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Community-based HEARTS Intervention (Pilot) (CB-HEARTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05954884
Recruitment Status : Not yet recruiting
First Posted : July 20, 2023
Last Update Posted : July 20, 2023
Sponsor:
Collaborators:
National Heart Foundation Hospital and Research Institute
Johns Hopkins University
Non-communicable Disease Control Programme, Directorate General of Health Services, Bangladesh
Community Based Health Care, Directorate General of Health Services, Bangladesh
Information provided by (Responsible Party):
National Heart Foundation of Bangladesh

Study Description
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Brief Summary:

The goal of this pilot study is to assess the feasibility of health system change intervention with a focus on recruitment of patients with hypertension, initiation of antihypertensive medication, and retention of patients in care at the Community Clinics (CC) with a goal of finalizing the key features of a team- and community-based intervention in rural Bangladesh.

Patients with uncomplicated hypertension will be enrolled, their medical treatment will be provided from CC by a Community Health Care Provider (CHCP) according to the telemedicine-based instruction of Medical Officer from Upazila Health Complex (UHC) with provision of referral to UHC for an in-person evaluation. Participants will be followed up periodically and their medicine will be refilled accordingly.


Condition or disease Intervention/treatment Phase
Hypertension Other: Telemedicine-based WHO HEARTS package Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Community-based HEARTS Intervention (Pilot)
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
This is a single-arm pilot study and all participants will receive the intervention. Participants will be diagnosed and treated for hypertension at Community Clinic (CC) by a Community Health Care Provider (CHCP) under telemedicine supervision from a Medical Officer at the Upazila Health Complex (UHC).
 Other: Telemedicine-based WHO HEARTS package

Interventions in this study will include-

  1. Community- and team-based model of hypertension care delivery
  2. Opportunistic hypertension screening at Community Clinic (CC) by Community Health Care Provider (CHCP)
  3. Use of a hypertension treatment protocol with amlodipine and losartan and standardized approach to measuring and monitoring BP, retaining participants in care, and promoting adherence
  4. Use of Simple App to document BP readings and medications/dosage and to monitor hypertension care delivery at the CC through utilities including dashboards
  5. Establishment of telemedicine service between CC and Upazila Health Complex (UHC)
  6. Community-based, multi-month prescription refills from CC
  7. Training of clinic and research staff on BP measurement following standard techniques
  8. Site monitoring and mentorship to ensure screening and patient enrollment/registration
  9. Use of text messages to promote follow-up visits and medication adherence


Outcome Measures
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Primary Outcome Measures :
  1. Enrollment proportion [ Time Frame: 6 months from enrollment ]
    The proportion of eligible individuals with raised BP identified at the Community Clinic (CC) who were enrolled, defined as those started on meds within 6 months of diagnosis

  2. Short-term, intermediate, and long-term retention in care [ Time Frame: 3 months from enrollment for short-term retention in care, 6 to 12 months for intermediate retention in care, and 12 to 18 months for long-term retention in care ]
    The proportion of enrolled individuals with raised BP who had a follow-up visit within 3 months of enrollment (short-term retention in care), between 6 and 12 months (intermediate retention in care), and between 12 and 18 months (long-term retention in care)


Secondary Outcome Measures :
  1. Blood pressure control [ Time Frame: 3, 6, 12, and 18 months from enrollment ]
    The proportion of those enrolled at the Community Clinic with BP controlled (<140/90 mmHg) at 3, 6, 12, and 18 months (denominator includes patients who do not return for follow up BP measurement)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients residing in the catchment area of the selected 4 Community Clinics under selected 2 Upazila Health Complexes (UHCs)
  • Aged 18 years and older
  • Raised BP during screening [Systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg (based on an average of minimum two measurements)]
  • Not currently taking antihypertensive medications
  • Eligible for the HEARTS technical package, defined as not being treated for an acute illness or medical emergency and not having a terminal illness

Exclusion Criteria:

  • Patients with cardiovascular diseases, chronic kidney diseases (as evident by previous laboratory report of serum creatinine or urinary protein more than ++ on dipstick test prior to the enrollment), diabetes, or BP >180/110 mmHg (based on the mean of last two BP measurements) at screening or after 14 days of recommended lifestyle modification will be excluded and referred directly to UHC for further management
  • Pregnancy or intent to become pregnant
  • Patients who otherwise meet inclusion criteria but decline to participate in the hypertension program evaluation or do not provide written informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05954884


Contacts
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Contact: Sohel R Choudhury, PhD +880258054708 ext 258 choudhurys@nhf.org.bd

Sponsors and Collaborators
National Heart Foundation of Bangladesh
National Heart Foundation Hospital and Research Institute
Johns Hopkins University
Non-communicable Disease Control Programme, Directorate General of Health Services, Bangladesh
Community Based Health Care, Directorate General of Health Services, Bangladesh
Investigators
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Principal Investigator: Sohel R Choudhury, PhD National Heart Foundation Hospital and Research Institute
More Information
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Responsible Party: National Heart Foundation of Bangladesh
ClinicalTrials.gov Identifier: NCT05954884    
Other Study ID Numbers: BMRC/NREC/2022-2025/102
First Posted: July 20, 2023    Key Record Dates
Last Update Posted: July 20, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases