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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
2,550
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.
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
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
Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Time frame: 24 months
Daytime SBP/DBP
secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Time frame: 24 months
Night time SBP/DBP
Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Time frame: 24 months
Dipping Pattern
Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Time frame: 24 months
24 hour BP variability
Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Time frame: 24 months
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
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