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Am Heart J. 2014 Nov;168(5):690-7. doi: 10.1016/j.ahj.2014.07.029. Epub 2014 Aug 10.

Rationale and design of a randomized controlled trial evaluating community health worker-based interventions for the secondary prevention of acute coronary syndromes in India (SPREAD).

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Division of Clinical Research & Training, St John's Research Institute, Bengaluru, India.
Division of Clinical Research & Training, St John's Research Institute, Bengaluru, India. Electronic address:
Department Internal Medicine, Fortis Escorts Hospital, Jaipur, Rajasthan, India.
Department of Medicine, Division of Cardiology & Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada.
General Internal Medicine & CVD Fellow, Johns Hopkins Medical Institutions, Baltimore, MD.
Department of Medicine, St John's Medical College & Hospital, Bengaluru, India.
Department of Biostatistics, St John's Medical College, Bengaluru, India.
Department of Medicine, Rajah Muthiah Medical College, Annamalainagar, Tamil Nadu, India.
Department of Internal Medicine, All India Institute of Medical Sciences (AIIMS), Bhopal, India.
Population Health Research Institute, Heart & Stroke Foundation/Marion W. Burke Chair in Cardiovascular Diseases, McMaster University, Hamilton Health Sciences, Ontario, Canada.



There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease. There are no studies from low- to middle income countries (LMICs) evaluating trained community health worker (CHW)-based interventions for the secondary prevention of coronary heart disease.


We designed a hospital-based, open randomized trial of CHW-based interventions versus standard care. Patients after an acute coronary syndrome (ACS) were randomized to an intervention group (a CHW-based intervention package, comprising education tools to enhance self-care and adherence, and regular follow-up by the CHW) or to standard care for 12 months during which study outcomes were recorded. The CHWs were trained over a period of 6 months. The primary outcome measure was medication adherence. The secondary outcomes were differences in adherence to lifestyle modification, physiological parameters (blood pressure [BP], body weight, body mass index [BMI], heart rate, lipids), and major adverse cardiovascular events.


We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities. The mean age was 56.4 (± 11.32) years, and 17.2% were females. A high prevalence of risk factors such as hypertension (43.4%), diabetes (31.9%), tobacco consumption (35.4%), and inadequate physical activity (70.5%) was documented. A little over half had ST-elevation myocardial infarction (53.7%), and 46.3% had non-ST-elevation myocardial infarction or unstable angina.


The CHW interventions and training for SPREAD have been developed and adapted for local use. The results and experience of this study will be important to counter the burden of cardiovascular diseases in low- to middle income countries.

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