HEARTS Package Evaluation Trial in Bangladesh

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Other: WHO HEARTS technical package


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>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. | |
| Experimental: Intervention Arm<br>Participants of this arm will receive all the components of WHO HEARTS technical package components as an intervention. | Other: WHO HEARTS technical package<br>* Components of WHO HEARTS technical package are Universal BP screening via A&D arm-in BP device. Training of Medical Officers and Nurses on BP measurement using standard techniques. Training of the nurses on screening, registration data collection via the Simple mobile smart-phone digital clinical hypertension information application. Use of a drug and dose specific hypertension treatment protocol. Standardized inventory and procurement practice to ensure a reliable supply of protocol medications. Training and support for team-based model of hypertension care delivery. Access to the Simple data dashboard for program monitoring. Standardized procedure for patient follow-up. Community-based prescription refilling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Blood Pressure, Hypertension, Hypertension Control Program, World Health Organization HEARTS Technical Package