title: Cluster randomised feasibility trial to improve the Control of Hypertension In Rural India (CHIRI): a study protocol.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  CTRI/2016/02/006678; Pre-results.
authors.affiliation: School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
authors.forename: Michaela A
authors.initials: MA
authors.lastname: Riddell
authors.affiliation: The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Rohina
authors.initials: R
authors.lastname: Joshi
authors.affiliation: Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Brian
authors.initials: B
authors.lastname: Oldenburg
authors.affiliation: The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia.|Department of Cardiology, Westmead Hospital, Sydney, New South Wales, Australia.
authors.forename: Clara
authors.initials: C
authors.lastname: Chow
authors.affiliation: Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.
authors.forename: K R
authors.initials: KR
authors.lastname: Thankappan
authors.affiliation: 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.
authors.forename: Ajay
authors.initials: A
authors.lastname: Mahal
authors.affiliation: Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Nihal
authors.initials: N
authors.lastname: Thomas
authors.affiliation: School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
authors.forename: Velandai K
authors.initials: VK
authors.lastname: Srikanth
authors.affiliation: Department of Physiology, Monash University, Melbourne, Australia.|Cardiovascular Disease Program, Biosciences Discovery Institute, Monash University, Melbourne, Australia.
authors.forename: Roger G
authors.initials: RG
authors.lastname: Evans
authors.affiliation: Rishi Valley Rural Health Centre, Chittoor District, Andhra Pradesh, India.
authors.forename: Kartik
authors.initials: K
authors.lastname: Kalyanram
authors.affiliation: Rishi Valley Rural Health Centre, Chittoor District, Andhra Pradesh, India.
authors.forename: Kamakshi
authors.initials: K
authors.lastname: Kartik
authors.affiliation: George Institute for Global Health, Hyderabad, Telangana, India.|George Institute for Global Health, Oxford University, Oxford, UK.
authors.forename: Pallab K
authors.initials: PK
authors.lastname: Maulik
authors.affiliation: School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
authors.forename: Simin
authors.initials: S
authors.lastname: Arabshahi
authors.affiliation: Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.
authors.forename: R P
authors.initials: RP
authors.lastname: Varma
authors.affiliation: George Institute for Global Health, Hyderabad, Telangana, India.
authors.forename: Rama K
authors.initials: RK
authors.lastname: Guggilla
authors.affiliation: The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia.|Rishi Valley Rural Health Centre, Chittoor District, Andhra Pradesh, India.
authors.forename: Oduru
authors.initials: O
authors.lastname: Suresh
authors.affiliation: Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.
authors.forename: G K
authors.initials: GK
authors.lastname: Mini
authors.affiliation: Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: D'Esposito
authors.affiliation: Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Thirunavukkarasu
authors.initials: T
authors.lastname: Sathish
authors.affiliation: George Institute for Global Health, Hyderabad, Telangana, India.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Alim
authors.affiliation: School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
authors.forename: Amanda G
authors.identifier: 0000-0001-8533-4170
authors.initials: AG
authors.lastname: Thrift
mesh_terms: D000328:Adult; D016000:Cluster Analysis; D003153:Community Health Services / Q000458:organization & administration; D003430:Cross-Sectional Studies; D005240:Feasibility Studies; D005260:Female; D017144:Focus Groups; D006297:Health Services Accessibility / Q000458:organization & administration*; D006801:Humans; D006973:Hypertension / Q000453:epidemiology / Q000517:prevention & control* / Q000628:therapy*; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D011788:Quality of Life; D019035:Rural Health Services / Q000458:organization & administration*; D012424:Rural Population; D012648:Self Care; D012959:Socioeconomic Factors
keywords: EDUCATION & TRAINING (see Medical Education & Training); India; clinical trial; prevalence; self-management