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NCT Number: NCT02341651

Control of Blood Pressure and Risk Attenuation-rural Bangladesh, Pakistan, Sri Lanka, Feasibility Study

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. A trial to investigate integrated primary care strategies to control hypertension is planned. Packaged interventions for the planned full-scale study are varying combinations of 1) home health education (HHE) by trained community health workers (CHW), 2) trained government primary health centre mid-level providers (MLP) led care and 3) trained private practitioners. The goal of the full-scale study is to test which combination of the above interventions is the most effective in lowering blood pressure among adults with hypertension in rural communities. In addition, the full-scale study aims to quantify the incremental cost- effectiveness of each approach in terms of cost per projected cardiovascular disease (CVD) disability adjusted life-years (DALYs) averted.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Initiative for Non-Communicable Diseases icddr,b, Dhaka, Mohakhali, Bangladesh

Loading trial locations.

About this study

The rationale for conducting the feasibility study in 3 proposed South Asian countries is strong. The South Asian countries are in a unique stage of epidemiological transition with a double burden of communicable and NCDs, the latter increasing rapidly. (2) These countries also share cultural habits and social structure with an extended family system, and have largely similar population characteristics and health seeking behaviours. (10)Moreover, the rural health system in all South Asian countries relies on cadres community health workers. At the same time there are some differences. Bangladesh and Pakistan have a high proportion of people living in extreme poverty (purchasing power parity <US $1.25/day, 49.6% and 22.6%, respectively) compared to Sri Lanka (14%) which has relatively better development indicators in terms of life expectancy and literacy rates (World Bank 2010). However age-standardized death rates from non-communicable diseases (NCDs) are uniformly high in all 3 countries. The feasibility will allow direct comparison of some of these population (individual) and health systems characteristics among countries relevant for hypertension care. Thus, data from the feasibility will inform the future design of the trial.

In order to optimize the trial design of the full study, a mixed-methods feasibility study with quasi-experimental pre- and post- evaluation of "triple approach" with all 3 components of intervention, survey of pharmacies, and focus group discussions and individual in-depth interviews to better inform the strategies for the full-scale trial in rural settings in Bangladesh, Pakistan, and Sri Lanka.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 2 readings from 2 separate days
  • maintained on anti-hypertensive medications
  • Informed consent

Exclusion criteria

  • Bed-ridden individuals too ill to commute to the clinic
  • Individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases)
  • Individuals that are mentally compromised and unable to give informed consent

Treatment and study plan

Multicomponent intervention

Other

Multicomponent intervention is a combination of the following 1) community health worker (CHW)- led blood pressure (BP) screening and referral to provider, plus 2) home health education (HHE) adapted to the local diet by trained CHW plus 3) trained primary health center mid-level providers (MLP) and physicians using evidence-based treatment algorithm of BP lowering in all and lipid lowering for high risk, plus 4) process-based incentives

Primary outcomes

  1. retention rate

    Time frame: 3 months

    proportion of hypertensive individuals followed up at 3 months in 3 countries

Secondary outcomes

  1. Fidelity measure- Proportion of providers trained

    Time frame: 3 months

    proportion of targeted providers trained in 3 countries

  2. Fidelity measure- home health education sessions delivered

    Time frame: 3 months

    Proportion of planned home health education sessions delivered in 3 countries

  3. fidelity measure 3- physician management checklist collected

    Time frame: 3 months

    proportion of expected physician management checklist collected

  4. Baseline to follow-up change in systolic blood pressure level

    Time frame: 3 months

    within clusters intra-class correlation (95% CI) pre- to post- intervention change in systolic

Sponsors and collaborators

Lead sponsor

Duke-NUS Graduate Medical School

Other

Collaborators

  • Aga Khan University
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • University of Kelaniya

Registry information

Official study title

Feasibility Study for a Cluster Randomized Trial on Integrated Primary Care Strategies to Reduce High Blood Pressure (Control of Blood Pressure and Risk Attenuation-rural Bangladesh, Pakistan, Sri Lanka, Feasibility Study)

Acronym: COBRA-BPS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2015
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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