Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka

Overview

Background: High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension remains to be a significant public health issue with sub-optimal rates of case finding and management. The goal of the full-scale study is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care strategies on lowering blood pressure among adults with hypertension in rural communities in Bangladesh, Pakistan, and Sri Lanka. Methods/Design: The mixed-methods, stratified cluster randomized controlled trial Intervention: The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension. Usual care: Will comprise existing services in the community without any additional training. Participants: The trial will be conducted on 2550 individuals aged 40 years or older with hypertension (systolic BP ≥ 140 mm Hg or diastolic BP≥ 90 mm Hg, or on antihypertensive therapy) in 30 rural communities of Bangladesh, Pakistan and Sri Lanka. Out of the 2550 individuals, 420 with poorly controlled BP (Systolic BP≥160 mmHg or Diastolic BP≥100 mmHg) will be selected, 14 from each community, to investigate the effect of MCI on results from ambulatory BP monitoring. Qualitative component: Stakeholders including policymakers, district managers, and community health workers, GPs, hypertensive individuals and family members in the identified clusters will be surveyed. Outcome: The primary outcome will be change in systolic BP from baseline to follow-up at 24 months post randomization. The cost effectiveness outcome is the incremental cost of MCI per unit reduction in BP over the two year time period and in terms of incremental cost per CVD DALYs averted.

Full Title of Study: “Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan and Sri Lanka (COBRA-BPS)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2019

Interventions

  • Other: multi-component interventions
    • The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension.

Arms, Groups and Cohorts

  • No Intervention: usual care
    • Usual care comprises existing services for hypertension control in the community without any additional training
  • Experimental: multi-component interventions
    • : The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension.

Clinical Trial Outcome Measures

Primary Measures

  • Blood pressure reading:change in systolic blood pressure (SBP) from baseline to follow-up at 24 months post randomization.
    • Time Frame: Blood pressure (BP) will measured at baseline and then at 6-month intervals until 24 months after randomization

Secondary Measures

  • Blood pressure reading:Blood Pressure(BP) controlled to target (Systolic BP <140 mm Hg and Diastolic BP <90 mm
    • Time Frame: at 6-month intervals over 24 months
  • Questionnaire:Composite outcome of death (all cause), or hospital admission due to coronary heart disease (CHD), heart failure, or stroke
    • Time Frame: 24 months
  • Questionnaire and EQ-5D-5L:Incremental cost per quality-adjusted life-year (QALY) gained from baseline to end of follow-up
    • Time Frame: 24 months
  • Morisky Medication Adherence Scale(MMAS):Change in antihypertensive medication adherence (Morisky score)
    • Time Frame: 24 months
  • Height and weight measurements:change in body mass index ( BMI)
    • Time Frame: 24 months
  • questionnaire:change dietary salt intake (urinary excretion)
    • Time Frame: 24 months
  • Questionnaire:change in prevalence of current smokers
    • Time Frame: 24 months
  • Questionnaire:incident diabetes
    • Time Frame: 24 months
  • Lipid panel: change in serum lipid levels
    • Time Frame: 24 months
  • questionnaire: change in INTERHEART cardiovascular disease (CVD) risk score
    • Time Frame: 24 months
  • Questionnaire:incidence of adverse outcomes (medication side effects, sick days absenteeism, low QALY between randomized groups).
    • Time Frame: 24 months
  • Questionnaire and serum creatinine:Change in estimated glomerular filtration rate (eGFR)
    • Time Frame: 24 months
  • Urine albumin:Change in urine albumin
    • Time Frame: 24 months
  • 24 hours mean diastolic BP
    • Time Frame: 24 months
    • Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
  • Daytime SBP/DBP
    • Time Frame: 24 months
    • secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
  • Night time SBP/DBP
    • Time Frame: 24 months
    • Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
  • Dipping Pattern
    • Time Frame: 24 months
    • Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
  • 24 hour BP variability
    • Time Frame: 24 months
    • Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
  • Questionnaire and EQ-5D-5L:Incremental cost per mm Hg BP reduction from baseline to end of follow-up at two years post randomization and incremental cost per projected cardiovascular disease ( CVD) disability adjusted life year (DALY) averted
    • Time Frame: information on healthcare cost will be collected at baseline and 24 months
  • incremental cost per mm Hg BP reduction from baseline to end of follow-up at 2 years post-randomization and incremental cost per projected CVD disability-adjusted life year (DALY) averted
    • Time Frame: 24 months

Participating in This Clinical Trial

Main study: Inclusion Criteria:

1. Age≥ 40 years 2. Residing in the selected clusters 3. Hypertension defined either as: 1. Persistently elevated BP (systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg) from each set of last 2 of 3 readings from 2 separate days 2. maintained on anti-hypertensive medications 4. Informed consent Exclusion Criteria:

1. Permanently bed-ridden individuals too ill to commute to the clinic 2. Pregnancy, or individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases) 3. Individuals that are mentally compromised and unable to give informed consent Sub-study: 1) fulfill all criteria of main study and, 2) Persistently elevated systolic BP >160 mm Hg or diastolic BP >100 mm Hg from each set of 2 readings from 2 separate days -

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke-NUS Graduate Medical School
  • Collaborator
    • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Provider of Information About this Clinical Study
    • Principal Investigator: Professor Tazeen Jafar, Professor – Duke-NUS Graduate Medical School
  • Overall Official(s)
    • Tazeen H Jafar, MD,MPH, Principal Investigator, Duke-NUS Medical School (Singapore)

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