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

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ClinicalTrials.gov Identifier: NCT02341651
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : November 23, 2015
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Aga Khan University
University of Kelaniya
Information provided by (Responsible Party):
Professor Tazeen Jafar, Duke-NUS Graduate Medical School

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Multicomponent intervention Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official 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)
Study Start Date : August 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multicomponent "combination"
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
Other: Multicomponent intervention
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

No Intervention: Usual Care
No active intervention



Primary Outcome Measures :
  1. retention rate [ Time Frame: 3 months ]
    proportion of hypertensive individuals followed up at 3 months in 3 countries


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341651


Locations
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Bangladesh
Centre for Control of Chronic Diseases icddr,b
Dhaka, Mohakhali, Bangladesh, 1212
Pakistan
Aga Khan University Hospital
Karachi, Pakistan, 74800
Sri Lanka
University of Kelaniya
Ragama, Sri Lanka
Sponsors and Collaborators
Duke-NUS Graduate Medical School
International Centre for Diarrhoeal Disease Research, Bangladesh
Aga Khan University
University of Kelaniya
Investigators
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Principal Investigator: Tazeen H Jafar, MD, MPH Duke-NUS, Singapore
Principal Investigator: Dewan Alam Centre for Control of Chronic Diseases icddr,b, Bangladesh
Principal Investigator: Imtiaz Jehan Aga Khan University
Principal Investigator: Asita de Silva University of Kelaniya, Sri Lanka
Principal Investigator: Shah Ebrahim London School of Hygiene and Tropical Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Tazeen Jafar, Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT02341651     History of Changes
Other Study ID Numbers: MR/L004224/1
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: November 23, 2015
Last Verified: November 2015
Keywords provided by Professor Tazeen Jafar, Duke-NUS Graduate Medical School:
High blood pressure
Cardiovascular diseases
Antihypertensive agents
Pharmacological treatment
Non-pharmacological treatment
Community health care workers
Treatment algorithm
Public and private healthcare providers
Strategy
Referral loops
Intervention
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases