Pneumology - Original Articles
26 June 2025
Early Access
https://doi.org/10.4081/monaldi.2025.3474

Pharmacist-led education intervention to improve pulmonary tuberculosis treatment adherence through the Health Belief Model in Malaysia: a study protocol for a randomized controlled trial

Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Pulmonary tuberculosis, randomized control trial, treatment adherence
0
Views
0
Downloads

Authors

Rabbiya Ahmad
https://orcid.org/0000-0003-0648-6825
Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains, Penang, Malaysia.
Siti Maisharah Sheikh Ghadzi
Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains, Penang, Malaysia.
Irfhan Ali Bin Hyder Ali
Respiratory Clinic, Hospital Pulau Pinang, Penang, Malaysia.
Syed Azhar Syed Sulaiman
Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains, Penang, Malaysia.
Amer Hayat Khan
dramer2006@gmail.com
Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains, Penang, Malaysia.

Pulmonary tuberculosis (TB) remains a significant global health concern, particularly in low- and middle-income countries, where treatment adherence is critical to improving patient outcomes and mitigating drug resistance. In Malaysia, challenges in adherence to TB treatment regimens continue to hinder disease control efforts. This study protocol outlines a pharmacist-led educational intervention to improve treatment adherence among pulmonary TB patients. This randomized controlled trial will enroll 206 pulmonary TB patients from public healthcare facilities in Penang, Malaysia, divided equally into intervention and control groups. The intervention group will receive tailored educational counseling sessions delivered by pharmacists at baseline and during months 2, 4, and 6, using materials developed by the World Health Organization and the Centers for Disease Control TB treatment guidelines. The control group will receive standard care. The pharmacist-led educational intervention will be structured around the Health Belief Model framework to systematically address psychological determinants of adherence. Adherence will be measured using the Medication Adherence Report Scale-5. Data will be collected at baseline and subsequent intervals to assess changes over time. The primary outcome will be to improve the treatment adherence of the pulmonary TB patients. The secondary outcomes will measure knowledge of the TB disease and health-related quality of life. This protocol describes a novel, theory-driven approach to addressing adherence barriers in TB treatment through pharmacist-led education. The study aims to contribute to the global effort to control TB and improve patient outcomes by providing evidence of the intervention's impact.

Altmetrics

Downloads

Download data is not yet available.

