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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
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 3, 2017
    Last Updated
    December 6, 2017
    Sponsor
    University of Malaya
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    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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