Validation Study of the Malay Version of 3D-CAM (VS-MEDCAM)

Validation Study of the Malay Version of the 3-Minute Diagnostic Interview for Confusion Assessment Method Defined Delirium (3D-CAM)

Validation of the Malay version of 3D-CAM, involving two-staged process.

1. Translation and cultural adaptation of 3D-CAM into the Malay language.
2. Testing for Validity and Reliability of the translated 3D-CAM tool to detect postoperative delirium.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Diagnosis, Psychiatric
• Intervention / Treatment: Diagnostic test: Malay 3D-CAM diagnostic tool 1; Diagnostic test: Malay 3D-CAM Diagnostic tool 2

Detailed Description

1. 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.

2. 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.

1. 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
2. For inter-rater reliability, the diagnosis of delirium made by two trained assessors using the Malay 3D-CAM tool were statistically compared.
3. For parallel reliability, the diagnosis of delirium made using the Malay 3D-CAM was compared to the original English version of 3D-CAM.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Delirium; Diagnosis of delirium according to 5th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by Psychiatrist.	Diagnostic test: Malay 3D-CAM diagnostic tool 1; Assessor 1 uses Malay 3D-CAM to detect Delirium; Diagnostic test: Malay 3D-CAM Diagnostic tool 2; Assessor 2 uses Malay 3D-CAM to detect Delirium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Construct Validity	Assess validity of the translated Malay 3D-CAM to Standard Reference for Diagnosis of Delirium	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-rater Reliability	Assess the inter-rater reliability of 2 trained assessor using the Malay 3D-CAM	3 months
Parallel Reliability	Assess the parallel reliability of using Malay 3D-CAM to the original version of 3D-CAM	3 months
Factors associated with post-operative delirium	Assess factors associated with post-operative delirium	3 months

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Study Chair: Chew Yin Wang, MBChB, FRCA, Professor University Malaya Anaesthesiology Department; Principal Investigator: Pui San Loh, MBBS, FANZCA, Consultant University Malaya Anaesthesiology Department; Principal Investigator: Yi Zhe Chin, MB BCh, MCAI, Master Student University Malaya Anaesthesiology Department; Principal Investigator: Chong Guan Ng, MPM,MSc,PhD, Associate Professor University Malaya Consultant Psychiatrist

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2016
• Primary Completion (ACTUAL): September 26, 2016
• Study Completion (ACTUAL): September 30, 2016

Study Registration Dates

• First Submitted: December 3, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (ACTUAL): December 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Mental Disorders
• Other Study ID Numbers: MEDCAM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual responses from the Malay 3D-CAM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No