NCT04992039

HEARTS Package Evaluation Trial in Bangladesh

Evaluation of the WHO HEARTS Hypertension Control Package in the Primary Care Clinics of Bangladesh: A Quasi-experimental Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,935 (actual)
• Sponsor: National Heart Foundation of Bangladesh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypertension became the leading risk factor of death globally as well as in Bangladesh. Uncontrolled hypertension is the key challenge for the success of a hypertension control programs. According to the last national STEPS Survey in Bangladesh, hypertension control rate is only 11%. World Health Organization promoted the HEARTS technical package for the hypertension control programs to improve the control scenario. National Heart Foundation of Bangladesh is implementing a hypertension control program in selected Upazilas (sub-districts) of Bangladesh in collaboration with Non-Communicable Disease Control (NCDC) Program of Directorate General of Health Services (DGHS) and Resolve to Save Lives, USA. Proposed quasi experimental study will be conducted in collaboration with NCDC of DGHS, Resolve to Save Lives, USA and Johns Hopkins University, Baltimore with an objective of to evaluate the impact of HEARTS package on the rate of hypertension control in primary health care centers in Bangladesh. In this study equal number of hypertensive adult patients will be recruited in Upazila Health Complexes of control and intervention groups with a hypothesis of, implementation of HEARTS technical package in primary health care centers can reduce the blood pressure significantly. After obtaining informed written consent, respondents' basic demographic information, history of antihypertensive medication intake and related comorbidities will be taken. Blood pressure measurements data will be recorded also. All of these data will be collected via a secured mobile application, Simple App. Collected data will be preserved in a secured cloud based database. After six months of enrolment, and end-line data will be collected at the community setup, preferably at the home of respondents, following standard techniques of BP measurement by experienced Field Research Assistants. During whole of the study procedure, every ethical right of the participants will be preserved with an utmost priority. De-identified data will be shared with the partner organizations for further scientific analysis. This study will generate robust evidence for use of HEARTS technical packages in low-and middle-income countries, like Bangladesh, especially at low-level health facilities and provide guidance for designing and implementation of other hypertension control programs.

Conditions

• Hypertension

Interventions

Type	Name	Description
OTHER	WHO HEARTS technical package	Components of WHO HEARTS technical package are 1. Universal BP screening via A\&D arm-in BP device. 2. Training of Medical Officers and Nurses on BP measurement using standard techniques. 3. Training of the nurses on screening, registration data collection via the Simple mobile smart-phone digital clinical hypertension information application. 4. Use of a drug and dose specific hypertension treatment protocol. 5. Standardized inventory and procurement practice to ensure a reliable supply of protocol medications. 6. Training and support for team-based model of hypertension care delivery. 7. Access to the Simple data dashboard for program monitoring. 8. Standardized procedure for patient follow-up. 9. Community-based prescription refilling.

Timeline

• Start date: 2021-10-09
• Primary completion: 2021-12-31
• Completion: 2022-08-12
• First posted: 2021-08-05
• Last updated: 2023-07-14

Locations

14 sites across 1 country: Bangladesh