Postoperative DeliriumVS-MEDCAMNCT03366896
Validation Study of the Malay Version of 3D-CAM
A study testing Malay 3D-CAM diagnostic tool 1 and Malay 3D-CAM Diagnostic tool 2 in people with Postoperative Delirium and Diagnosis, Psychiatric, run by University of Malaya.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Diagnosis, Psychiatric
- What is being tested?
- Malay 3D-CAM diagnostic tool 1 and Malay 3D-CAM Diagnostic tool 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2016to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years old and above
- Patients undergoing non-cardiac surgery
Who cannot join
- 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
About this study
Official title: Validation Study of the Malay Version of the 3-Minute Diagnostic Interview for Confusion Assessment Method Defined Delirium (3D-CAM)
Validation of the Malay version of 3D-CAM, involving two-staged process.
- Translation and cultural adaptation of 3D-CAM into the Malay language.
- Testing for Validity and Reliability of the translated 3D-CAM tool to detect postoperative delirium.
Read the detailed description
- 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.
- Conditions
- Postoperative Delirium, Diagnosis, Psychiatric
- Being tested
- Malay 3D-CAM diagnostic tool 1, Malay 3D-CAM Diagnostic tool 2
- Medical subject headings
- Emergence Delirium, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malay 3D-CAM diagnostic tool 1Diagnostic test
Assessor 1 uses Malay 3D-CAM to detect Delirium
Malay 3D-CAM Diagnostic tool 2Diagnostic test
Assessor 2 uses Malay 3D-CAM to detect Delirium
| Study group | Role | What they receive |
|---|---|---|
| Delirium | Experimental | Diagnosis of delirium according to 5th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by Psychiatrist. Receives: Diagnostic Test: Malay 3D-CAM diagnostic tool 1; Diagnostic Test: Malay 3D-CAM Diagnostic tool 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct Validity
Assess validity of the translated Malay 3D-CAM to Standard Reference for Diagnosis of Delirium
Measured: 3 months
Secondary outcomes (3)
Inter-rater Reliability
Assess the inter-rater reliability of 2 trained assessor using the Malay 3D-CAM
Measured: 3 months
Parallel Reliability
Assess the parallel reliability of using Malay 3D-CAM to the original version of 3D-CAM
Measured: 3 months
Factors associated with post-operative delirium
Assess factors associated with post-operative delirium
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start26 Jun 2016
- Primary completion26 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Yi Zhe, University of Malaya
- Investigators
- Chew Yin Wang, MBChB, FRCA, Study chair, Professor University Malaya Anaesthesiology DepartmentPui San Loh, MBBS, FANZCA, Principal investigator, Consultant University Malaya Anaesthesiology DepartmentYi Zhe Chin, MB BCh, MCAI, Principal investigator, Master Student University Malaya Anaesthesiology DepartmentChong Guan Ng, MPM,MSc,PhD, Principal investigator, Associate Professor University Malaya Consultant Psychiatrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366896
- Sponsor's protocol ID
- MEDCAM1
- Acronym
- VS-MEDCAM
- Status last verified
- Dec 2017
- First submitted
- 3 Dec 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual responses from the Malay 3D-CAM
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of the Malay Version of the 3-Minute Diagnostic Interview for Confusion Assessment Method Defined Delirium (3D-CAM)
- ClinicalTrials.gov ID
- NCT03366896
- Acronym / sponsor ID
- VS-MEDCAM / MEDCAM1
- Conditions
- Postoperative Delirium, Diagnosis, Psychiatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 26 Jun 2016 (actual)
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validation of the Malay version of 3D-CAM, involving two-staged process.
- Translation and cultural adaptation of 3D-CAM into the Malay language.
- Testing for Validity and Reliability of the translated 3D-CAM tool to detect postoperative delirium.
Detailed description
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delirium | Experimental | Diagnostic Test: Malay 3D-CAM diagnostic tool 1, Diagnostic Test: Malay 3D-CAM Diagnostic tool 2Diagnosis of delirium according to 5th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by Psychiatrist. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years old and above
- Patients undergoing non-cardiac surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Malay 3D-CAM diagnostic tool 1Assessor 1 uses Malay 3D-CAM to detect Delirium | Diagnostic test | Delirium |
| Malay 3D-CAM Diagnostic tool 2Assessor 2 uses Malay 3D-CAM to detect Delirium | Diagnostic test | Delirium |
Primary outcome
Construct Validity
Time frame: 3 months
Assess validity of the translated Malay 3D-CAM to Standard Reference for Diagnosis of Delirium
3 secondary outcomes
Inter-rater Reliability
Time frame: 3 months
Parallel Reliability
Time frame: 3 months
Factors associated with post-operative delirium
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Individual participant dataSharing planned: Undecided. Individual responses from the Malay 3D-CAM
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chew Yin Wang, MBChB, FRCA study chair
Professor University Malaya Anaesthesiology Department
Pui San Loh, MBBS, FANZCA principal investigator
Consultant University Malaya Anaesthesiology Department
Yi Zhe Chin, MB BCh, MCAI principal investigator
Master Student University Malaya Anaesthesiology Department
Questions about this trial
What is this clinical trial studying?
A study testing Malay 3D-CAM diagnostic tool 1 and Malay 3D-CAM Diagnostic tool 2 in people with Postoperative Delirium and Diagnosis, Psychiatric, run by University of Malaya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct Validity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.