Effectiveness of a Community Pharmacy-Based Health Promotion Program on Hypertension in Bangladesh and Pakistan: Study Protocol for a Cluster-Randomized Controlled Trial
Abstract
:1. Introduction
2. Aim and Hypothesis
2.1. Hypothesis
- Reduced systolic and/or diastolic BP;
- Improved treatment adherence and BP control to target levels;
- Reduced hospitalization and death due to cardiovascular events;
- Positive changes in lifestyle behaviors;
- Increased in HRQoL.
2.2. Objectives
3. Methods
3.1. Study Design and Settings
3.2. Study Participants
3.3. Randomization
3.4. Blinding
3.5. Training of the Pharmacists
3.6. Intervention
3.7. Data Collection
- Clinical factors of the patients [time since diagnosis of hypertension in years; types of concomitant antihypertensive medications; development of any hypertension-related complications such as coronary heart disease (CHD), and heart failure and stroke; in the previous six months: (i) occurrence of any adverse health condition related to hypertension requiring hospitalization; (ii) total number of days in hospital following admission; and (iii) total number of visits to doctors for hypertension and its related complication management;
- Organizational information of the community pharmacies (number of visits from hypertensive patients per month in last six months, number of hypertensive cases referred to hospital due to complications in last six months);
- Quality of life measure (EuroQol EQ-5D-5L) [28].
- Blood pressure (lowest of two measurements used);
- Fasting blood glucose level;
- Weight and height;
- Smoking status (options aligned with QRisk2).
3.8. Outcome Evaluation
3.9. Cost-Effectiveness Analysis
3.10. Data Management
3.11. Adverse Event Reporting
3.12. Pilot Study
3.13. Statistical Analysis
3.14. Ethical Approval and Dissemination
4. Discussion
5. Limitations
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Contents | Description | Practical Application | |
---|---|---|---|
1. | Overview of hypertension | The pharmacist will describe the basics of hypertension, the cause of hypertension, the risk factors of hypertension, and common symptoms of hypertension including the current global statistics on it. | Utilizing visual aids and statistics, pharmacists will provide a global perspective on hypertension to enhance patient understanding. |
2. | Complications of hypertension | Pharmacists will describe the common health-related complications of hypertension. | By illustrating potential health outcomes, pharmacists will emphasize the importance of hypertension management. |
3. | Impact of hypertension on family’s healthcare expenditure | The pharmacist will inform the participants how uncontrolled hypertension may increase the disease burden as well as contribute to increasing the total family’s healthcare expenditure. | Through examples and case studies, pharmacists will show the economic impact on families to encourage adherence to treatment plans. |
4. | Management of hypertension | The pharmacist will inform the patients about the general and clinical management of hypertension. | Pharmacists will use guidelines and protocols to educate patients on effective hypertension management practices. |
5. | Importance of lifestyle modification | The pharmacist will discuss lifestyle modifications in hypertension management with the participants, which will include cessation of smoking, reducing alcohol intake, maintaining body weight, reducing and managing mental stress, and performing physical activity regularly. | Interactive sessions and personalized plans will be used to help patients adopt healthier lifestyles. |
6. | Importance of medication adherence | In this part, the pharmacist will advise the participants regarding the consequences of poor adherence to antihypertensive medication and how it reduces the ultimate clinical outcome. | Pharmacists will provide strategies to improve medication adherence, such as setting reminders and creating a medication schedule. |
