Study of a Community Based Approach to Control Cardiovascular Risk Factors in India
Condition: Hypertension; Diabetes; Smoking; Cardiovascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases
Study type: Interventional

Summary: 
      The study is a 2 year community based cluster randomized controlled trial to assess the role
      that a community health worker led intervention, in concert with physician education, can
      play in controlling the principal cardiovascular risk factors, i.e. hypertension, tobacco
      use, diabetes mellitus, physical inactivity and an unhealthy diet. Participants will include
      around 3600 adults, 35-70 years of age, from the urban community in the town of Dalkhola,
      Uttar Dinajpur district, West Bengal, India. The hypothesis of the study is that a community
      health worker based approach can result in increased control of Hypertension, Diabetes and
      Smoking.
    

Detailed description: 
      India is currently in the throes of an emerging epidemic of cardiovascular diseases as
      evidenced by the rising trends in hypertension, smoking and diabetes prevalence observed in
      the past decade. The country is currently ill equipped to handle this massive problem of
      chronic diseases. One of the proposed models to address this problem at the primary care
      level is to expand the pre-existing infrastructure of community health workers that deliver
      maternal and child health care for screening and management of NCDs. The investigators
      propose a cluster randomized control study to test the effectiveness of community health
      workers (CHW) in controlling the three most prevalent cardiovascular risk factors in an
      integrated manner - hypertension, smoking and diabetes.

      The investigators plan to screen around 3600 individuals between the age of 35 and 70 for
      hypertension, diabetes and smoking from 12 randomly selected clusters in the economically
      backward urban town of Dalkhola (WB). The screening will be done using house to house visits
      by CHWs who will administer a questionnaire based on the WHO STEPS survey, measure individual
      blood pressures and fasting blood glucose. The individuals identified as having atleast one
      of these risk factors will be eligible for further participation in the study. The clusters
      will be randomized to either receive the CHW intervention or usual care.

      CHWs will be used as the change agents to provide health education, serve as community
      advocates, and collect data for this study .These CHWs will be chosen from the study
      population based on a set of criteria through a formal selection panel after consulting with
      the local leaders and physicians. They will undergo a week of training for the screening
      process, an additional week for the intervention and finally a refresher course every 6
      months. The CHW remunerations will be based on a system of incentives ranging from a minimum
      of Rs. 12,000 p.a to a maximum of 20,000 p.a.

      The intervention is a multi-component one that is tailored to the individual and will target
      lifestyle changes, health seeking behavior and medication compliance. The CHW intervention
      will be implemented in a phased manner (2 phases) as is appropriate for multi-component
      interventions. The CHW after identifying the cardiovascular risk factors will give advice
      about lifestyle interventions and information about cardiovascular diseases and the benefits
      of treatment in a one hour session. She will tailor the daily family menu and make
      appropriate dietary recommendations within the economic context of the family. She will
      encourage hypertensives and diabetics to seek a physician. The first phase of the
      intervention will target hypertension, while the second phase which will be introduced 6
      months after the first visit will target diabetes and smoking. The CHW will continue visiting
      the home of the participants every 2 months to reinforce the previous recommendations, seek
      to address reasons for non-adherence, address knowledge deficits and encourage physician
      visits. The control group, during their screening visit, will be informed of their problems,
      given a brief pamphlet and encouraged to seek physician help.
    

Intervention name(s): Community health worker
Intervention type(s): Behavioral
Intervention description(s): The intervention is a multi-component one that is tailored to the individual and will target lifestyle changes, health seeking behavior and medication compliance. The CHW, after identifying the cardiovascular risk factors, will give advice about lifestyle interventions and will encourage hypertensives and diabetics to seek a physician. The first phase of the intervention will target hypertension, while the second phase which will be introduced 6 months after the first visit will target diabetes and smoking. The CHW will continue visiting the home of the participants every 2 months to reinforce the previous recommendations, seek to address reasons for non-adherence, address knowledge deficits and encourage physician visits.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: India; Cardiovascular risk factors; Community health workers; Hypertension; Diabetes; Smoking