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Completed

NCT Number: NCT04992039

HEARTS Package Evaluation Trial in Bangladesh

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Madarganj Upazila Health Complex, Jāmālpur, Dhaka Division, Bangladesh

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WHO HEARTS technical package

Other

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.

Primary outcomes

  1. Difference in differences of systolic blood pressure (SBP)

    Time frame: Six months

    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)

Secondary outcomes

  1. Difference in differences of diastolic blood pressure (DBP)

    Time frame: Six months

    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)

  2. Difference in differences of rate of hypertension control.

    Time frame: Six months

    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

  3. Rate of loss to follow-up.

    Time frame: Six months

    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

  4. Difference in differences of rate of hypertension control (Measured in the clinic)

    Time frame: Six months

    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

  5. Rate of loss to follow up

    Time frame: Six months

    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

  6. Difference in time to BP control

    Time frame: Six months

    difference in time-to-control between arms based on follow-up in-clinic BP and assessed using the log-rank test

Sponsors and collaborators

Lead sponsor

National Heart Foundation of Bangladesh

Other

Collaborators

  • Directorate General of Health Services, Bangladesh
  • Johns Hopkins University
  • National Heart Foundation Hospital and Research Institute, Bangladesh
  • Resolve to Save Lives

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 5, 2021
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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