Clinical trial NCT03366896: Validation Study of the Malay Version of 3D-CAM
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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Diagnosis, Psychiatric
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

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

Primary outcomes:
measure: Construct Validity
timeFrame: 3 months
Secondary outcomes:
measure: Inter-rater Reliability
timeFrame: 3 months
measure: Parallel Reliability
timeFrame: 3 months
measure: Factors associated with post-operative delirium
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor University Malaya Anaesthesiology Department
name: Chew Yin Wang, MBChB, FRCA
role: STUDY_CHAIR
affiliation: Consultant University Malaya Anaesthesiology Department
name: Pui San Loh, MBBS, FANZCA
role: PRINCIPAL_INVESTIGATOR
affiliation: Master Student University Malaya Anaesthesiology Department
name: Yi Zhe Chin, MB BCh, MCAI
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor University Malaya Consultant Psychiatrist
name: Chong Guan Ng, MPM,MSc,PhD
role: PRINCIPAL_INVESTIGATOR
References: