Validation Study of the Malay Version of 3D-CAM (VS-MEDCAM)
Primary Purpose
Postoperative Delirium, Diagnosis, Psychiatric
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Malay 3D-CAM diagnostic tool 1
Malay 3D-CAM Diagnostic tool 2
Sponsored by
About this trial
This is an interventional diagnostic trial for Postoperative Delirium
Eligibility Criteria
Inclusion Criteria:
- Age 65 years old and above
- Patients undergoing non-cardiac surgery
Exclusion Criteria:
- Patients undergoing cardiac Surgery
- Unable to communicate in the Malay Language
- Patients who were in the intensive care unit peri-operatively
- Patients whose surgery was cancelled
- Patients who were deaf and dumb
- Patients who had been diagnosed as delirious or has psychosis history before assessment
- Glasgow Coma Scale of < 12 / 15
- Patients who remained comatose throughout the investigation
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Delirium
Arm Description
Diagnosis of delirium according to 5th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by Psychiatrist.
Outcomes
Primary Outcome Measures
Construct Validity
Assess validity of the translated Malay 3D-CAM to Standard Reference for Diagnosis of Delirium
Secondary Outcome Measures
Inter-rater Reliability
Assess the inter-rater reliability of 2 trained assessor using the Malay 3D-CAM
Parallel Reliability
Assess the parallel reliability of using Malay 3D-CAM to the original version of 3D-CAM
Factors associated with post-operative delirium
Assess factors associated with post-operative delirium
Full Information
NCT ID
NCT03366896
First Posted
December 3, 2017
Last Updated
December 6, 2017
Sponsor
University of Malaya
1. Study Identification
Unique Protocol Identification Number
NCT03366896
Brief Title
Validation Study of the Malay Version of 3D-CAM
Acronym
VS-MEDCAM
Official Title
Validation Study of the Malay Version of the 3-Minute Diagnostic Interview for Confusion Assessment Method Defined Delirium (3D-CAM)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 26, 2016 (Actual)
Primary Completion Date
September 26, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Validation of the Malay version of 3D-CAM, involving two-staged process.
Translation and cultural adaptation of 3D-CAM into the Malay language.
Testing for Validity and Reliability of the translated 3D-CAM tool to detect postoperative delirium.
Detailed Description
Translation and Cultural Adaptation
The research panel, who consisted of experts in the clinical field of anesthesia, did the meticulous process of translation and cultural adaptation of 3D-CAM.
This process included independent translation by the research panel, reconciliation of two independent translated 3D-CAM, ethics approval prior to pilot study on 20 relevant subjects, back translation into English and finalizing the Malay version of 3D-CAM for the next phase of testing.
Testing for Validity and Reliability of the translated 3D-CAM tool
Patients were recruited pre-operatively after reading the patient's information sheet and signing the informed consent.
Post-operatively, two trained assessors separately administered the Malay 3D-CAM on the recruited patients. One of the trained assessors administered the original 3D-CAM on the same patients at a different time. Standard reference of diagnosing delirium was made by a psychiatrist using the DSM V criteria, after interviewing the patients.
For validity, the diagnosis of delirium made using the Malay 3D-CAM tool was tested against the standard reference for diagnosing delirium according to the DSM V criteria made by a psychiatrist
For inter-rater reliability, the diagnosis of delirium made by two trained assessors using the Malay 3D-CAM tool were statistically compared.
For parallel reliability, the diagnosis of delirium made using the Malay 3D-CAM was compared to the original English version of 3D-CAM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium, Diagnosis, Psychiatric
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delirium
Arm Type
Experimental
Arm Description
Diagnosis of delirium according to 5th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by Psychiatrist.
Intervention Type
Diagnostic Test
Intervention Name(s)
Malay 3D-CAM diagnostic tool 1
Intervention Description
Assessor 1 uses Malay 3D-CAM to detect Delirium
Intervention Type
Diagnostic Test
Intervention Name(s)
Malay 3D-CAM Diagnostic tool 2
Intervention Description
Assessor 2 uses Malay 3D-CAM to detect Delirium
Primary Outcome Measure Information:
Title
Construct Validity
Description
Assess validity of the translated Malay 3D-CAM to Standard Reference for Diagnosis of Delirium
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Inter-rater Reliability
Description
Assess the inter-rater reliability of 2 trained assessor using the Malay 3D-CAM
Time Frame
3 months
Title
Parallel Reliability
Description
Assess the parallel reliability of using Malay 3D-CAM to the original version of 3D-CAM
Time Frame
3 months
Title
Factors associated with post-operative delirium
Description
Assess factors associated with post-operative delirium
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 65 years old and above
Patients undergoing non-cardiac surgery
Exclusion Criteria:
Patients undergoing cardiac Surgery
Unable to communicate in the Malay Language
Patients who were in the intensive care unit peri-operatively
Patients whose surgery was cancelled
Patients who were deaf and dumb
Patients who had been diagnosed as delirious or has psychosis history before assessment
Glasgow Coma Scale of < 12 / 15
Patients who remained comatose throughout the investigation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chew Yin Wang, MBChB, FRCA
Organizational Affiliation
Professor University Malaya Anaesthesiology Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pui San Loh, MBBS, FANZCA
Organizational Affiliation
Consultant University Malaya Anaesthesiology Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi Zhe Chin, MB BCh, MCAI
Organizational Affiliation
Master Student University Malaya Anaesthesiology Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chong Guan Ng, MPM,MSc,PhD
Organizational Affiliation
Associate Professor University Malaya Consultant Psychiatrist
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual responses from the Malay 3D-CAM
Learn more about this trial
Validation Study of the Malay Version of 3D-CAM
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