Please use this identifier to cite or link to this item: https://doi.org/10.1186/s13063-017-2018-0
Title: Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: Study protocol for a cluster randomized controlled trial
Authors: Jafar, T.H 
Jehan, I
de Silva, H.A
Naheed, A
Gandhi, M 
Assam, P
Finkelstein, E.A 
Quigley, H.L 
Bilger, M 
Khan, A.H
Clemens, J.D
Ebrahim, S
Turner, E.L
Kasturiratne, A
for COBRA-BPS Study Group and Anuradhani Kasturiratne
Keywords: adult
antihypertensive therapy
Article
Bangladesh
blood pressure monitoring
blood pressure regulation
checklist
clinical education
clinical protocol
cluster analysis
community care
comparative effectiveness
controlled study
cost effectiveness analysis
diastolic blood pressure
disability adjusted life year
emergency health service
follow up
general practitioner
health auxiliary
health care financing
health education
home care
human
hypertension
intermethod comparison
lowest income group
major clinical study
multicomponent intervention
Pakistan
patient referral
qualitative research
quality of life
randomized controlled trial
rural area
rural population
semi structured interview
Sri Lanka
systolic blood pressure
therapy
treatment outcome
attitude to health
blood pressure
blood pressure measurement
clinical trial
cost benefit analysis
disability
drug effects
economics
female
health behavior
health care cost
hypertension
male
methodology
multicenter study
multimodality cancer therapy
pathophysiology
patient education
patient referral
risk reduction
rural health care
time factor
antihypertensive agent
Adult
Antihypertensive Agents
Bangladesh
Blood Pressure
Blood Pressure Determination
Checklist
Combined Modality Therapy
Cost-Benefit Analysis
Disability Evaluation
Female
Health Behavior
Health Care Costs
Health Knowledge, Attitudes, Practice
Humans
Hypertension
Male
Pakistan
Patient Education as Topic
Referral and Consultation
Research Design
Risk Reduction Behavior
Rural Health Services
Sri Lanka
Time Factors
Treatment Outcome
Issue Date: 2017
Citation: Jafar, T.H, Jehan, I, de Silva, H.A, Naheed, A, Gandhi, M, Assam, P, Finkelstein, E.A, Quigley, H.L, Bilger, M, Khan, A.H, Clemens, J.D, Ebrahim, S, Turner, E.L, Kasturiratne, A, for COBRA-BPS Study Group and Anuradhani Kasturiratne (2017). Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: Study protocol for a cluster randomized controlled trial. Trials 18 (1) : 272. ScholarBank@NUS Repository. https://doi.org/10.1186/s13063-017-2018-0
Abstract: Background: High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension continues to be a significant public health issue with sub-optimal BP control rates. The goal of the trial is to compare a multicomponent intervention (MCI) to usual care to evaluate the effectiveness and cost-effectiveness of the MCI for lowering BP among adults with hypertension in rural communities in Bangladesh, Pakistan and Sri Lanka. Methods/design: This study is a stratified, cluster randomized controlled trial with a qualitative component for evaluation of processes and stakeholder feedback. The MCI has five components: (1) home health education by government community health workers (CHWs), (2) BP monitoring and stepped-up referral to a trained general practitioner using a checklist, (3) training public and private providers in management of hypertension and using a checklist, (4) designating hypertension triage counter and hypertension care coordinators in government clinics and (5) a financing model to compensate for additional health services and provide subsidies to low income individuals with poorly controlled hypertension. Usual care will comprise existing services in the community without any additional training. The trial will be conducted on 2550 individuals aged ?40 years with hypertension (with systolic BP ?140 mm Hg or diastolic BP ?90 mm Hg, based on the mean of the last two of three measurements from two separate days, or on antihypertensive therapy) in 30 rural communities in Bangladesh, Pakistan and Sri Lanka. The primary outcome is change in systolic BP from baseline to follow-up at 24 months post-randomization. The incremental cost of MCI per CVD disability-adjusted life years averted will be computed. Stakeholders including policy makers, provincial- and district-level coordinators of relevant programmes, physicians, CHWs, key community leaders, hypertensive individuals and family members in the identified clusters will be interviewed. Discussion: The study will provide evidence of the effectiveness and cost-effectiveness of MCI strategies for BP control compared to usual care in the rural public health infrastructure in South Asian countries. If shown to be successful, MCI may be a long-term sustainable strategy for tackling the rising rates of CVD in low resourced countries. Trial registration: ClinicalTrials.gov, NCT02657746. Registered on 14 January 2016. © 2017 The Author(s).
Source Title: Trials
URI: https://scholarbank.nus.edu.sg/handle/10635/173785
ISSN: 17456215
DOI: 10.1186/s13063-017-2018-0
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