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临床试验/NCT03366896
NCT03366896已完成不适用

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

University of Malaya0 个研究点目标入组 110 人开始时间: 2016年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
主要终点
Construct Validity

研究概览

简要总结

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.

详细描述

  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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Delirium

Experimental

Diagnosis of delirium according to 5th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by Psychiatrist.

干预措施: Malay 3D-CAM diagnostic tool 1 (Diagnostic Test)

Delirium

Experimental

Diagnosis of delirium according to 5th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by Psychiatrist.

干预措施: Malay 3D-CAM Diagnostic tool 2 (Diagnostic Test)

结局指标

主要结局

Construct Validity

时间窗: 3 months

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

次要结局

  • Factors associated with post-operative delirium(3 months)
  • Inter-rater Reliability(3 months)
  • Parallel Reliability(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chin Yi Zhe

Dr

University of Malaya

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