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

• Type of Material: Article
• Authors: David Peiris, University of New South Wales; Devarsetty Praveen, University of New South Wales; Kishor Mogulluru, George Institute for Global Health India; Mohammed Abdul Ameer, George Institute for Global Health India; Arvind Raghu, University of Oxford; Qiang Li, University of New South Wales; Stephane Heritier, Monash University; Stephen MacMahon, University of New South Wales; Dorairaj Prabhakaran, Centre for Chronic Disease Control; Gari Clifford, Emory University; Rohina Joshi, University of New South Wales; Pallab K. Maulik, University of New South Wales; Stephen Jan, University of New South Wales; Lionel Tarassenko, University of Oxford; Anushka Patel, University of New South Wales
• Language: English
• Date: 2019-03-26
• Publisher: Public Library of Science
• Publication Version: Final Published Version
• Copyright Statement: © 2019 Peiris et al.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1371/journal.pone.0213708
• Title of Journal or Parent Work: PLoS ONE
• ISSN: 1932-6203
• Volume: 14
• Issue: 3
• Start Page: e0213708
• End Page: e0213708
• Grant/Funding Information: This study was funded by an Australian National Health and Medical Research Council (NHMRC) Global Alliances for Chronic Disease Grant (ID1040147).; AR was supported by the Wellcome Trust and EPSRC under grant number WT 088877/Z/09/Z (Oxford Centre of Excellence in Medical Engineering).; RJ is supported by a National Heart Foundation Future Leader Fellowship.; DaP, AP and SJ are supported by NHMRC Fellowships.; DeP was supported by the Australian Agency for International Development (AusAID).; PM is an Intermediate Career Fellow of The Wellcome Trust/DBT India Alliance.
• Keywords: Multidisciplinary Sciences; Science & Technology - Other Topics; GEE; PREVENTION; MORTALITY; PREVALENCE; HYPERTENSION; DEATH; AWARENESS; Science & Technology
• Research Categories: Health Sciences, Public Health; Health Sciences, Hygiene; Engineering, Biomedical

Abstract

Background Cardiovascular diseases (CVD) are rising in India resulting in major health system challenges. Methods 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). Findings 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. Conclusions 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.