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Validation of the 3D-CAM Turkish Version

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04853706
Recruitment Status : Not yet recruiting
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
SINEM SARI, Aydin Adnan Menderes University

Study Description
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Brief Summary:

3D CAM into Turkish validity and reliability on postoperative delirium will be test as a prospective diagnostic study. After approval by Dr. Edward R. Marcantonio, (15) will translation and back-translation. The original 3D-CAM will translate into Turkish by two medical doctor .The two translational versions will be discussed and merged into a final version. Back translation will performed in regardless of any information from its original version by another two medical doctor. Both the translated and back translated versions will sent to Dr. Marcantonio for approval. Eligibility and the documentation of consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and historical medical information, including information regarding medication usage. The Mini-Mental State Exam (MMSE) will be performed.

Delirium assessment

Delirium assessment with the 3D-CAM Before the study period, all researchers will participate online training program on 3D CAM. Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days.

Delirium assessment with the DSM-5 The psychiatrist investigator who was blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.


Condition or disease Intervention/treatment Phase
Delirium Validity Diagnostic Test: 3d cam Diagnostic Test: DSM 5 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Validation of the 3D-CAM Turkish Version in Surgical ICU Patients
Estimated Study Start Date : April 18, 2021
Estimated Primary Completion Date : October 18, 2021
Estimated Study Completion Date : December 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arms and Interventions
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Arm Intervention/treatment
Delirium Diagnostic Test: 3d cam
The 3D-CAM is a short interview that uses verbal responses and allows completion of the Confusion Assessment Method (CAM) diagnostic algorithm

Diagnostic Test: DSM 5
The DSM-5 is the gold standard for diagnosing delirium. But proper use requires professional psychiatric background and training.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of delirium [ Time Frame: 3 days ]
    Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days. The psychiatrist investigator who will be blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • ASA Physical Status 1-3
  • Admitted to the ICU after surgery with a predicted length of stay for more than 48 h
  • MMSE ≥ 20 (to exclude dementia)

Exclusion Criteria:

  • Refused to participate
  • Patients with severe visual or auditory disorder/handicaps or endotracheal intubation which might impede communication
  • Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, Alzheimer or dementia, Parkinsonism
  • Deep sedation or coma
  • ASA physical status IV or V
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04853706


Contacts
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Contact: SINEM S OZTURK 4441256 sarisinem@yahoo.com

Sponsors and Collaborators
Aydin Adnan Menderes University
More Information
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Publications:

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Responsible Party: SINEM SARI, Assoc Prof, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT04853706    
Other Study ID Numbers: 2021/28
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders