title: A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial.
abstract: BACKGROUND
  Blood Pressure related disease affected 118 million people in India in the year 2000; this figure will double by 2025. Around one in four adults in rural India have hypertension, and of those, only a minority are accessing appropriate care. Health systems in India face substantial challenges to meet these gaps in care, and innovative solutions are needed.
  
  
  METHODS
  We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare. This intervention will be implemented as a stepped wedge, cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk (approximately 15,000 people). Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension's region-specific risk charts. Cluster randomisation will occur at the level of the primary health centres. Outcome analyses will be conducted blinded to intervention allocation.
  
  
  OBJECTIVE
  The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period. Secondary outcomes include mean reduction in blood pressure levels; change in other cardiovascular disease risk factors, including body mass index, current smoking, reported healthy eating habits, and reported physical activity levels; self-reported use of blood pressure and other cardiovascular medicines; quality of life (using the EQ-5D); and cardiovascular disease events (using hospitalisation data). Trial outcomes will be accompanied by detailed process and economic evaluations.
  
  
  CONCLUSIONS
  The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served populations in low and middle income country settings.
  
  
  BACKGROUND
  Clinical Trial Registry India CTRI/2013/06/003753.
authors.affiliation: The George Institute for Global Health, Hyderabad, India. dpraveen@georgeinstitute.org.in.
authors.forename: Devarsetty
authors.initials: D
authors.lastname: Praveen
authors.forename: Anushka
authors.initials: A
authors.lastname: Patel
authors.forename: Stephen
authors.initials: S
authors.lastname: McMahon
authors.forename: Dorairaj
authors.initials: D
authors.lastname: Prabhakaran
authors.forename: Gari D
authors.initials: GD
authors.lastname: Clifford
authors.forename: Pallab K
authors.initials: PK
authors.lastname: Maulik
authors.forename: Rohina
authors.initials: R
authors.lastname: Joshi
authors.forename: Stephen
authors.initials: S
authors.lastname: Jan
authors.forename: Stephane
authors.initials: S
authors.lastname: Heritier
authors.forename: David
authors.initials: D
authors.lastname: Peiris
mesh_terms: D000328:Adult; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D020000:Decision Support Systems, Clinical; D003722:Dental Alloys; D055317:Evidence-Based Practice; D058005:General Practitioners; D006801:Humans; D007194:India; D008875:Middle Aged; D012308:Risk Management; D019035:Rural Health Services; D013685:Telecommunications
chemical_list: D003722:Dental Alloys; C074540:Cluster admixed alloy