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HypertensionNCT04992039

HEARTS Package Evaluation Trial in Bangladesh

A study testing WHO HEARTS technical package in people with Hypertension, run by National Heart Foundation of Bangladesh at 14 sites in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
WHO HEARTS technical package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,935 participants
Where
14 sitesBangladesh
Study dates
9 Oct 2021to 12 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

14 sites in 1 country.

14 sites in 1 country

Bangladesh14 sites

  • Baniachang Upazila Health Complex

    Habiganj

  • Madhabpur Upazila Health Complex

    Habiganj

  • Bakhshiganj Upazila Health Complex

    Jamalpur

  • Dewanganj Upazila Health Complex

    Jamalpur

  • Islampur Upazila Health Complex

    Jamalpur

  • Melandaha Upazila Health Complex

    Jamalpur

  • Sarishabari Upazila Health Complex

    Jamalpur

  • Madarganj Upazila Health Complex

    Jāmālpur, Dhaka Division, 1207

  • Karimganj Upazila Health Complex

    Kishoreganj

  • Katiadi Upazila Health Complex

    Kishoreganj

  • Tarail Upazila Health Complex

    Kishoreganj

  • Biswamvarpur Upazila Health Complex

    Sunāmganj

  • Doarabajar Upazila Health Complex

    Sunāmganj

  • Gowainghat Upazila Health Complex

    Sylhet

Other trials in Bangladesh

About this study

Official title: 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.

Conditions
Hypertension
Being tested
WHO HEARTS technical package
Keywords
High Blood Pressure, Hypertension, Hypertension Control Program, World Health Organization HEARTS Technical Package
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WHO HEARTS technical packageOther

    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.
Study groups in NCT04992039
Study groupRoleWhat they receive
Control ArmNo interventionParticipants 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 ArmExperimentalParticipants of this arm will receive all the components of WHO HEARTS technical package components as an intervention.
Receives: Other: WHO HEARTS technical package

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Six months

Secondary outcomes (6)

  1. 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)

    Measured: Six months

  2. 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

    Measured: Six months

  3. 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

    Measured: Six months

  4. 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

    Measured: Six months

  5. 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

    Measured: Six months

  6. 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

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start9 Oct 2021
  3. Primary completion31 Dec 2021
  4. Study completion12 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant
Enrolment
3,935 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04992039
Sponsor's protocol ID
N.H.F.H.&R.I:4-14/7/AD/1074
Status last verified
Jul 2023
First submitted
28 Jul 2021
Last updated
14 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified IPD will be shared with the other researchers.

Publications

  • 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.

    PubMed 27502908

  • 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.

    PubMed 33369074

  • 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.

  • World Health Organization. National STEPS survey for non-communicable diseases risk factors in Bangladesh 2018.

  • World Health Organization. HEARTS Technical package for cardiovascular disease management in primary health care. Geneva: WHO; 2016.

  • 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.

    PubMed 39019496

Questions about this trial

What is this clinical trial studying?

A study testing WHO HEARTS technical package in people with Hypertension, run by National Heart Foundation of Bangladesh at 14 sites in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in differences of systolic blood pressure (SBP) (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04992039, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.

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