Hypertension Clinical Trial
Official title:
Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan and Sri Lanka (COBRA-BPS)
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.
n/a
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