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Development of risk score for tuberculosis detection among diabetic patient in Kelantan

Validation and effectiveness of a new screening index (TBDM-PT) for tuberculosis detection among diabetic patients in Kelantan, Malaysia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001221741
Enrollment
50
Registered
2022-09-09
Start date
2022-08-18
Completion date
2022-12-31
Last updated
2022-09-19

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

Conditions

None listed

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.

Interventions

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 coeff

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.

Sponsors

Muhammad Ikhwan Bin Ismail
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

History of DM at least 6 month, 18 years old and above, Not pregnant

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026