Validation of the 3D-CAM and the UB-CAM in French

Delirium Clinical Trial

— French-UB-CAM  

Official title:

Validation of the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM) and the Ultra-Brief CAM (UB-CAM) in French.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242887
• Other study ID #: 69HCL21_0903
• Secondary ID: 2021-A02130-41
• Status: Completed
• Start date: March 31, 2022
• Est. completion date: March 27, 2024

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 27, 2024
• Est. primary completion date: March 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Adults hospitalized in acute geriatric units
• Aged 65 or older
• Patient (or relative) not objecting to participating in the study

Exclusion Criteria:

• Legal protection regimes (guardianship, curatorship)

Related Conditions & MeSH terms

• Delirium

Intervention

Diagnostic Test:
• Delirium screening using 3D-CAM and UB-CAM
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.

Locations

Country	Name	City	State
France	Hôpital des Charpennes, Institut du Vieillissement, Hospices Civils de Lyon	Villeurbanne	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At inclusion
Secondary	Evaluation of the time taken to use this tool	Completion time (minutes, seconds)	At inclusion
Secondary	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)	At inclusion