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Open Access 01-12-2022 | Myocardial Infarction | Study protocol

Mobile app and digital system for patients after myocardial infarction (afterAMI): study protocol for a randomized controlled trial

Authors: Bartosz Krzowski, Michał Peller, Maria Boszko, Paulina Hoffman, Natalia Żurawska, Karolina Jaruga, Kamila Skoczylas, Gabriela Osak, Łukasz Kołtowski, Marcin Grabowski, Grzegorz Opolski, Paweł Balsam

Published in: Trials | Issue 1/2022

Abstract

Background

Treatment of acute myocardial infarction has been the subject of studies over the past years. However, the initial months after myocardial infarction are crucial from the perspective of the patient’s prognosis. It is extremely important to take care of all cardiovascular risk factors and undergo a full rehabilitation program. Telemedical solutions are becoming more and more relevant in everyday practice. We describe a protocol of a study evaluating the use of the mobile application “afterAMI” in patients after myocardial infarction. The app offers an educational mode, calendar, vital signs diary, medication reminders, medical history card, and healthcare professional contact panel. It offers several solutions, which individually proved to be effective and improve a patient’s prognosis. Despite general promising results from previous studies regarding telemedical tools, there is a paucity of evidence when it comes to prospective randomized trials. Our aim was to perform a comprehensive evaluation of a newly developed mobile application in the clinical setting.

Methods

A group of 100 patients with myocardial infarction on admission at the 1st Chair and Department of Cardiology, Medical University of Warsaw, will be recruited into the study. The project aims to assess the impact of the application-supported model of care in comparison with standard rehabilitation. At the end of the study, cardiovascular risk factors will be analyzed, along with rehospitalizations, the patients’ knowledge regarding cardiovascular risk factors, returning to work, and quality of life. In this prospective, open-label, randomized, single-center study, all 100 patients will be observed for 6 months after discharge from the hospital. Endpoints will be assessed during control visits 1 and 6 months after inclusion into the study.

Discussion

This project is an example of a telemedical solution application embracing everyday clinical practices, conforming with multiple international cardiac societies’ guidelines. Cardiac rehabilitation process enhancements are required to improve patients’ prognosis. The evidence regarding the use of the mobile application in the described group of patients is limited and usually covers a small number of participants. The described study aims to discuss whether telemedicine use in this context is beneficial for the patients.

Trial registration

ClinicalTrials.govNCT04793425. Registered on 11 March 2021.

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Degano IR, Salomaa V, Veronesi G, Ferrieres J, Kirchberger I, Laks T, et al. Twenty-five-year trends in myocardial infarction attack and mortality rates, and case-fatality, in six European populations. Heart. 2015;101(17):1413–21.CrossRef

Santos IS, Goulart AC, Brandao RM, Santos RC, Bittencourt MS, Sitnik D, et al. One-year Mortality after an Acute Coronary Event and its Clinical Predictors: The ERICO Study. Arq Bras Cardiol. 2015;105(1):53–64.PubMedPubMedCentral

Authors/Task Force M, Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts): Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur J Prev Cardiol. 2016;23(11):NP1–NP96.CrossRef

Jankowski P, Kosior DA, Sowa P, Szostak-Janiak K, Koziel P, Krzykwa A, et al. Secondary prevention of coronary artery disease in Poland. Results from the POLASPIRE survey. Cardiol J. 2020;27(5):533–40.PubMedPubMedCentral

Robert Jay Widmer TA, Lerman L, Lerman A. The augmentation of usual cardiac rehabilitation with an online and smartphone-based program improves cardiovascular risk factors and reduces rehospitalizations. J Am Coll Cardiol. 2014;63(12 Supplement):A1296.CrossRef

Gallagher R, Roach K, Sadler L, Glinatsis H, Belshaw J, Kirkness A, et al. Mobile technology use across age groups in patients eligible for cardiac rehabilitation: survey study. JMIR Mhealth Uhealth. 2017;5(10):e161.CrossRef

Coorey GM, Neubeck L, Mulley J, Redfern J. Effectiveness, acceptability and usefulness of mobile applications for cardiovascular disease self-management: Systematic review with meta-synthesis of quantitative and qualitative data. Eur J Prev Cardiol. 2018;25(5):505–21.CrossRef

Piotrowicz R, Grabowski M, Balsam P, Koltowski L, Kozierkiewicz A, Zajdel J, et al. “Baltic Declaration”--telemedicine and mHealth as support for clinical processes in cardiology. The opinion of the Committee of Informatics and Telemedicine of the Polish Society of Cardiology and Telemedicine Clinical Sciences Committee of the PAS. Kardiol Pol. 2015;73(7):575–84.CrossRef

Steinberg JS, Varma N, Cygankiewicz I, Aziz P, Balsam P, Baranchuk A, et al. 2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry. Heart Rhythm. 2017;14(7):e55–96.CrossRef

10.

Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, et al. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018;72(18):2231–64.CrossRef

11.

Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021;42(34):3227–337.CrossRef

12.

Bashi N, Fatehi F, Fallah M, Walters D, Karunanithi M. Self-Management Education Through mHealth: Review of Strategies and Structures. JMIR Mhealth Uhealth. 2018;6(10):e10771.CrossRef

13.

Frederix I, Hansen D, Coninx K, Vandervoort P, Vandijck D, Hens N, et al. Medium-Term Effectiveness of a Comprehensive Internet-Based and Patient-Specific Telerehabilitation Program With Text Messaging Support for Cardiac Patients: Randomized Controlled Trial. J Med Internet Res. 2015;17(7):e185.CrossRef

14.

Marquez Contreras E, Marquez Rivero S, Rodriguez Garcia E, Lopez-Garcia-Ramos L, Carlos Pastoriza Vilas J, Baldonedo Suarez A, et al. Specific hypertension smartphone application to improve medication adherence in hypertension: a cluster-randomized trial. Curr Med Res Opin. 2019;35(1):167–73.CrossRef

15.

Ambrosetti M, Abreu A, Corra U, Davos CH, Hansen D, Frederix I, et al. Secondary prevention through comprehensive cardiovascular rehabilitation: From knowledge to implementation. 2020 update. A position paper from the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2020;2047487320913379.

16.

Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, et al. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020;41(3):407–77.CrossRef

17.

Collaboration NCDRF. Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19.1 million participants. Lancet. 2017;389(10064):37–55.CrossRef

18.

Rosendorff C, Lackland DT, Allison M, Aronow WS, Black HR, Blumenthal RS, et al. Treatment of hypertension in patients with coronary artery disease: a scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension. Circulation. 2015;131(19):e435–70.CrossRef

19.

Colivicchi F, Mocini D, Tubaro M, Aiello A, Clavario P, Santini M. Effect of smoking relapse on outcome after acute coronary syndromes. Am J Cardiol. 2011;108(6):804–8.CrossRef

20.

Authors/Task Force M, Guidelines ESCCfP, Societies ESCNC. ESC/EAS guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk. Atherosclerosis. 2019;2019(290):140–205.

21.

Cholesterol Treatment Trialists C, Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670–81.CrossRef

22.

Hofer S, Lim L, Guyatt G, Oldridge N. The MacNew Heart Disease health-related quality of life instrument: a summary. Health Qual Life Outcomes. 2004;2:3.CrossRef

23.

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.CrossRef

24.

Osman A, Wong JL, Bagge CL, Freedenthal S, Gutierrez PM, Lozano G. The Depression Anxiety Stress Scales-21 (DASS-21): further examination of dimensions, scale reliability, and correlates. J Clin Psychol. 2012;68(12):1322–38.CrossRef

25.

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2020.

26.

Piotrowicz R, Krzesinski P, Balsam P, Kempa M, Glowczynska R, Grabowski M, et al. Cardiology telemedicine solutions - opinion of the experts of the Committee of Informatics and Telemedicine of Polish Society of Cardiology, Section of Non-invasive ELECTROCARDIOLOGY and Telemedicine of Polish Society of Cardiology and Clinical Sciences C. Kardiol Pol. 2018;76(3):698–707.CrossRef

27.

Johnston N, Bodegard J, Jerstrom S, Akesson J, Brorsson H, Alfredsson J, et al. Effects of interactive patient smartphone support app on drug adherence and lifestyle changes in myocardial infarction patients: A randomized study. Am Heart J. 2016;178:85–94.CrossRef

Title: Mobile app and digital system for patients after myocardial infarction (afterAMI): study protocol for a randomized controlled trial
Authors: Bartosz Krzowski
Michał Peller
Maria Boszko
Paulina Hoffman
Natalia Żurawska
Karolina Jaruga
Kamila Skoczylas
Gabriela Osak
Łukasz Kołtowski
Marcin Grabowski
Grzegorz Opolski
Paweł Balsam
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Myocardial Infarction
Telemedicine
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06463-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Mobile app and digital system for patients after myocardial infarction (afterAMI): study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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