Clinical trial NCT04992039: HEARTS Package Evaluation Trial in Bangladesh
Official title: Evaluation of the WHO HEARTS Hypertension Control Package in the Primary Care Clinics of Bangladesh: A Quasi-experimental Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: High Blood Pressure
Hypertension
Hypertension Control Program
World Health Organization HEARTS Technical Package
Lead sponsor: National Heart Foundation of Bangladesh
Sponsor class: OTHER
Collaborators: name: Resolve to Save Lives
name: National Heart Foundation Hospital and Research Institute, Bangladesh
name: Non-communicable Disease Control Programme, Directorate General of Health Services, Bangladesh
name: Johns Hopkins University
First posted: 2021-08-05
Enrollment: 3935
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Equal number of participants will be recruited simultaneously in both group of control and intervention. After certain time period of intervention participants of both groups will be evaluated and the differences of outcome will be measured.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Aged 18 and above
* Have a diagnosis of hypertension (inclusive of known prior diagnosis or a new diagnosis), with a baseline systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg
* Eligible for the HEARTS technical package, i.e., are not pregnant, not being treated for an acute illness or medical emergency, and do not have a terminal illness.

Exclusion Criteria:

* Previously diagnosed hypertensive patients with a controlled BP at the time of enrollment (systolic BP \<140 mmHg and diastolic BP \< 90 mmHg). Either BP is controlled using diet and lifestyle measures or BP is controlled on antihypertensive medications,
* Cognitive impairment that would prevent comprehension of and responding to questions
* Patients who otherwise meet inclusion criteria but decline to participate in the hypertension program evaluation or are not able to give written informed consent.

Primary outcomes:
measure: Difference in differences of systolic blood pressure (SBP)
timeFrame: Six months
Secondary outcomes:
measure: Difference in differences of diastolic blood pressure (DBP)
timeFrame: Six months
measure: Difference in differences of rate of hypertension control.
timeFrame: Six months
measure: Rate of loss to follow-up.
timeFrame: Six months
measure: Difference in differences of rate of hypertension control (Measured in the clinic)
timeFrame: Six months
measure: Rate of loss to follow up
timeFrame: Six months
measure: Difference in time to BP control
timeFrame: Six months
Other outcomes:
Locations:
city: Jamalpur
country: Bangladesh
facility: Madarganj Upazila Health Complex
state: Dhaka
city: Habiganj
country: Bangladesh
facility: Baniachang Upazila Health Complex
city: Habiganj
country: Bangladesh
facility: Madhabpur Upazila Health Complex
city: Jamalpur
country: Bangladesh
facility: Bakhshiganj Upazila Health Complex
city: Jamalpur
country: Bangladesh
facility: Dewanganj Upazila Health Complex
city: Jamalpur
country: Bangladesh
facility: Islampur Upazila Health Complex
city: Jamalpur
country: Bangladesh
facility: Melandaha Upazila Health Complex
city: Jamalpur
country: Bangladesh
facility: Sarishabari Upazila Health Complex
city: Kishoreganj
country: Bangladesh
facility: Karimganj Upazila Health Complex
city: Kishoreganj
country: Bangladesh
facility: Katiadi Upazila Health Complex
city: Kishoreganj
country: Bangladesh
facility: Tarail Upazila Health Complex
city: Sunamganj
country: Bangladesh
facility: Biswamvarpur Upazila Health Complex
city: Sunamganj
country: Bangladesh
facility: Doarabajar Upazila Health Complex
city: Sylhet
country: Bangladesh
facility: Gowainghat Upazila Health Complex
Study officials:
affiliation: National Heart Foundation Hospital and Research Institute
name: Sohel R Choudhury, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mills KT, Bundy JD, Kelly TN, Reed JE, Kearney PM, Reynolds K, Chen J, He J. Global Disparities of Hypertension Prevalence and Control: A Systematic Analysis of Population-Based Studies From 90 Countries. Circulation. 2016 Aug 9;134(6):441-50. doi: 10.1161/CIRCULATIONAHA.115.018912.
citation: Kaur P, Kunwar A, Sharma M, Mitra J, Das C, Swasticharan L, Chakma T, Dipak Bangar S, Venkatasamy V, Dharamsoth R, Purohit S, Tayade S, Singh GB, Bitragunta S, Durgad K, Das B, Dar S, Bharadwaj R, Joshi C, Bharadwaj V, Khedkar S, Chenji S, Reddy SK, Sreedhar C, Parasuraman G, Kasiviswanathan S, Viswanathan V, Uike P, Gaigaware P, Yadav S, Dhaliwal RS, Ramakrishnan S, Tullu FT, Bhargava B. India Hypertension Control Initiative-Hypertension treatment and blood pressure control in a cohort in 24 sentinel site clinics. J Clin Hypertens (Greenwich). 2021 Apr;23(4):720-729. doi: 10.1111/jch.14141. Epub 2020 Dec 23.
citation: Bloom DE, Cafiero E, Jané-Llopis E, Abrahams-Gessel S, Bloom LR, Fathima S, Feigl AB, Gaziano T, Hamandi A, Mowafi M, O'Farrell D. The global economic burden of noncommunicable diseases. Program on the Global Demography of Aging; 2012 Jan.
citation: World Health Organization. National STEPS survey for non-communicable diseases risk factors in Bangladesh 2018.
citation: World Health Organization. HEARTS Technical package for cardiovascular disease management in primary health care. Geneva: WHO; 2016.