Citations

Crossref
Scopus
Google Scholar
Europe PMC
AlOsaimi HM, Alshammari Mk, Almijlad GK, et al. Prevalence, clinical characteristics and determinants of unsuccessful treatment outcomes among pulmonary tuberculosis patients: a 5-year registry-based retrospective cohort study. Patient Relat Outcome Meas 2024:15:187-98.
Ministry of Health Malaysia. National Tuberculosis Registry Report 2023. Available from: https://www.moh.gov.my/.
Zaman MFK, Husain NRN, Sidek MY, Bakar ZA, et al. Determinants of unfavourable treatment outcomes of drug-resistant tuberculosis cases in Malaysia: a case–control study. BMJ Open 2025;15:e093391.
Tshimula JM, alengayi M, Makenga D, et al. Artificial intelligence for public health surveillance in Africa: applications and opportunities. arXiv preprint arXiv:2408.02575.
Sharani ZZ, Ismail N, Yasin SM, et al. Characteristics and determinants of loss to follow-up among tuberculosis (TB) patients who smoke in an industrial state of Malaysia: a registry-based study of the years 2013-2017. BMC Public Health 2022;22:638.
Mehrabizadeh M, Zaremohzzabieh Z, Zarean M, et al. Narratives of resilience: Understanding Iranian breast cancer survivors through health belief model and stress-coping theory for enhanced interventions. BMC Womens Health 2024;24:552.
Kulkarni P, Kulkarni AD, Akarte SV, Rajhans PA. Positive impact of knowledge about tuberculosis and its treatment on treatment adherence among new smear-positive tuberculosis patients in ward E of Mumbai, Maharashtra, India. Int J Educ Psychol Res 2016;2:26.
Tran BX, Bui TM, Do AL, et al. Efficacy of a mobile phone–based intervention on health behaviors and HIV/AIDS treatment management: randomized controlled trial. J Med Internet Res 2023;25:e43432.
Kyei EF, Ansong R, Kyei GK. Integrating nursing practice and policy in opioid overdose prevention: analysis of the opioid‐overdose reduction continuum of care approach practice guide. J Adv Nurs 2025;81:1276-85.
da Silva RD, Tavares de Luna FD, de Araujo AJ, et al. Patients’ perception regarding the influence of individual and social vulnerabilities on the adherence to tuberculosis treatment: a qualitative study. BMC Public Health 2017;17:725.
Zein RA, Suhariadi F, Hendriani W. Estimating the effect of lay knowledge and prior contact with pulmonary TB patients, on health-belief model in a high-risk pulmonary TB transmission population. Psychol Res Behav Manag 2017;10:187-94.
Wong YJ, Thum CC, Ng KY, et al. Engaging community pharmacists in tuberculosis-directly observed treatment: a mixed-methods study. Prim Health Care Res Dev 2023;24:e21.
Ariffin NA, bin Wan Ibrahim WMM, Ibrahim W, Rusian R. Identification of trends, direction of distribution and spatial pattern of tuberculosis disease (2015-2017) in Penang. Geografia 2024;20:68-84.
Uakarn C, Chaokromthong K, Sintao N. Sample size estimation using Yamane and Cochran and Krejcie and Morgan and Green formulas and Cohen statistical power analysis by G* power and comparisons. Apheit Int J 2021;10:76-88.
Narayana G, Kolisetty J, Moses K, Bhupalam P, et al. Impact of pharmacist counselling on knowledge, and medication adherence in tuberculosis patients: a quasi-experimental design. Int J Pharma Bio Sci 2020;10:6-10.
Burugina Nagaraja S, Thekkur P, Satyanarayana S, et al. Active case finding for tuberculosis in India: a syntheses of activities and outcomes reported by the National Tuberculosis Elimination Programme. Trop Med Infect Dis 2021;6:206.
Wong CK, Ng KS, Choo SQR, et al. Factors associated with all-cause mortality in tuberculosis patients in a Malaysian tertiary hospital. J Infect Dev Ctries 2023;17:1138-45.
Saharan VA, Kulhari H, Jadhav HR. Introduction to research methodology. In: Principles of research methodology and ethics in pharmaceutical sciences. Boca Raton, FL, USA: CRC Press; 2020. pp 1-46.
Saidi SS, Abdul Manaf R. Effectiveness of family support health education intervention to improve health-related quality of life among pulmonary tuberculosis patients in Melaka, Malaysia. BMC Pulm Med 2023;23:139.
Rundi C. Understanding tuberculosis: perspectives and experiences of the people of Sabah, East Malaysia. J Health Popul Nutr 2010;28:114-23.
Manoharan A, Farhana HSN, Manimaran K, et al. Facilitators and barriers for tuberculosis preventive treatment among patients with latent tuberculosis infection: a qualitative study. BMC Infect Dis 2023;23:624.
WHO. WHO consolidated guidelines on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment, 2022 update. Available from: https://www.who.int/publications/i/item/9789240063129
WHO. WHO consolidated guidelines on tuberculosis. Module 5: management of tuberculosis in children and adolescents. Available from: https://www.who.int/publications/i/item/9789240046764.
Zimmer AJ, Heitkamp P, Malar J, et al. Facility-based directly observed therapy (DOT) for tuberculosis during COVID-19: a community perspective. J Clin Tuberc Other Mycobact Dis 2021;24:100248.
Spetz K, Olberts T, Östbring M, et al. Using the 5-item medication adherence report scale (MARS-5) to screen for non-adherence to vitamin and mineral supplementation after bariatric surgery. Obes Surg 2024;34:576-82.
Chan AHY, Horne R, Hankins M, Chisari C. The medication adherence report scale: a measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol 2020;86:1281-8.
Zakaria R, Zahiruddin WM, Husain NRN, et al. Development and validation of a new knowledge, attitude, practice and stigma questionnaire on tuberculosis in Malaysia. Malaysian J Public Health Med 2023;23:64-75.
Zhou T, Guan H, Wang L, et al. Health-related quality of life in patients with different diseases measured with the EQ-5D-5L: a systematic review. Front Public Health 2021;9:675523.
White NM, Balasubramaniam T, Nayak R, Barnettet AG. An observational analysis of the trope “A p-value of< 0.05 was considered statistically significant” and other cut-and-paste statistical methods. PLoS One 2022;17:e0264360.

Ethics Approval

The ethical study approval is obtained from the hospital and the Medical Research & Ethics Committee (MREC) under the Malaysian Ministry of Health, with reference numbers NMRR ID-22-01964-WWH (IIR) and Jawatankuasa Etika Penyelidikan Manusia USM (JEPeM) from Universiti Sains Malaysia JePEM: USM/JEPeM/PP/23120985.

How to Cite



“Pharmacist-Led Education Intervention to Improve Pulmonary Tuberculosis Treatment Adherence through the Health Belief Model in Malaysia: A Study Protocol for a Randomized Controlled Trial”. 2025. Monaldi Archives for Chest Disease, June. https://doi.org/10.4081/monaldi.2025.3474.
Copyright (c) 2025 The Author(s) Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.