title: Rationale and design of a cluster-randomized controlled trial to evaluate the effects of a community health worker-based program for cardiovascular risk factor control in India.
abstract: BACKGROUND
  The increasing burden of cardiovascular disease (CVD) in low- and middle-income countries is largely driven by the increasing prevalence of hypertension, diabetes, and tobacco use. We hypothesize that the utilization of community health workers (CHWs) to screen for and manage these 3 determinants of CVD in an integrated manner would be an effective approach to favorably affecting public health.
  
  
  METHODS
  We have designed and set up the infrastructure to implement a 2-year community-based cluster randomized controlled trial in an underserved region of West Bengal, India. Participants include around 1200 adults, aged between 35 and 70 years, with ≥1 cardiovascular risk factor. They are recruited through home-based screening into a total of 12 clusters, which are randomized to either a control or intervention arm before screening. After the screening, CHWs follow up with participants enrolled in the intervention arm for a period of 2 years through home visits. The control arm receives usual care in the community. The CHW arm follows a behavioral strategy focused on modifying the individual's lifestyle, increasing knowledge of CVD, promoting smoking cessation, increasing physician-seeking behavior, and promoting medication adherence. The main project office is based in Cleveland, OH, at University Hospitals/CWRU, and the local site office is located in Dalkhola, West Bengal, at a local nonprofit set up for the study. Institutional review board approval was obtained both in Cleveland as well as in India.
  The 2-year primary outcome of the study is the absolute reduction in systolic blood pressure among hypertensive participants, absolute reduction in fasting blood glucose among diabetic participants, and absolute reduction in average number of cigarettes smoked per day among smokers.
  
  
  CONCLUSIONS
  We believe that this study infrastructure serves as a useful model for international collaboration. It builds on unique local resources, attends to important domestic requirements, and will ultimately provide an evidence-based approach that will help manage the increasing burden of CVD worldwide.
authors.affiliation: Harrington Heart & Vascular Institute, University Hospitals Case Medical Center, Cleveland, OH. Electronic address: aditya.khetan@uhhospitals.org.
authors.forename: Aditya
authors.initials: A
authors.lastname: Khetan
authors.affiliation: University of Arkansas for Medical Sciences, Little Rock, AR.
authors.forename: Raghunandan
authors.initials: R
authors.lastname: Purushothaman
authors.affiliation: Kent State University, Kent, OH.
authors.forename: Melissa
authors.initials: M
authors.lastname: Zullo
authors.affiliation: All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Rishab
authors.initials: R
authors.lastname: Gupta
authors.affiliation: Harrington Heart & Vascular Institute, University Hospitals Case Medical Center, Cleveland, OH.
authors.forename: Vittal
authors.initials: V
authors.lastname: Hejjaji
authors.affiliation: SEHAT, Dalkhola, India.
authors.forename: Sushil
authors.initials: S
authors.lastname: Agarwal
authors.affiliation: Harrington Heart & Vascular Institute, University Hospitals Case Medical Center, Cleveland, OH; Case Western Reserve University School of Medicine, Cleveland, OH.
authors.forename: Sri Krishna Madan
authors.initials: SK
authors.lastname: Mohan
authors.affiliation: Harrington Heart & Vascular Institute, University Hospitals Case Medical Center, Cleveland, OH; Case Western Reserve University School of Medicine, Cleveland, OH.
authors.forename: Richard
authors.initials: R
authors.lastname: Josephson
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure; D002318:Cardiovascular Diseases / Q000453:epidemiology; D003150:Community Health Workers; D003920:Diabetes Mellitus / Q000188:drug therapy* / Q000453:epidemiology / Q000378:metabolism; D019468:Disease Management; D005260:Female; D006792:House Calls; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007194:India; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010353:Patient Education as Topic; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012907:Smoking / Q000628:therapy*; D016540:Smoking Cessation
chemical_list: D000959:Antihypertensive Agents; D001786:Blood Glucose; D007004:Hypoglycemic Agents