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| Name | Class |
|---|---|
| Resolve to Save Lives | OTHER |
| National Heart Foundation Hospital and Research Institute, Bangladesh | UNKNOWN |
| Directorate General of Health Services, Bangladesh | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | Participants of this arm will not receive the total WHO HEARTS package as an intervention. These participants will be screened in the designated area for universal BP screening via A&D arm-in device. Their diagnosis will be confirmed by measuring their BP by a Medical Officer via an Omron desktop oscillometer. The Medical Officers and UHC nurses of the control sites will be trained up on BP measurement using standard techniques, patient registration, data collection, etc. | |
| Intervention Arm | Experimental | Participants of this arm will receive all the components of WHO HEARTS technical package components as an intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WHO HEARTS technical package | Other | Components of WHO HEARTS technical package are
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in differences of systolic blood pressure (SBP) | defined as between- group difference in BP change at six months (BP change at six months calculated for each group as end-line minus baseline mean systolic BP) | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in differences of diastolic blood pressure (DBP) | defined as between- group difference in BP change at six months (BP change at six months calculated for each group as end-line minus baseline mean diastolic BP) | Six months |
| Difference in differences of rate of hypertension control. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sohel R Choudhury, PhD | National Heart Foundation Hospital and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madarganj Upazila Health Complex | Jāmālpur | Dhaka Division | 1207 | Bangladesh | ||
| Baniachang Upazila Health Complex |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27502908 | Background | 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. | |
| 33369074 | Background | 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. |
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Deidentified IPD will be shared with the other researchers.
After completion of data collection, deidentified IPD will be shared with the collaborators and those will be available for them till completion of the report writeup.
IPD will be shared will the collaborator researchers who will participate in the data analysis and report writing.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Johns Hopkins University |
| OTHER |
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.
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defined (per UHC) as: NUMERATOR: Enrolled patients with controlled BP (SBP <140 and DBP <90 mmHg) measured in the community at six months/DENOMIN'ATOR: Total enrolled patients |
| Six months |
| Rate of loss to follow-up. | defined (per UHC) as - NUMERATOR: Enrolled patients with no clinic visit in the 3 months previous to the six-month follow up/DENOMINATOR: Total enrolled patients | Six months |
| Difference in differences of rate of hypertension control (Measured in the clinic) | defined (per UHC) as: NUMERATOR: Enrolled patients with controlled BP (SBP <140 and DBP <90 mmHg) at the most recent clinical visit within the 3 months previous to the six-month follow up/DENOMINATOR: Total enrolled patients | Six months |
| Rate of loss to follow up | defined (per UHC) as: NUMERATOR: Enrolled patients with no clinic visit in the 3 months previous to the six-month follow up/DENOMINATOR: Total enrolled patients | Six months |
| Difference in time to BP control | difference in time-to-control between arms based on follow-up in-clinic BP and assessed using the log-rank test | Six months |
| Habiganj |
| Bangladesh |
| Madhabpur Upazila Health Complex | Habiganj | Bangladesh |
| Bakhshiganj Upazila Health Complex | Jamalpur | Bangladesh |
| Dewanganj Upazila Health Complex | Jamalpur | Bangladesh |
| Islampur Upazila Health Complex | Jamalpur | Bangladesh |
| Melandaha Upazila Health Complex | Jamalpur | Bangladesh |
| Sarishabari Upazila Health Complex | Jamalpur | Bangladesh |
| Karimganj Upazila Health Complex | Kishoreganj | Bangladesh |
| Katiadi Upazila Health Complex | Kishoreganj | Bangladesh |
| Tarail Upazila Health Complex | Kishoreganj | Bangladesh |
| Biswamvarpur Upazila Health Complex | Sunāmganj | Bangladesh |
| Doarabajar Upazila Health Complex | Sunāmganj | Bangladesh |
| Gowainghat Upazila Health Complex | Sylhet | Bangladesh |
| Background | 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. |
| Background | World Health Organization. National STEPS survey for non-communicable diseases risk factors in Bangladesh 2018. |
| Background | World Health Organization. HEARTS Technical package for cardiovascular disease management in primary health care. Geneva: WHO; 2016. |
| 39019496 | Derived | Abrar A, Hu X, Akhtar J, Jubayer S, Noor Nabi Sayem M, Sultana S, Al Mamun MA, Bhuiyan MR, Malik F, Amin MR, Alim A, Gupta R, Zhao D, Farrell M, Banigbe B, Matsushita K, Burka D, Appel L, Moran AE, Choudhury SR. Evaluation of the World Health Organization-HEARTS hypertension control package in Bangladesh: a quasi-experimental trial. Heart. 2024 Aug 14;110(17):1090-1098. doi: 10.1136/heartjnl-2024-324253. |