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Clinical Trials/NCT05954884
NCT05954884
Not yet recruiting
Not Applicable

Community-based HEARTS Intervention (Pilot)

National Heart Foundation of Bangladesh0 sites400 target enrollmentAugust 1, 2023
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
National Heart Foundation of Bangladesh
Enrollment
400
Primary Endpoint
Enrollment proportion
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
March 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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 Outcomes

  • Blood pressure control(3, 6, 12, and 18 months from enrollment)

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