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移动应用程序和数字系统用于心肌梗死后患者(AMI 后):一项随机对照试验的研究方案。

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

机构信息

1st Chair and Department of Cardiology, Medical University of Warsaw, 02-091, Warsaw, Poland.

出版信息

Trials. 2022 Jun 21;23(1):522. doi: 10.1186/s13063-022-06463-x.

DOI:10.1186/s13063-022-06463-x
PMID:35729626
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9210045/
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.gov NCT04793425 . Registered on 11 March 2021.

摘要

背景

急性心肌梗死的治疗一直是近年来研究的主题。然而,从患者预后的角度来看,心肌梗死后的最初几个月至关重要。照顾所有心血管危险因素并进行全面康复计划非常重要。远程医疗解决方案在日常实践中变得越来越重要。我们描述了一项评估使用移动应用程序“afterAMI”在心肌梗死后患者中应用的研究方案。该应用程序提供教育模式、日历、生命体征日记、药物提醒、病史卡和医疗保健专业人员联系面板。它提供了几种解决方案,这些解决方案单独证明是有效的,可以改善患者的预后。尽管以前的研究对远程医疗工具普遍给出了有希望的结果,但在前瞻性随机试验方面证据仍然不足。我们的目的是在临床环境中对新开发的移动应用程序进行全面评估。

方法

将 100 名在华沙医科大学第一椅子和心脏病学系入院的心肌梗死患者纳入研究。该项目旨在评估应用支持的护理模式与标准康复相比的影响。研究结束时,将分析心血管危险因素、再住院、患者对心血管危险因素的了解、重返工作岗位和生活质量。在这项前瞻性、开放标签、随机、单中心研究中,所有 100 名患者将在出院后 6 个月内进行观察。将在研究纳入后第 1 和第 6 个月的随访中评估终点。

讨论

该项目是一种远程医疗解决方案应用的范例,它采用了日常临床实践,并符合多个国际心脏病学会的指南。需要增强心脏康复过程,以改善患者的预后。关于在描述的患者群体中使用移动应用程序的证据有限,通常涵盖的参与者数量较少。描述的研究旨在讨论在这种情况下使用远程医疗是否对患者有益。

试验注册

ClinicalTrials.gov NCT04793425。于 2021 年 3 月 11 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74de/9210774/d45173660bf8/13063_2022_6463_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74de/9210774/ae8f3e6c78af/13063_2022_6463_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74de/9210774/d45173660bf8/13063_2022_6463_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74de/9210774/ae8f3e6c78af/13063_2022_6463_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74de/9210774/d45173660bf8/13063_2022_6463_Fig2_HTML.jpg

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