Mobile app and digital system for patients after myocardial infarction (afterAMI): study protocol for a randomized controlled trial.
Acute myocardial infarction
Cardiac rehabilitation
Mobile application
Telehealth
Telemedicine
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
21 Jun 2022
21 Jun 2022
Historique:
received:
14
09
2021
accepted:
09
06
2022
entrez:
21
6
2022
pubmed:
22
6
2022
medline:
24
6
2022
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov NCT04793425 . Registered on 11 March 2021.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov NCT04793425 . Registered on 11 March 2021.
Identifiants
pubmed: 35729626
doi: 10.1186/s13063-022-06463-x
pii: 10.1186/s13063-022-06463-x
pmc: PMC9210045
doi:
Banques de données
ClinicalTrials.gov
['NCT04793425']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
522Subventions
Organisme : Warszawski Uniwersytet Medyczny
ID : MB/M/26(47)
Informations de copyright
© 2022. The Author(s).
Références
J Clin Psychol. 2012 Dec;68(12):1322-38
pubmed: 22930477
Curr Med Res Opin. 2019 Jan;35(1):167-173
pubmed: 30431384
Eur J Prev Cardiol. 2020 Apr 07;:
pubmed: 33611446
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
JMIR Mhealth Uhealth. 2017 Oct 24;5(10):e161
pubmed: 29066425
Arq Bras Cardiol. 2015 Jul;105(1):53-64
pubmed: 25993485
Eur Heart J. 2021 Feb 1;42(5):373-498
pubmed: 32860505
Heart Rhythm. 2017 Jul;14(7):e55-e96
pubmed: 28495301
Kardiol Pol. 2015;73(7):575-84
pubmed: 26189477
Eur Heart J. 2020 Jan 14;41(3):407-477
pubmed: 31504439
Heart. 2015 Sep;101(17):1413-21
pubmed: 25855798
Lancet. 2017 Jan 7;389(10064):37-55
pubmed: 27863813
Circulation. 2015 May 12;131(19):e435-70
pubmed: 25829340
Lancet. 2010 Nov 13;376(9753):1670-81
pubmed: 21067804
Am J Cardiol. 2011 Sep 15;108(6):804-8
pubmed: 21741609
Eur Heart J. 2021 Sep 7;42(34):3227-3337
pubmed: 34458905
Am Heart J. 2016 Aug;178:85-94
pubmed: 27502855
Cardiol J. 2020;27(5):533-540
pubmed: 32436589
J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264
pubmed: 30153967
Kardiol Pol. 2018;76(3):698-707
pubmed: 29441511
JMIR Mhealth Uhealth. 2018 Oct 19;6(10):e10771
pubmed: 30341042
Eur J Prev Cardiol. 2016 Jul;23(11):NP1-NP96
pubmed: 27353126
Eur J Prev Cardiol. 2018 Mar;25(5):505-521
pubmed: 29313363
Health Qual Life Outcomes. 2004 Jan 08;2:3
pubmed: 14713315
J Med Internet Res. 2015 Jul 23;17(7):e185
pubmed: 26206311
Atherosclerosis. 2019 Nov;290:140-205
pubmed: 31591002