Clinical trial NCT05954884: Community-based HEARTS Intervention (Pilot)
Official title: Community-based HEARTS Intervention (Pilot)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: National Heart Foundation of Bangladesh
Sponsor class: OTHER
Collaborators: name: National Heart Foundation Hospital and Research Institute
name: Johns Hopkins University
name: Non-communicable Disease Control Programme, Directorate General of Health Services, Bangladesh
name: Community Based Health Care, Directorate General of Health Services, Bangladesh
First posted: 2023-07-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Enrollment proportion
timeFrame: 6 months from enrollment
measure: Short-term, intermediate, and long-term retention in care
timeFrame: 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 outcomes:
measure: Blood pressure control
timeFrame: 3, 6, 12, and 18 months from enrollment
Other outcomes:
Locations:
Study officials:
affiliation: National Heart Foundation Hospital and Research Institute
name: Sohel R Choudhury, PhD
role: PRINCIPAL_INVESTIGATOR
References: