Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001221741
Ethics application status
Approved
Date submitted
21/08/2022
Date registered
9/09/2022
Date last updated
9/09/2022
Date data sharing statement initially provided
9/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of risk score for tuberculosis detection among diabetic patient in Kelantan
Scientific title
Validation and effectiveness of a new screening index (TBDM-PT) for tuberculosis detection among diabetic patients in Kelantan, Malaysia
Secondary ID [1] 307818 0
NMRR ID-22-01292-8YZ
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 327415 0
Diabetes Mellitus 327416 0
Condition category
Condition code
Public Health 324544 324544 0 0
Health service research
Respiratory 324587 324587 0 0
Other respiratory disorders / diseases
Infection 324588 324588 0 0
Other infectious diseases
Metabolic and Endocrine 324663 324663 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 district randomly selected in Kelantan, Malaysia for Intervention and control group

Tuberculosis Diabetes Mellitus Predictive Tool (TBDM-PT) developed from the analysis of secondary data (Patient Medical record) and literature review to find the associated factor risk of TB among diabetic patient which subsequently undergone content and face validation. It may contain 4-5 simple question including sociodemograph, glycemic control and scoring point for each variable included base on Beta coefficient from significant factor from Multiple logistic regression and highest coverage of Area Under Curve (AUC) graph. From the AUC we can determine either the participant categorize as low or high risk.

For Intervention group, Patient with history of DM for at least 6 month will be screened with the Tuberculosis Diabetic Mellitus Predictive Tool (TBDM-PT).
Intervention use in this study using the Tuberculosis Diabetic Mellitus Predictive Tool (TBDM-PT) develop to triage risk of Tuberculosis (TB) either high risk or low risk among DM patient and subsequently proceed to standard available diagnostic testing including Chest X-Ray,Acid Fast Bacilli (AFB) sputum and Tuberculin skin test (TST). The risk score will be calculated by a trained staff using pre-existing information on medical records (after patient consent) and therefore will not directly involve any participant time. It only take about 10-15 minutes for each assessment using the pre-existing information.
The triaging will be done by trained health care staff at selected government health clinic for a Diabetic Clinic walk-in patient. Based on the risk score, patient may be categorized either high risk or low risk. Once the score obtained, It will be provided to the nurse immediately after the consultation for diagnostic test appointment.
The dedicated health care staff will arrange a TB diagnostic test as stated above for high risk patient and the data will be included in study analysis. Meanwhile the low risk will proceeded to current TB screening program and will be exclude from study analysis.

To ensure the adherence to the intervention, verbal confirmation from patient is required and patient will be contacted by health staff after 1 month if not come for diagnostic test as scheduled.
Intervention code [1] 324286 0
Early detection / Screening
Comparator / control treatment

For a control group, anyone with history of Diabetes Mellitus (DM) at least 6 month will be proceeded to TB diagnostic test including Chest X-Ray,Acid Fast Bacilli (AFB) sputum and Tuberculin skin test (TST). All sample in control group will included in study analysis. They will not be screen by the TBDM-PT. Basically the control group is using the current standard TB screening among DM patient.
Control group
Active

Outcomes
Primary outcome [1] 332366 0
TB disease detection among Diabetic Patients using composite results from Chest X-Ray, Acid Fast Bacilli (AFB) sputum. For TB disease detection among Diabetic Patients , information will be collected by data-linkage to medical records which been recorded by a trained health care staff
Timepoint [1] 332366 0
At 4 month of randomization of the district
Secondary outcome [1] 413204 0
Latent Tuberculosis (TB) Infection detection among Diabetic Patients using result from the Tuberculin skin test. Information will be collected by data-linkage to medical records which been recorded by a trained health care staff
Timepoint [1] 413204 0
At 4 month of randomization of the district

Eligibility
Key inclusion criteria
History of DM at least 6 month, 18 years old and above, Not pregnant
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures using coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/08/2022
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
500
Accrual to date
50
Final
Recruitment outside Australia
Country [1] 24969 0
Malaysia
State/province [1] 24969 0
Kelantan

Funding & Sponsors
Funding source category [1] 312090 0
University
Name [1] 312090 0
Universiti Sains Malaysia
Country [1] 312090 0
Malaysia
Primary sponsor type
Individual
Name
Muhammad Ikhwan Bin Ismail
Address
Community Medicine Department,
School of Science Medicine,
Universiti Sains Malaysia
16150 Kubang Kerian, Kelantan
Country
Malaysia
Secondary sponsor category [1] 313610 0
Individual
Name [1] 313610 0
Wan Mohd Zahirudin Bin Wan Mohammad
Address [1] 313610 0
Community Medicine Department,
School of Science Medicine,
Universiti Sains Malaysia
16150 Kubang Kerian, Kelantan
Country [1] 313610 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311495 0
Malaysia Medical Research & Ethics Committee
Ethics committee address [1] 311495 0
National Institute of Health (NIH)
No.1, Jalan Setia Murni U13/52,
Seksyen U13 Bandar Setia Alam,
40170 Shah Alam, Selangor.
Ethics committee country [1] 311495 0
Malaysia
Date submitted for ethics approval [1] 311495 0
05/06/2022
Approval date [1] 311495 0
18/08/2022
Ethics approval number [1] 311495 0
NMRR ID-22-01292-8YZ (IIR)

Summary
Brief summary
This study is related to Tuberculosis (TB) and validation of TB risk scoring for diabetics in Kelantan, Malaysia. TB case detection activity is still low among Diabetic patients. In addition, there was no screening tool specifically developed for TB detection among diabetic patient.

The purpose of this study is to Develop and determine the effectiveness of Tuberculosis Diabetes Mellitus Predictive Tool (TBDM-PT) in improving TB screening uptake and case detection. The criteria in the develop tools may include sociodermographic data and glycemic control that may increase the risk of developing TB.

By developing the risk score known as Tuberculosis Diabetes Mellitus Predictive Tool (TBDM-PT) may provide a guide for triaging any Diabetic patient to determine weather they are low or high risk for Tuberculosis (TB) before proceeded to diagnostic test.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121302 0
Dr Muhammad Ikhwan Bin Ismail
Address 121302 0
Community Medicine Department,
School of Science Medicine,
Universiti Sains Malaysia
16150 Kubang Kerian, Kelantan
Country 121302 0
Malaysia
Phone 121302 0
+60193822899
Fax 121302 0
Email 121302 0
drikhwan@student.usm.my
Contact person for public queries
Name 121303 0
Dr Muhammad Ikhwan Bin Ismail
Address 121303 0
Community Medicine Department,
School of Science Medicine,
Universiti Sains Malaysia
16150 Kubang Kerian, Kelantan
Country 121303 0
Malaysia
Phone 121303 0
+60193822899
Fax 121303 0
Email 121303 0
drikhwan@student.usm.my
Contact person for scientific queries
Name 121304 0
Dr Muhammad Ikhwan Bin Ismail
Address 121304 0
Community Medicine Department,
School of Science Medicine,
Universiti Sains Malaysia
16150 Kubang Kerian, Kelantan
Country 121304 0
Malaysia
Phone 121304 0
+60193822899
Fax 121304 0
Email 121304 0
drikhwan@student.usm.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval only allow to be use by researcher and not for publicly available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.