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Title: Statistical analysis plan for the control of blood pressure and risk attenuation-rural Bangladesh, Pakistan, Sri Lanka (COBRA-BPS) trial: A cluster randomized trial for a multicomponent intervention versus usual care in hypertensive patients
Authors: Gandhi, M 
Assam, P.N
Turner, E.L
Morisky, D.E
Chan, E 
Jafar, T.H 
Keywords: antihypertensive agent
hydroxymethylglutaryl coenzyme A reductase inhibitor
antihypertensive agent
hydroxymethylglutaryl coenzyme A reductase inhibitor
anthropometric parameters
blood pressure
blood pressure measurement
body mass
clinical protocol
cluster analysis
controlled study
diabetes mellitus
diastolic blood pressure
dietary intake
follow up
health education
home care
hypertensive patient
intention to treat analysis
intervention study
major clinical study
multicenter study
patient care
patient compliance
patient referral
patient safety
physical activity
randomized controlled trial
rural population
sample size
sensitivity analysis
Sri Lanka
statistical analysis
systolic blood pressure
waist circumference
blood pressure
drug effect
healthy diet
healthy lifestyle
medication compliance
multicenter study (topic)
multimodality cancer therapy
patient-reported outcome
randomized controlled trial (topic)
risk reduction
rural health care
smoking cessation
statistical model
statistics and numerical data
time factor
treatment outcome
Antihypertensive Agents
Blood Pressure
Combined Modality Therapy
Data Interpretation, Statistical
Healthy Diet
Healthy Lifestyle
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Medication Adherence
Models, Statistical
Multicenter Studies as Topic
Patient Reported Outcome Measures
Randomized Controlled Trials as Topic
Risk Reduction Behavior
Rural Health Services
Smoking Cessation
Sri Lanka
Time Factors
Treatment Outcome
Issue Date: 2018
Citation: Gandhi, M, Assam, P.N, Turner, E.L, Morisky, D.E, Chan, E, Jafar, T.H (2018). Statistical analysis plan for the control of blood pressure and risk attenuation-rural Bangladesh, Pakistan, Sri Lanka (COBRA-BPS) trial: A cluster randomized trial for a multicomponent intervention versus usual care in hypertensive patients. Trials 19 (1) : 658. ScholarBank@NUS Repository.
Rights: Attribution 4.0 International
Abstract: Background: In rural south Asia, hypertension remains a significant public health issue with sub-optimal blood pressure (BP) control rates. The goal of the trial is to evaluate the effectiveness and cost-effectiveness of a multicomponent intervention (MCI) compared to usual care on lowering BP among adults with hypertension in rural south-Asian communities. This article describes the statistical analysis plan for the primary and secondary objectives related to intervention effectiveness based on clinical and patient-reported endpoints. Methods/Design: The study is a cluster randomized trial which will enroll 2550 participants aged ? 40 years with hypertension from rural communities in Bangladesh, Pakistan, and Sri Lanka. The unit of randomization is a cluster defined by 250-300 households. Thirty clusters, 10 from each country, are randomized in a 1:1 ratio to either MCI or usual care, stratified by country and their distance from the clinic. All participants will be assessed every six months over a two-year period after baseline with measurements of systolic and diastolic BP, antihypertensive and statin medication use, medication adherence, physical activity level, anthropometric parameters, smoking status, and dietary habits. The primary objective is to assess the effectiveness of MCI as compared with usual care in terms of mean change in systolic BP from baseline to final follow-up at two years. The primary outcome will be modelled using a generalized linear mixed-model for repeated measures based on a participant-level analysis. The model will include cluster random-effects and will use a non-independence residual correlation matrix to account for repeated measures on the same participant. Sensitivity analyses for the primary endpoint will be based on multiple imputation as well as pattern mixture model tipping point analyses. Secondary outcomes will be analyzed using the same modeling approach as for the primary outcome, with appropriate distributions within the exponential family and corresponding link functions. Discussion: The a priori statistical analysis plan will avoid reporting bias and data-driven analysis for the primary and key secondary outcomes. The results of the study will provide evidence of the benefits and risks of the MCI for BP control in rural communities in south Asian countries with low-resourced public health infrastructure. Trial registration:, NCT02657746. Registered on 14 January 2016. © 2018 The Author(s).
Source Title: Trials
ISSN: 17456215
DOI: 10.1186/s13063-018-3022-8
Rights: Attribution 4.0 International
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