Validation of the Greek Version of the Confusion Assessment Method Diagnostic Algorithm (CAM) and the Nursing Delirium Screening Scale (Nu-DESC) and Their Inter-rater Reliablity
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|ClinicalTrials.gov Identifier: NCT04154176|
Recruitment Status : Active, not recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
|Condition or disease||Intervention/treatment|
|Postoperative Delirium||Other: CAM, Nu-DESC|
Accurate diagnosis for Greek speaking patients suffering from postoperative delirium is limited by the need for a translation of standardized tools that were investigated for their inter-rater reliability/agreement.
Our primary aim is to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia. Our secondary aim is to estimate the diagnostic accuracy of NuDESK in our population.
This study will provide the first official Greek translation of CAM and Nu-DESC, according to the ISPOR guidelines, and the first evaluation of their inter-rater agreement.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Validation of the Greek Version of the Confusion Assessment Method Diagnostic Algorithm (CAM) and the Nursing Delirium Screening Scale (Nu-DESC) and Their Inter-rater Reliablity: A Prospective Cohort Study|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||December 15, 2019|
POD CAM Nu-DESC
Patients undergoing surgery under general anesthesia assessed for POD with CAM and Nu-DESC
Other: CAM, Nu-DESC
Two trained raters, who are blinded and have no access to each other's evaluation, administer the CAM and Nu-DESC questionnaires in each shift, during the first postoperative day after the discharge from the post-anaesthesia care unit, independently. The two assessments are completed within 60 minutes of each other. If the research team set the diagnosis of POD, the appropriate treatment will be initiated, according to the Hospital's protocol
- Validation of the Greek version of the CAM Diagnostic Algorithm and Nu-DESC [ Time Frame: 1st postoperative day ]validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC
- Estimation of the inter-rater agreement of the Greek versions of the CAM and Nu-DESC [ Time Frame: 1st postoperative day ]estimate the inter-rater agreement of the Greek versions of the CAM and Nu-DESC
- Incidence of POD in our study sample. [ Time Frame: 1st postoperative day ]Estimate the incidence of POD in our study sample.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154176
|Univeristy of Thessaly|
|Larissa, Thessaly, Greece, 41110|
|Study Chair:||Elena Arnaoutoglou, MD, PhD||University of Thessaly|