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Completed

NCT Number: NCT05242887

Validation of the 3D-CAM and the 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.

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Villeurbanne, Lyon, 69100, France

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Evaluation of the time taken to use this tool

    Time frame: At inclusion

    Completion time (minutes, seconds)

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

    Time frame: At inclusion

    Presence or absence of a confusional state (with 3D-CAM and the gold standard: DSM-V criteria)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: French-UB-CAM

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2022
Registry last updated
Apr 4, 2024

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.

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