The Department of Endocrinology, 
Cluster randomised feasibility trial to improve the Control of Hypertension In Rural India (CHIRI): a study protocol.
- School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
- The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia.
- Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
- Department of Cardiology, Westmead Hospital, Sydney, New South Wales, Australia.
- Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.
- School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.
- Nossal Institute for Global Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
- Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India.
- Department of Physiology, Monash University, Melbourne, Australia.
- Cardiovascular Disease Program, Biosciences Discovery Institute, Monash University, Melbourne, Australia.
- Rishi Valley Rural Health Centre, Chittoor District, Andhra Pradesh, India.
- George Institute for Global Health, Hyderabad, Telangana, India.
- George Institute for Global Health, Oxford University, Oxford, UK.
BMJ open Vol. 6 · Issue 10 · pp. e012404
PMID 27855099 DOI 10.1136/bmjopen-2016-012404
Cite This Article
Michaela A Riddell, Rohina Joshi, Brian Oldenburg, Clara Chow, K R Thankappan, Ajay Mahal, Nihal Thomas, Velandai K Srikanth, Roger G Evans, Kartik Kalyanram, Kamakshi Kartik, Pallab K Maulik, Simin Arabshahi, R P Varma, Rama K Guggilla, Oduru Suresh, G K Mini, Fabrizio D'Esposito, Thirunavukkarasu Sathish, Mohammed Alim, Amanda G Thrift. Cluster randomised feasibility trial to improve the Control of Hypertension In Rural India (CHIRI): a study protocol. BMJ open. 2016;6(10):e012404. doi:10.1136/bmjopen-2016-012404
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.
Keywords
- EDUCATION & TRAINING (see Medical Education & Training)
- India
- clinical trial
- prevalence
- self-management
