Validation Study of the Malay Version of 3D-CAM

Postoperative Delirium Clinical Trial

— VS-MEDCAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366896
• Other study ID #: MEDCAM1
• Status: Completed
• Phase: N/A
• First received: December 3, 2017
• Last updated: December 6, 2017
• Start date: June 26, 2016
• Est. completion date: September 30, 2016

Study information

• Verified date: December 2017
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 30, 2016
• Est. primary completion date: September 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Diagnosis, Psychiatric
• Mental Disorders
• Postoperative Delirium

Intervention

Diagnostic Test:
• Malay 3D-CAM diagnostic tool 1
Assessor 1 uses Malay 3D-CAM to detect Delirium
• Malay 3D-CAM Diagnostic tool 2
Assessor 2 uses Malay 3D-CAM to detect Delirium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Construct Validity	Assess validity of the translated Malay 3D-CAM to Standard Reference for Diagnosis of Delirium	3 months
Secondary	Inter-rater Reliability	Assess the inter-rater reliability of 2 trained assessor using the Malay 3D-CAM	3 months
Secondary	Parallel Reliability	Assess the parallel reliability of using Malay 3D-CAM to the original version of 3D-CAM	3 months
Secondary	Factors associated with post-operative delirium	Assess factors associated with post-operative delirium	3 months