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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Telemedicine-based WHO HEARTS package

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sohel R Choudhury, PhD; Phone Number: 258 +880258054708; Email: choudhurys@nhf.org.bd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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-; Community- and team-based model of hypertension care delivery; Opportunistic hypertension screening at Community Clinic (CC) by Community Health Care Provider (CHCP); 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; Use of Simple App to document BP readings and medications/dosage and to monitor hypertension care delivery at the CC through utilities including dashboards; Establishment of telemedicine service between CC and Upazila Health Complex (UHC); Community-based, multi-month prescription refills from CC; Training of clinic and research staff on BP measurement following standard techniques; Site monitoring and mentorship to ensure screening and patient enrollment/registration; Use of text messages to promote follow-up visits and medication adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment proportion	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	6 months from enrollment
Short-term, intermediate, and 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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure control	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)	3, 6, 12, and 18 months from enrollment

Collaborators and Investigators

• Sponsor: National Heart Foundation of Bangladesh
• Collaborators: Johns Hopkins University; Non-communicable Disease Control Programme, Directorate General of Health Services, Bangladesh; National Heart Foundation Hospital and Research Institute; Community Based Health Care, Directorate General of Health Services, Bangladesh
• Investigators: Principal Investigator: Sohel R Choudhury, PhD, National Heart Foundation Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: BMRC/NREC/2022-2025/102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No