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Observational Study
. 2017 Dec 14;7(12):e017668.
doi: 10.1136/bmjopen-2017-017668.

Study protocol for S martphone M onitoring for A trial fibrillation in R eal- T ime in India (SMART-India): a community-based screening and referral programme

Apurv Soni  1   2 , Sunil Karna  3 , Harshil Patel  4 , Nisha Fahey  5 , Shyamsundar Raithatha  6 , Anna Handorf  2 , John Bostrom  2 , Syed Bashar  7 , Kandarp Talati  4 , Ravi Shah  5 , Robert J Goldberg  1 , Sunil Thanvi  3 , Ajay Gajanan Phatak  4 , Jeroan J Allison  1 , Ki Chon  7 , Somashekhar Marutirao Nimbalkar  4 , David D McManus  1   8
Affiliations
Observational Study

Study protocol for S martphone M onitoring for A trial fibrillation in R eal- T ime in India (SMART-India): a community-based screening and referral programme

Apurv Soni et al. BMJ Open. .

Abstract

Introduction: Atrial fibrillation (AF), the world's most common arrhythmia, often goes undetected and untreated in low-resource communities, including India, where AF epidemiology is undefined. AF is an important risk factor for stroke, which plagues an estimated 1.6 million Indians annually. As such, early detection of AF and management of high-risk patients is critically important to decrease stroke burden in individuals with AF. This study aims to describe the epidemiology of AF in Anand District, Gujarat, India, characterise the clinical profile of individuals who are diagnosed with AF and determine the performance of two mobile technologies for community-based AF screening.

Methods: This observational study builds on findings from a previous feasibility study and leverages two novel technologies as well as an existing community health programme to perform door-to-door AF screening for 2000 people from 60 villages of Anand District, Gujarat, India using local health workers. A single-lead ECG and a pulse-based application is used to screen each individual for AF three times over a period of 5 days. Participants with suspected arrhythmias are followed up by study cardiologist who makes final diagnoses. Participants diagnosed with AF are initiated on treatment based on current anticoagulation guidelines and clinical reasoning.

Analytical plan: Age-stratified and sex-stratified prevalence of AF in the Anand District will be calculated for sample and estimated for Anand distribution using survey design weights. Sociodemographic and clinical factors associated with AF will be evaluated using multivariable regression methods. Performance of each mobile technology in detecting AF will be evaluated using a 12-lead ECG interpretation as the gold standard.

Ethics and dissemination: This protocol was approved separately by the Institutional Review Board of University of Massachusetts Medical School and the Human Research Ethics Committee at Charutar Arogya Mandal. The findings of this study will be disseminated through peer-reviewed journals and scientific conferences.

Keywords: cardiac epidemiology; public health; valvular heart disease.

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Conflict of interest statement

Competing interests: DDMM discloses equity stakes or consulting relationships with Flexcon, Inc., Bristol-Myers Squibb, Inc., Mobile Sense, Inc., ATRIA, Inc. and Boston Biomedical Associates, Inc. He has also received research funding from Sanofi Aventis, Inc., Otsuka Pharmaceuticals, Inc., Philips Healthcare, Inc., Biotronik, Inc. and Pfizer, Inc.

Figures

Figure 1
Figure 1
An overview of SMART-India study protocol for community-based screening of AF and referral for clinical follow-up in rural Western India. AF, atrial fibrillation; ANAND, Automated Novel Atrial fibrillation Noninvasive Detection; app, application; FDA, Food and Drug Administration; SMART-India, Smartphone Monitoring for Atrial fibrillation in Real-Time—India; SPARSH, Shree Krishna Hospital Programme for Advancement of Rural and Social Health.
Figure 2
Figure 2
An overview of data management for SMART-India study. Questionnaire data is collected using Magpi platform, screening files are imported through iTunes, and clinical forms as well as abnormal recordings are stored in REDCap. Logo credit: Magpi Inc (www.home.magpi.com); AliveCor (www.AliveCor.com); Adobe Reader (www.acrobat.adobe.com); iTunes (www.apple.com/itunes); REDCap (www.project-redcap.org); Stata (www.stata.com)
Figure 3
Figure 3
A field worker is collecting single-lead ECG recording from a SMART-India participant. The participant is asked to place her fingers on the AliveCor device that is supported by a clipboard to minimise motion-noise artefact. The participant approved the use of this picture and provided consent for its use. SMART-India, Smartphone Monitoring for Atrial fibrillation in Real-Time—India.
Figure 4
Figure 4
A flow chart describing the clinical decision-making of the study cardiologist for participants following up in clinic for abnormal screening results during SMART-India study. CHA2DS2-VASc, Congestive heart failure, Hypertension, Age 75+ years, Diabetes mellitus, Stroke, Vascular disease, Age 65-74 years, Female sex; HbA1c, glycated haemoglobin; SMART-India, Smartphone Monitoring for Atrial fibrillation in Real-Time—India.
See this image and copyright information in PMC

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