Clinical trial NCT02341651: Control of Blood Pressure and Risk Attenuation-rural Bangladesh, Pakistan, Sri Lanka, Feasibility Study
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Aga Khan University
name: University of Kelaniya
First posted: 2015-01-19
Enrollment: 453
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: retention rate
timeFrame: 3 months
Secondary outcomes:
measure: Fidelity measure- Proportion of providers trained
timeFrame: 3 months
measure: Fidelity measure- home health education sessions delivered
timeFrame: 3 months
measure: fidelity measure 3- physician management checklist collected
timeFrame: 3 months
measure: Baseline to follow-up change in systolic blood pressure level
timeFrame: 3 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Initiative for Non-Communicable Diseases icddr,b
state: Mohakhali
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
city: Ragama
country: Sri Lanka
facility: University of Kelaniya
Study officials:
affiliation: Duke-NUS, Singapore
name: Tazeen H Jafar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Initiative for Non-Communicable Diseases icddr,b, Bangladesh
name: Aliya Naheed
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Imtiaz Jehan
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kelaniya, Sri Lanka
name: Asita de Silva
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Shah Ebrahim
role: PRINCIPAL_INVESTIGATOR
References:
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.