title: 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).
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Clinical Research & Training, St John's Research Institute, Bengaluru, India.
authors.forename: Deepak Y
authors.initials: DY
authors.lastname: Kamath
authors.affiliation: Division of Clinical Research & Training, St John's Research Institute, Bengaluru, India. Electronic address: denis@sjri.res.in.
authors.forename: Denis
authors.initials: D
authors.lastname: Xavier
authors.affiliation: Department Internal Medicine, Fortis Escorts Hospital, Jaipur, Rajasthan, India.
authors.forename: Rajeev
authors.initials: R
authors.lastname: Gupta
authors.affiliation: Department of Medicine, Division of Cardiology & Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: P J
authors.initials: PJ
authors.lastname: Devereaux
authors.affiliation: Division of Clinical Research & Training, St John's Research Institute, Bengaluru, India.
authors.forename: Alben
authors.initials: A
authors.lastname: Sigamani
authors.affiliation: General Internal Medicine & CVD Fellow, Johns Hopkins Medical Institutions, Baltimore, MD.
authors.forename: Tanvir
authors.initials: T
authors.lastname: Hussain
authors.affiliation: Department of Medicine, St John's Medical College & Hospital, Bengaluru, India.
authors.forename: Sowmya
authors.initials: S
authors.lastname: Umesh
authors.affiliation: Division of Clinical Research & Training, St John's Research Institute, Bengaluru, India.
authors.forename: Freeda
authors.initials: F
authors.lastname: Xavier
authors.affiliation: Division of Clinical Research & Training, St John's Research Institute, Bengaluru, India.
authors.forename: Preeti
authors.initials: P
authors.lastname: Girish
authors.affiliation: Division of Clinical Research & Training, St John's Research Institute, Bengaluru, India.
authors.forename: Nisha
authors.initials: N
authors.lastname: George
authors.affiliation: Department of Biostatistics, St John's Medical College, Bengaluru, India.
authors.forename: Tinku
authors.initials: T
authors.lastname: Thomas
authors.affiliation: Department of Medicine, Rajah Muthiah Medical College, Annamalainagar, Tamil Nadu, India.
authors.forename: N
authors.initials: N
authors.lastname: Chidambaram
authors.affiliation: Department of Internal Medicine, All India Institute of Medical Sciences (AIIMS), Bhopal, India.
authors.forename: Rajnish
authors.initials: R
authors.lastname: Joshi
authors.affiliation: Division of Clinical Research & Training, St John's Research Institute, Bengaluru, India.
authors.forename: Prem
authors.initials: P
authors.lastname: Pais
authors.affiliation: Population Health Research Institute, Heart & Stroke Foundation/Marion W. Burke Chair in Cardiovascular Diseases, McMaster University, Hamilton Health Sciences, Ontario, Canada.
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
mesh_terms: D054058:Acute Coronary Syndrome / Q000517:prevention & control*; D000328:Adult; D000368:Aged; D001794:Blood Pressure; D015992:Body Mass Index; D003153:Community Health Services / Q000379:methods*; D003150:Community Health Workers; D005260:Female; D006339:Heart Rate; D006801:Humans; D007194:India; D008055:Lipids / Q000097:blood; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D012107:Research Design; D040242:Risk Reduction Behavior; D055502:Secondary Prevention / Q000379:methods*; D012648:Self Care; D016896:Treatment Outcome
chemical_list: D008055:Lipids