Validation Study of the Malay Version of 3D-CAM

NCT03366896 | Completed

• 1 other identifier: MEDCAM1
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Conditions

Postoperative Delirium; Diagnosis, Psychiatric

Outcome Measures

Primary Outcomes (1)

• Construct Validity

  Assess validity of the translated Malay 3D-CAM to Standard Reference for Diagnosis of Delirium

  3 months

Secondary Outcomes (3)

• Inter-rater Reliability

  3 months

• Parallel Reliability

  3 months

• Factors associated with post-operative delirium

  3 months

Study Arms (1)

Delirium

EXPERIMENTAL

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; Diagnostic Test: Malay 3D-CAM Diagnostic tool 2

Interventions

Malay 3D-CAM diagnostic tool 1 DIAGNOSTIC_TEST

Assessor 1 uses Malay 3D-CAM to detect Delirium

Delirium

Malay 3D-CAM Diagnostic tool 2 DIAGNOSTIC_TEST

Assessor 2 uses Malay 3D-CAM to detect Delirium

Delirium

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years old and above
• Patients undergoing non-cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

MeSH Terms

Conditions

Emergence Delirium; Mental Disorders

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders

Study Officials

• Chew Yin Wang, MBChB, FRCA

  Professor University Malaya Anaesthesiology Department

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: December 8, 2017
• Study Start: June 26, 2016
• Primary Completion: September 26, 2016
• Study Completion: September 30, 2016
• Last Updated: December 8, 2017

Record last verified: 2017-12