Design and rationale for the "Me & My Heart" (eMocial) study: A randomized evaluation of a new smartphone-based support tool to increase therapy adherence of patients with acute coronary syndrome.

Florian Krackhardt,Ralf Degenhardt,Carsten Tschoepe,Matti Ahlqvist,Anna Niklasson,Matthias W Waliszewski,Lars S Maier,Alexander Ghanem,Till Köhler,Karl‐Friedrich Appel,Magnus Jörnten‐Karlsson,Jürgen Vom Dahl

doi:10.1002/clc.23254

Abstract

A novel smartphone‐based patient support tool was developed to increase the adherence to antiplatelet therapy and lifestyle changes in patients after coronary angioplasty for acute coronary syndrome (ACS). The eMocial study (http://clinicaltrials.gov Identifier: NCT02615704) investigates whether an electronic support tool will improve adherence to comedication and lifestyle changes in ACS patients. The primary hypothesis of this trial is that an electronic support tool can increase adherence to comedication (primary endpoint) thereby supporting positive lifestyle changes (secondary endpoints). Patients hospitalized with ACS (ST elevation myocardial infarction [STEMI], non‐ST elevation myocardial infarction [NSTEMI], or unstable angina pectoris) and treated with ticagrelor coadministered with low‐dose acetylsalicylic acid will be randomized 1:1 to an active group receiving the patient support tool via a smartphone‐based application or to a control group without the patient support tool. Patient questionnaires to evaluate lifestyle changes and quality of life will be used at baseline and at the end of the 48‐week observation phase. Patients are asked to fill out questionnaires to determine their adherence, treatment attitudes, health‐care utilization and risk factors on a monthly basis. The study was started in February 2016 and the completion date is scheduled for October 2019. For final analysis 664 patients are expected be available. Preliminary baseline demographics were unstable angina pectoris (13.7%), NSTEMI (49.9%), STEMI (36.4%), male gender (86.3%), and diabetes mellitus (17.6%). Our study could significantly help to understand how inadequate adherence to antiplatelet therapy in ACS patients could be improved with a smartphone‐based application.

Highlights

In the United States, approximately 1 365 000 patients are hospitalized for acute coronary syndrome (ACS) annually.[1]
Patients hospitalized with ACS (ST elevation myocardial infarction [STEMI], non-ST elevation myocardial infarction [NSTEMI], or unstable angina pectoris) and treated with ticagrelor coadministered with low-dose acetylsalicylic acid will be randomized 1:1 to an active group receiving the patient support tool via a smartphone-based application or to a control group without the patient support tool
Our study could significantly help to understand how inadequate adherence to antiplatelet therapy in ACS patients could be improved with a smartphone-based application

Summary

Introduction

In the United States, approximately 1 365 000 patients are hospitalized for acute coronary syndrome (ACS) annually.[1] Despite optimal medical therapy, patients with recent ACS remain at high risk of recurrent coronary events.[2] long-term management for patients discharged after ACS includes lifestyle changes (eg, physical activity plans, smoking cessation, and adherence to a healthy diet), the control of risk factors, and pharmacotherapy using antiplatelet therapy of acetylsalicylic acid (ASA), P2Y12 receptor inhibitors, beta-blockers, statins, angiotensinconverting enzyme inhibitors, or angiotensin receptor blockers.[3]. Therapy adherence tends to be high, whilst adherence in clinical practice is usually lower.[4] A key strategy to enhance adherence is better communication and face-to-face coaching by a health-care professional,[5,6] despite the fact that coaching sessions may not be sustainable from a cost perspective. Digital patient support has been proposed as a potential solution that could be effective at a sustainable cost.[7,8,9]

Objectives

Methods

Conclusion