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

Study Overview
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Brief Summary
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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.

Official Title
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Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan and Sri Lanka (COBRA-BPS)

Conditions
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Hypertension

Intervention / Treatment
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* Other: multi-component interventions


Participation Criteria
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Eligibility Criteria
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Main study: Inclusion Criteria: Age≥ 40 years Residing in the selected clusters Hypertension defined either as: 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 maintained on anti-hypertensive medications Informed consent Exclusion Criteria: Permanently bed-ridden individuals too ill to commute to the clinic Pregnancy, or individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases) 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 -

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care<br>Usual care comprises existing services for hypertension control in the community without any additional training | |
| Experimental: multi-component interventions<br>: 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. | Other: multi-component interventions<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure reading:Blood Pressure(BP) controlled to target (Systolic BP <140 mm Hg and Diastolic BP <90 mm |  | 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 |  | 24 months | 
| Questionnaire and EQ-5D-5L:Incremental cost per quality-adjusted life-year (QALY) gained from baseline to end of follow-up |  | 24 months | 
| Morisky Medication Adherence Scale(MMAS):Change in antihypertensive medication adherence (Morisky score) |  | 24 months | 
| Height and weight measurements:change in body mass index ( BMI) |  | 24 months | 
| questionnaire:change dietary salt intake (urinary excretion) |  | 24 months | 
| Questionnaire:change in prevalence of current smokers |  | 24 months | 
| Questionnaire:incident diabetes |  | 24 months | 
| Lipid panel: change in serum lipid levels |  | 24 months | 
| questionnaire: change in INTERHEART cardiovascular disease (CVD) risk score |  | 24 months | 
| Questionnaire:incidence of adverse outcomes (medication side effects, sick days absenteeism, low QALY between randomized groups). |  | 24 months | 
| Questionnaire and serum creatinine:Change in estimated glomerular filtration rate (eGFR) |  | 24 months | 
| Urine albumin:Change in urine albumin |  | 24 months | 
| 24 hours mean diastolic BP | Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline | 24 months | 
| Daytime SBP/DBP | secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline | 24 months | 
| Night time SBP/DBP | Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline | 24 months | 
| Dipping Pattern | Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline | 24 months | 
| 24 hour BP variability | Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline | 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 |  | 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 |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood pressure monitoring, high blood pressure, cardiovascular disease, Antihypertensive agents, Non-pharmacological treatment, community health care workers, cost-effectiveness