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Completed

NCT Number: NCT03366896

Validation Study of the Malay Version of 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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Malay 3D-CAM diagnostic tool 1

Diagnostic Test

Assessor 1 uses Malay 3D-CAM to detect Delirium

Malay 3D-CAM Diagnostic tool 2

Diagnostic Test

Assessor 2 uses Malay 3D-CAM to detect Delirium

Primary outcomes

  1. Construct Validity

    Time frame: 3 months

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

Secondary outcomes

  1. Inter-rater Reliability

    Time frame: 3 months

    Assess the inter-rater reliability of 2 trained assessor using the Malay 3D-CAM

  2. Parallel Reliability

    Time frame: 3 months

    Assess the parallel reliability of using Malay 3D-CAM to the original version of 3D-CAM

  3. Factors associated with post-operative delirium

    Time frame: 3 months

    Assess factors associated with post-operative delirium

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Acronym: VS-MEDCAM

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 8, 2017
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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