Research Article: SMARThealth India: A stepped-wedge, cluster randomised controlled trial of a community health worker managed mobile health intervention for people assessed at high cardiovascular disease risk in rural India

Date Published: March 26, 2019

Publisher: Public Library of Science

Author(s): David Peiris, Devarsetty Praveen, Kishor Mogulluru, Mohammed Abdul Ameer, Arvind Raghu, Qiang Li, Stephane Heritier, Stephen MacMahon, Dorairaj Prabhakaran, Gari D. Clifford, Rohina Joshi, Pallab K. Maulik, Stephen Jan, Lionel Tarassenko, Anushka Patel, George Liu.


Cardiovascular diseases (CVD) are rising in India resulting in major health system challenges.

Eighteen primary health centre (PHC) clusters in rural Andhra Pradesh were randomised over three, 6-month steps to an intervention comprising: (1) household CVD risk assessments by village-based community health workers (CHWs) using a mobile tablet device; (2) electronic referral and clinical decision support for PHC doctors; and (3) a tracking system for follow-up care. Independent data collectors screened people aged ≥ 40 years in 54 villages serviced by the PHCs to create a high CVD risk cohort (based on WHO risk charts and blood pressure thresholds). Randomly selected, independent samples, comprising 15% of this cohort, were reviewed at each 6-month step. The primary outcome was the proportion meeting systolic blood pressure (SBP) targets (<140mmHg). Eight-four percent of the eligible population (n = 62,254) were assessed at baseline (18.4% at high CVD risk). Of those at high risk, 75.3% were followed up over two years. CHWs screened 85.9% of the baseline cohort and doctors followed up 70.0% of all high risk referrals. There was no difference in the proportion of people achieving SBP targets (41.2% vs 39.2%; adjusted odds ratio (OR) 1.01 95% CI 0.76–1.35) or receiving BP-lowering medications in the intervention vs control periods respectively. There was a high discordance in risk scores generated by independent data collectors and CHWs, resulting in only 37.2% of the evaluation cohort exposed to the intervention. This discordance was mainly driven by fluctuating BP values (both normal variability and marked seasonal variations). In the pre-specified high risk concordant subgroup, there was greater use of BP-lowering medications in the intervention period (54.3% vs 47.9%, OR 1.22, 95% CI 1.03–1.44) but no impact on BP control. The strategy was well implemented with increased treatment rates among high risk individuals assessed by CHWs, however effects on BP were not demonstrated. Use of guideline-recommended BP thresholds for identifying high risk individuals substantially affected the reproducibility of risk assessment, and thus the ability to reliably evaluate the effectiveness of the intervention. In addition, unanticipated seasonal variation in BP in the context of a stepped-wedge trial highlights the inherent risks of this study design. Clinical Trials Registry of India CTRI/2013/06/ 003753.

Partial Text

Cardiovascular diseases (CVD) are a major cause of premature morbidity and mortality globally, with ischemic heart disease and stroke responsible for 24% of all deaths.[1] In India, although there are challenges with data quality, the number of years of life lost because of coronary heart disease deaths before the age of 60 years is projected to increase from 7·1 million in 2004 to 17·9 million in 2030, more life years lost than is projected for China, Russia, and the USA combined.[2] Elevated blood pressure (BP) is a major contributor to the increasing burden of CVD in India, causing almost a million deaths annually.[2] India has an estimated 140 million people diagnosed with hypertension with projections indicating an increase to 213 million by 2025.[3] In rural areas (defined by the Reserve Bank of India as tier-3 to tier-6 cites <50,000 people), where almost 70% of the country’s population resides, high levels of hypertension and other CVD risk factors exist and CVD is the leading cause of adult deaths.[4–6] Fig 2 outlines the study flow. Participants were recruited in June 2014 and follow-up data collection was completed in August 2016. In total 11,484 people were identified to be high risk at baseline and 8,642 of these (75.3%) were followed up over the four subsequent data collection time points with an average cluster size of 120 per PHC included in the analysis. This included 4294 who were followed up in the control period and 4348 who were followed up in the intervention period. Table 2 outlines the baseline characteristics for these two groups. Overall there were few differences in the two samples. This study was a large scale trial of a complex intervention involving task-sharing between doctors and village-based community health workers using mHealth decision support. It was not effective in improving BP control rates for people at high CVD risk. Given the mHealth literature is dominated by small studies that are often not rigorously conducted, the findings from this trial are important. Despite great promise for mHealth interventions to improve access to effective health care, there remains considerable uncertainty about how this can be successfully achieved. These uncertainties pose substantial dilemmas for health system planners, particularly in LMICs, who are looking for affordable strategies to improve access to high quality health care in underserved regions.   Source:


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