7. | Importance of food habit on hypertension control | The pharmacist will inform the patients how food habits impact hypertension control, which will include avoiding extra salt consumption in meals, avoiding saturated fat and trans fats, much intake of food and vegetables, etc. | Diet plans and nutritional counseling will be provided to help patients make healthier food choices. |
8. | Importance of regular blood pressure measurement on hypertension control | The pharmacist will suggest to the participants the significance of timely blood pressure monitoring and how it helps a person become more aware of their body. Also, they will suggest how blood pressure measuring assists a doctor in making a quick diagnosis of a health issue. | Demonstrations on how to properly measure BP and track readings will be conducted to empower patients to monitor their health. |
Screening, Enrollment and Randomization | Baseline | Follow-Up | Closed | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Wk 1 | Wk 2 | Wk 3 | Wk 4 | Wk 5 | Month 0 (T1) | Month 3 (T2) | Month 6 (T3) | Month 9 (T4) | Month 12 (T5) | |||
Assessment and intervention | ||||||||||||
Selection criteria | x | x | x | x | ||||||||
Informed consent | x | x | x | x | ||||||||
Randomization | x | |||||||||||
Allocation | x | |||||||||||
Physical examination (Control and intervention group) | ||||||||||||
Blood pressure measurement | x | x | x | |||||||||
BMI | x | x | x | |||||||||
Blood glucose measurement | x | x | x | |||||||||
Baseline characteristics (Control and intervention group) | ||||||||||||
Sociodemographic profile | x | x | x | |||||||||
Dietary habits | x | x | x | |||||||||
Physical exercise habits | x | x | x | |||||||||
Knowledge of hypertension | x | x | x | |||||||||
Direct treatment cost information | x | x | x | |||||||||
Indirect treatment cost information | x | x | x | |||||||||
HRQoL (EuroQoL-5D) | x | x | x | |||||||||
Intervention criteria (Only intervention group) | ||||||||||||
Audio–visual presentation | x | x | ||||||||||
Booklet distribution | x | |||||||||||
Phone call intervention | x | x | ||||||||||
Outcome measurements (Control and intervention group) | ||||||||||||
Primary outcome | ||||||||||||
Change in SBP and DBP | x | x | ||||||||||
Secondary outcome | ||||||||||||
BP controlled to target | x | x | ||||||||||
Composite outcome of death or hospital admission | x | x | ||||||||||
Improvement in knowledge | x | x | ||||||||||
Changes in lifestyle | x | x | ||||||||||
Changes in drug adherence | x | x | ||||||||||
HRQoL gained | x | x | ||||||||||
Cost per unit of BP reduction | x | x | ||||||||||
Cost per HRQoL gained | x | x |
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© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Share and Cite
Rahman, M.M.; Nakamura, R.; Islam, M.M.; Alam, M.A.; Azmat, S.K.; Sato, M. Effectiveness of a Community Pharmacy-Based Health Promotion Program on Hypertension in Bangladesh and Pakistan: Study Protocol for a Cluster-Randomized Controlled Trial. Healthcare 2024, 12, 1402. https://doi.org/10.3390/healthcare12141402
Rahman MM, Nakamura R, Islam MM, Alam MA, Azmat SK, Sato M. Effectiveness of a Community Pharmacy-Based Health Promotion Program on Hypertension in Bangladesh and Pakistan: Study Protocol for a Cluster-Randomized Controlled Trial. Healthcare. 2024; 12(14):1402. https://doi.org/10.3390/healthcare12141402
Chicago/Turabian StyleRahman, Md. Mizanur, Ryota Nakamura, Md. Monirul Islam, Md. Ashraful Alam, Syed Khurram Azmat, and Motohiro Sato. 2024. "Effectiveness of a Community Pharmacy-Based Health Promotion Program on Hypertension in Bangladesh and Pakistan: Study Protocol for a Cluster-Randomized Controlled Trial" Healthcare 12, no. 14: 1402. https://doi.org/10.3390/healthcare12141402
APA StyleRahman, M. M., Nakamura, R., Islam, M. M., Alam, M. A., Azmat, S. K., & Sato, M. (2024). Effectiveness of a Community Pharmacy-Based Health Promotion Program on Hypertension in Bangladesh and Pakistan: Study Protocol for a Cluster-Randomized Controlled Trial. Healthcare, 12(14), 1402. https://doi.org/10.3390/healthcare12141402