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Global health
Protocol
Cluster randomised feasibility trial to improve the Control of Hypertension In Rural India (CHIRI): a study protocol
  1. Michaela A Riddell1,
  2. Rohina Joshi2,
  3. Brian Oldenburg3,
  4. Clara Chow2,4,
  5. K R Thankappan5,
  6. Ajay Mahal6,7,
  7. Nihal Thomas8,
  8. Velandai K Srikanth1,
  9. Roger G Evans9,10,
  10. Kartik Kalyanram11,
  11. Kamakshi Kartik11,
  12. Pallab K Maulik12,13,
  13. Simin Arabshahi1,
  14. R P Varma5,
  15. Rama K Guggilla12,
  16. Oduru Suresh2,11,
  17. G K Mini5,
  18. Fabrizio D'Esposito3,
  19. Thirunavukkarasu Sathish3,
  20. Mohammed Alim12,
  21. Amanda G Thrift1
  1. 1School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia
  2. 2The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia
  3. 3Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia
  4. 4Department of Cardiology, Westmead Hospital, Sydney, New South Wales, Australia
  5. 5Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India
  6. 6School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia
  7. 7Nossal Institute for Global Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia
  8. 8Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India
  9. 9Department of Physiology, Monash University, Melbourne, Australia
  10. 10Cardiovascular Disease Program, Biosciences Discovery Institute, Monash University, Melbourne, Australia
  11. 11Rishi Valley Rural Health Centre, Chittoor District, Andhra Pradesh, India
  12. 12George Institute for Global Health, Hyderabad, Telangana, India
  13. 13George Institute for Global Health, Oxford University, Oxford, UK
  1. Correspondence to Professor Amanda Thrift; amanda.thrift{at}monash.edu

Abstract

Introduction Hypertension is emerging in rural populations of India. Barriers to diagnosis and treatment of hypertension may differ regionally according to economic development. Our main objectives are to estimate the prevalence, awareness, treatment and control of hypertension in 3 diverse regions of rural India; identify barriers to diagnosis and treatment in each setting and evaluate the feasibility of a community-based intervention to improve control of hypertension.

Methods and analysis This study includes 4 main activities: (1) assessment of risk factors, quality of life, socioeconomic position and barriers to changes in lifestyle behaviours in ∼14 500 participants; (2) focus group discussions with individuals with hypertension and indepth interviews with healthcare providers, to identify barriers to control of hypertension; (3) use of a medicines-availability survey to determine the availability, affordability and accessibility of medicines and (4) trial of an intervention provided by Accredited Social Health Activists (ASHAs), comprising group-based education and support for individuals with hypertension to self-manage blood pressure. Wards/villages/hamlets of a larger Mandal are identified as the primary sampling unit (PSU). PSUs are then randomly selected for inclusion in the cross-sectional survey, with further randomisation to intervention or control. Changes in knowledge of hypertension and risk factors, and clinical and anthropometric measures, are assessed. Evaluation of the intervention by participants provides insight into perceptions of education and support of self-management delivered by the ASHAs.

Ethics and dissemination Approval for the overall study was obtained from the Health Ministry's Screening Committee, Ministry of Health and Family Welfare (India), institutional review boards at each site and Monash University. In addition to publication in peer-reviewed articles, results will be shared with federal, state and local government health officers, local healthcare providers and communities.

Trial registration number CTRI/2016/02/006678; Pre-results.

  • prevalence
  • clinical trial
  • EDUCATION & TRAINING (see Medical Education & Training)
  • India
  • self-management

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-012404

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    Footnotes

    • Contributors MAR wrote the first draft of the manuscript. AGT is the principal investigator, and conceived the study. All authors provided input into the study design, provided intellectual input to the manuscript and approved the final version of the manuscript.

    • Funding This work was funded by The National Health and Medical Research Council (NHMRC) under the Global Alliance for Chronic Disease (GACD) programme (grant number GNT1040030), with additional funds provided from Monash University (via the principal investigator). AGT reports grants from National Health and Medical Research Council of Australia (GNT1040030 and GNT1042600), and grants from Monash University, during the conduct of the study. PKM reports receiving an Intermediate Career Fellowship from the Wellcome Trust/DBT India Alliance, during the conduct of the study. RJ was supported by a fellowship from the National Heart Foundation (GNT100484). AM, NT and SA report grants from National Health and Medical Research Council of Australia, during the conduct of the study. RGE reports receiving grant funding from the National Health and Medical Research Council of Australia.

    • Disclaimer The funders had no role in the design or conduct of the study, and no role in the decision to submit the protocol for publication.

    • Competing interests None declared.

    • Ethics approval Approval for the overall study was obtained from the Health Ministry's Screening Committee, Ministry of Health & Family Welfare, Government of India (No. 58/4/Indo_CHR/2013/NCD-II) and Monash University Human Research Ethics Committee (MUHREC number 2013001327). Each site obtained ethics approval from individual governing institutional review boards (IRBs) for site specific aspects of the study. The site in Trivandrum obtained approval from Sree Chitra Tirunal Institute for Medical Sciences and Technology Institutional Ethics Committee (IEC registration number ECR/189/Inst/KL/2013). The West Godavari site obtained approval from the Centre for Chronic Disease Control, New Delhi (IEC: IRB00006330). The Rishi Valley site obtained approval from the IRBs of the Rishi Valley Education Centre and Christian Medical Centre, Vellore (IRB Min No. 8313). Prior to inclusion in the survey, Sarpanches are approached to obtain approval for the study team to seek participation from the residents of the village in the study.

    • Provenance and peer review Not commissioned; externally peer reviewed.