HEARTS Package Evaluation Trial in Bangladesh

National Heart Foundation of Bangladesh

Status: Completed

Conditions: Hypertension

Treatments: Other: WHO HEARTS technical package

Study type: Interventional

Funder types: Other

Identifiers

NCT04992039

N.H.F.H.&R.I:4-14/7/AD/1074

Details and patient eligibility

About

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.

Enrollment: 3,935 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,935 participants in 2 patient groups

Control Arm

No Intervention group

Description:

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 group

Description:

Participants of this arm will receive all the components of WHO HEARTS technical package components as an intervention.

Treatment:

Other: WHO HEARTS technical package