HEARTS Package Evaluation Trial in Bangladesh

July 13, 2023 updated by: National Heart Foundation of Bangladesh

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3935

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Bangladesh
      • Habiganj, Bangladesh
        • Baniachang Upazila Health Complex
      • Habiganj, Bangladesh
        • Madhabpur Upazila Health Complex
      • Jamalpur, 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
      • Kishoreganj, Bangladesh
        • Karimganj Upazila Health Complex
      • Kishoreganj, Bangladesh
        • Katiadi Upazila Health Complex
      • Kishoreganj, Bangladesh
        • Tarail Upazila Health Complex
      • Sunamganj, Bangladesh
        • Biswamvarpur Upazila Health Complex
      • Sunamganj, Bangladesh
        • Doarabajar Upazila Health Complex
      • Sylhet, Bangladesh
        • Gowainghat Upazila Health Complex
    • Dhaka
      • Jamalpur, Dhaka, Bangladesh, 1207
        • Madarganj Upazila Health Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Arm
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
Participants of this arm will receive all the components of WHO HEARTS technical package components as an intervention.
Other: WHO HEARTS technical package

Components of WHO HEARTS technical package are

  1. Universal BP screening via A&D arm-in BP device.
  2. Training of Medical Officers and Nurses on BP measurement using standard techniques.
  3. Training of the nurses on screening, registration data collection via the Simple mobile smart-phone digital clinical hypertension information application.
  4. Use of a drug and dose specific hypertension treatment protocol.
  5. Standardized inventory and procurement practice to ensure a reliable supply of protocol medications.
  6. Training and support for team-based model of hypertension care delivery.
  7. Access to the Simple data dashboard for program monitoring.
  8. Standardized procedure for patient follow-up.
  9. Community-based prescription refilling.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Six months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Six months
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
Six months
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
Six months
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
Six months
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
Six months
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
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Heart Foundation of Bangladesh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
Resolve to Save Lives
National Heart Foundation Hospital and Research Institute, Bangladesh
Non-communicable Disease Control Programme, Directorate General of Health Services, Bangladesh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sohel R Choudhury, PhD, National Heart Foundation Hospital and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N.H.F.H.&R.I:4-14/7/AD/1074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified IPD will be shared with the other researchers.

IPD Sharing Time Frame

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 Sharing Access Criteria

IPD will be shared will the collaborator researchers who will participate in the data analysis and report writing.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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