Community-based HEARTS Intervention (Pilot)

Hypertension Clinical Trial

— CB-HEARTS  

Official title:

Community-based HEARTS Intervention (Pilot)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05954884
• Other study ID #: BMRC/NREC/2022-2025/102
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: July 2023
• Source: National Heart Foundation of Bangladesh
• Contact: Sohel R Choudhury, PhD
• Phone: +880258054708
• Email: choudhurys[@]nhf.org.bd
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
National Heart Foundation of Bangladesh	Community Based Health Care, Directorate General of Health Services, Bangladesh, Johns Hopkins University, National Heart Foundation Hospital and Research Institute, Non-communicable Disease Control Programme, Directorate General of Health Services, Bangladesh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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