Back to resultsTranslation and Validation of the French Version of Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Primary Purpose
Patients With Mental Confusion
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CAM-ICU.fr
Sponsored by
About this trial
This is an interventional diagnostic trial for Patients With Mental Confusion
Eligibility Criteria
Inclusion Criteria:
- Adult, > or equal to 18-yr
- Richmond Agitation Sedation Scale (RASS) > or equal -3
- Francophone
Exclusion Criteria:
- Diagnostic of cognitive disorders
- Admission for brain injury
- Psychotic disorders
- Diagnostic of cognitive disorders
- Visual or auditory impairments
Sites / Locations
- Centre Hospitalier Universitaire Montpellier, Saint Eloi
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CAM-ICU.fr
Arm Description
CAM-ICU and ICDSC evaluation proceed by two investigators and a Neuropsychologist (Speech & language therapist specialized in neuropsychology)
Outcomes
Primary Outcome Measures
Statistical criteria of performance (sensibility, specificity, negative predictive value, positive predictive value) of Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) compared to gold standard (neuropsychologist).
Investigators team: evaluation by the CAM- ICU in French and Intensive Care Delirium Screening Check list (ICDSC) during 2 minutes for the concomitant CAM- ICU and ICDSC , carried out at 30 minutes intervals by two Clinical Research Nurse of the investigative team .
The neuropsychologist will do the evaluation according to criteria common DSM5. Neuropsychologists now used DSM 5 criteria to diagnose delirium at our institution since new DSM 5 criteria have been published in French.
Secondary Outcome Measures
Inter-rater reliability, comparison to Intensive Care Delirium Screening Checklist and standard bedside practices
Statistics ICDSC criteria will be assessed against the Gold Standard . The reproducibility of the CAM- ICU and ICDSC will be evaluated according to different inter-observer.
Full Information
NCT ID
NCT02760446
First Posted
December 22, 2015
Last Updated
November 17, 2016
Sponsor
University Hospital, Montpellier
Collaborators
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT02760446
Brief Title
Translation and Validation of the French Version of Confusion Assessment Method for the Intensive Care Unit
Acronym
CAM-ICU
Official Title
Validation of the French Confusion Assessment Method for the Intensive Care Unit Among Adult ICU Patient
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Validity and Reliability of French Version of the Confusion Assessment Method for the Intensive Care Unit (psychometric validation study after translation/back translation process assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Mental Confusion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAM-ICU.fr
Arm Type
Other
Arm Description
CAM-ICU and ICDSC evaluation proceed by two investigators and a Neuropsychologist (Speech & language therapist specialized in neuropsychology)
Intervention Type
Behavioral
Intervention Name(s)
CAM-ICU.fr
Intervention Description
Neuropsychological testing
Primary Outcome Measure Information:
Title
Statistical criteria of performance (sensibility, specificity, negative predictive value, positive predictive value) of Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) compared to gold standard (neuropsychologist).
Description
Investigators team: evaluation by the CAM- ICU in French and Intensive Care Delirium Screening Check list (ICDSC) during 2 minutes for the concomitant CAM- ICU and ICDSC , carried out at 30 minutes intervals by two Clinical Research Nurse of the investigative team .
The neuropsychologist will do the evaluation according to criteria common DSM5. Neuropsychologists now used DSM 5 criteria to diagnose delirium at our institution since new DSM 5 criteria have been published in French.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Inter-rater reliability, comparison to Intensive Care Delirium Screening Checklist and standard bedside practices
Description
Statistics ICDSC criteria will be assessed against the Gold Standard . The reproducibility of the CAM- ICU and ICDSC will be evaluated according to different inter-observer.
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult, > or equal to 18-yr
Richmond Agitation Sedation Scale (RASS) > or equal -3
Francophone
Exclusion Criteria:
Diagnostic of cognitive disorders
Admission for brain injury
Psychotic disorders
Diagnostic of cognitive disorders
Visual or auditory impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GERALD CHANQUES, MD,Ph.D
Organizational Affiliation
University of Montpellier Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Montpellier, Saint Eloi
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Translation and Validation of the French Version of Confusion Assessment Method for the Intensive Care Unit
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