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

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Multicomponent intervention
Sponsored by
Duke-NUS Graduate Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring 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

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Control of Chronic Diseases icddr,b
  • Aga Khan University Hospital
  • University of Kelaniya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multicomponent "combination"

Usual Care

Arm Description

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 active intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fidelity measure- Proportion of providers trained
proportion of targeted providers trained in 3 countries
Fidelity measure- home health education sessions delivered
Proportion of planned home health education sessions delivered in 3 countries
fidelity measure 3- physician management checklist collected
proportion of expected physician management checklist collected
Baseline to follow-up change in systolic blood pressure level
within clusters intra-class correlation (95% CI) pre- to post- intervention change in systolic

Full Information

First Posted
December 28, 2014
Last Updated
November 19, 2015
Sponsor
Duke-NUS Graduate Medical School
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, Aga Khan University, University of Kelaniya
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1. Study Identification

Unique Protocol Identification Number
NCT02341651
Brief Title
Control of Blood Pressure and Risk Attenuation-rural Bangladesh, Pakistan, Sri Lanka, Feasibility Study
Acronym
COBRA-BPS
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke-NUS Graduate Medical School
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, Aga Khan University, University of Kelaniya

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
453 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multicomponent "combination"
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No active intervention
Intervention Type
Other
Intervention Name(s)
Multicomponent intervention
Intervention Description
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 Outcome Measure Information:
Title
retention rate
Description
proportion of hypertensive individuals followed up at 3 months in 3 countries
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Fidelity measure- Proportion of providers trained
Description
proportion of targeted providers trained in 3 countries
Time Frame
3 months
Title
Fidelity measure- home health education sessions delivered
Description
Proportion of planned home health education sessions delivered in 3 countries
Time Frame
3 months
Title
fidelity measure 3- physician management checklist collected
Description
proportion of expected physician management checklist collected
Time Frame
3 months
Title
Baseline to follow-up change in systolic blood pressure level
Description
within clusters intra-class correlation (95% CI) pre- to post- intervention change in systolic
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tazeen H Jafar, MD, MPH
Organizational Affiliation
Duke-NUS, Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dewan Alam
Organizational Affiliation
Centre for Control of Chronic Diseases icddr,b, Bangladesh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Imtiaz Jehan
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asita de Silva
Organizational Affiliation
University of Kelaniya, Sri Lanka
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shah Ebrahim
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Control of Chronic Diseases icddr,b
City
Dhaka
State/Province
Mohakhali
ZIP/Postal Code
1212
Country
Bangladesh
Facility Name
Aga Khan University Hospital
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
University of Kelaniya
City
Ragama
Country
Sri Lanka

12. IPD Sharing Statement

Citations:
PubMed Identifier
27488552
Citation
Jafar TH, Silva Ad, Naheed A, Jehan I, Liang F, Assam PN, Legido-Quigley H, Finkelstein EA, Ebrahim S, Wickremasinghe R, Alam D, Khan AH; COBRA-BPS Study Group. Control of blood pressure and risk attenuation: a public health intervention in rural Bangladesh, Pakistan, and Sri Lanka: feasibility trial results. J Hypertens. 2016 Sep;34(9):1872-81. doi: 10.1097/HJH.0000000000001014.
Results Reference
derived

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

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