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

BackgroundBlood 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.MethodsWe 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.Expected outcomesThe 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.SignificanceThe 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.Trial registrationClinical Trial Registry India CTRI/2013/06/003753.

Implementation of Patient-Centered Education for Chronic-Disease Management in Uganda: An Effectiveness Study

“…Interventions aimed at incorporating patient-centered NCD management within existing community-based health efforts, traditionally oriented towards infectious disease and malnutrition, may prove to be both cost-effective and transformative [30]. New technologies such as m-health (mobile phone-based health technology) may allow for implementation of patient-centered care directly in rural communities [31, 32]. As with any new health system intervention, the ideal program should be low-cost, require minimal input of new resources, culturally acceptable, and scalable.…”

Cardiovascular Diseases in India

“…129 In addition, a multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in CVD risk management has been developed and was implemented in 18 primary health centers and 54 villages in rural Andhra Pradesh involving ≈15 000 adults aged ≥40 years at high CVD event risk. 127 The results of these studies have the potential to inform policy on scalable strategies to improve the efficiency of the health system in managing CVD. The trial identified no effect of the health promotion strategy on the primary knowledge outcome.…”

Innovative Approaches to Hypertension Control in Low- and Middle-Income Countries

“…All the studies supported NPHWs by training them for two to six days, followed by re-training where required. 14, 54, 55 Some studies facilitated task redistribution by using mHealth technology, 14, 56 whereby NPHWs used electronic decision support tools to screen individuals in the community and link them to hypertension care. Process and interim evaluations have identified that the main barriers to task-redistribution include resistance from other health professionals; increasing NPHW workload due to additional tasks; complexity of training materials; health system-related issues such as non-availability or non-functioning BP machines, poor drug supply, lack of physician availability for referral; regulatory restrictions including the inability to prescribe medications; and low remuneration of NPHWs.…”