocol ID
- 69HCL21_0903
- Other IDs
- 2021-A02130-41
- Acronym
- French-UB-CAM
- Status last verified
- Apr 2024
- First submitted
- 7 Feb 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM) and the Ultra-Brief CAM (UB-CAM) in French.
- ClinicalTrials.gov ID
- NCT05242887
- Acronym / sponsor ID
- French-UB-CAM / 69HCL21_0903
- Conditions
- Delirium
- Keywords
- Delirium, CAM, UB-CAM, 3D-CAM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 16 Feb 2022 (actual)
- 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.
Delirium is very common in hospitalized older patients and associated with serious clinical bad outcomes (e.g. increased risk of functional decline and death). Despite its high prevalence in the hospital setting, delirium remains underdiagnosed. A better identification would allow an early management and a reduction of its complications.
The validation of easy-to-use and quick and formalized tools for the identification of delirium and their implementation in the clinical practice are necessary.
Recently, the 3D-CAM (3-minutes Diagnostic interview for Confusion Assessment Method -defined delirium) and the UB-CAM (Ultra-Brief CAM) showed very high sensitivity and specificity (> 90%), compared to the reference standard (Diagnostic and Statistical Manual of Mental Disorders (DSM criteria)) for the diagnosis of delirium.
The investigators aimed to evaluate the sensitivity and specificity of the French versions of the 3D-CAM and the UB-CAM used in delirium screening in older adults hospitalized in geriatric units, compared to reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults hospitalized in acute geriatric units | – | Diagnostic Test: Delirium screening using 3D-CAM and UB-CAMResponse to a questionnaire |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults hospitalized in acute geriatric units
Key inclusion criteria (3 listed)
- Adults hospitalized in acute geriatric units
- Aged 65 or older
- Patient (or relative) not objecting to participating in the study
Key exclusion criteria (1 listed)
- Legal protection regimes (guardianship, curatorship)
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 |
|---|---|---|
| Delirium screening using 3D-CAM and UB-CAMPatients will be evaluated with 3D-CAM and UB-CAM by a trained examiner (geriatrician, resident or neuropsychologist). On the same day, they will be given a reference diagnosis of delirium based on DSM-V criteria by another trained examiner, blind to the results of the UB-CAM and 3D-CAM. | Diagnostic test | Older adults hospitalized in acute geriatric units |
Primary outcome
Evaluation of the performance of a rapid diagnostic tool (UB-CAM) for acute confusional state, translated into French
Time frame: At inclusion
Presence or absence of a confusional state (with UB-CAM and the gold standard: DSM-V criteria)
2 secondary outcomes
Evaluation of the time taken to use this tool
Time frame: At inclusion
Evaluation of the diagnostic performance of another diagnostic tool (3D-CAM), already translated into French
Time frame: At inclusion
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 4 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Antoine GARNIER-CRUSSARD, MD, MSc principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 1 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Evaluation of the performance of a rapid diagnostic tool (UB-CAM) for acute confusional state, translated into French (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2024.