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Validation Study of the Malay Version of 3D-CAM

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03366896
Acronym
VS-MEDCAM
Enrollment
110
Registered
2017-12-08
Start date
2016-06-26
Completion date
2016-09-30
Last updated
2017-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis, Psychiatric, Postoperative Delirium

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.

Interventions

DIAGNOSTIC_TESTMalay 3D-CAM diagnostic tool 1

Assessor 1 uses Malay 3D-CAM to detect Delirium

DIAGNOSTIC_TESTMalay 3D-CAM Diagnostic tool 2

Assessor 2 uses Malay 3D-CAM to detect Delirium

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Construct Validity3 monthsAssess validity of the translated Malay 3D-CAM to Standard Reference for Diagnosis of Delirium

Secondary

MeasureTime frameDescription
Inter-rater Reliability3 monthsAssess the inter-rater reliability of 2 trained assessor using the Malay 3D-CAM
Parallel Reliability3 monthsAssess the parallel reliability of using Malay 3D-CAM to the original version of 3D-CAM
Factors associated with post-operative delirium3 monthsAssess factors associated with post-operative delirium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026