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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02657746
Acronym
COBRA-BPS
Enrollment
2550
Registered
2016-01-18
Start date
2016-05-01
Completion date
2020-03-31
Last updated
2019-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

blood pressure monitoring, high blood pressure, cardiovascular disease, Antihypertensive agents, Non-pharmacological treatment, community health care workers, cost-effectiveness

Brief summary

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.

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.

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
Aga Khan University
CollaboratorOTHER
University of Kelaniya
CollaboratorOTHER
Duke-NUS Graduate Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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 \-

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
Questionnaire:Composite outcome of death (all cause), or hospital admission due to coronary heart disease (CHD), heart failure, or stroke24 months
Questionnaire and EQ-5D-5L:Incremental cost per quality-adjusted life-year (QALY) gained from baseline to end of follow-up24 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 smokers24 months
Questionnaire:incident diabetes24 months
Lipid panel: change in serum lipid levels24 months
questionnaire: change in INTERHEART cardiovascular disease (CVD) risk score24 months
Blood pressure reading:Blood Pressure(BP) controlled to target (Systolic BP <140 mm Hg and Diastolic BP <90 mmat 6-month intervals over 24 months
Questionnaire and serum creatinine:Change in estimated glomerular filtration rate (eGFR)24 months
Urine albumin:Change in urine albumin24 months
24 hours mean diastolic BP24 monthsSecondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Daytime SBP/DBP24 monthssecondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Night time SBP/DBP24 monthsSecondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Dipping Pattern24 monthsSecondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
24 hour BP variability24 monthsSecondary 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) avertedinformation 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) averted24 months
Questionnaire:incidence of adverse outcomes (medication side effects, sick days absenteeism, low QALY between randomized groups).24 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026