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

NCT05242887 | Completed

• 2 other identifiers: 69HCL21_09032021-A02130-41
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium

Keywords

Delirium; CAM; UB-CAM; 3D-CAM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of the time taken to use this tool

  At inclusion

• Evaluation of the diagnostic performance of another diagnostic tool (3D-CAM), already translated into French

  At inclusion

Study Arms (1)

Older adults hospitalized in acute geriatric units

Response to a questionnaire

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

Interventions

Delirium screening using 3D-CAM and UB-CAM DIAGNOSTIC_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.

Older adults hospitalized in acute geriatric units

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Older adults hospitalized in acute geriatric units

You may qualify if:

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

You may not qualify if:

• \- Legal protection regimes (guardianship, curatorship)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital des Charpennes, Institut du Vieillissement, Hospices Civils de Lyon

Villeurbanne, Lyon, 69100, France

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Antoine GARNIER-CRUSSARD, MD, MSc

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 16, 2022
• Study Start: March 31, 2022
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)