Rationale and Design of a Study to Assess the Engagement and Usefulness of the Care4Today Connect Digital Health Application for Disease Management in Coronary Artery Disease and Peripheral Artery Disease (iPACE-CVD Study)

IF 2.4 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Clinical Cardiology Pub Date : 2024-12-11 DOI:10.1002/clc.70039
Dhanunjaya Lakkireddy, Dominick J. Angiolillo, Kristofer Charlton-Ouw, Brian Jefferson, Syed Peeran, Mohannad Bisharat, Luis Ortega-Paz, Ante Harxhi, Simrati Kaul, Evelyne Michaud, Stephanie Juan, Breeana Woods, CV Damaraju, Gregory Fontana, Marc P. Bonaca
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引用次数: 0

Abstract

Introduction

Coronary artery disease (CAD) and peripheral artery disease (PAD) increase the risks of cardiovascular events and death. Digital health technologies are rapidly expanding to improve healthcare quality and access. The Care4Today Connect (C4T CAD-PAD) mobile application is designed to help patients with CAD and/or PAD improve medication adherence, learn about their disease, make lifestyle modifications, and enhance healthcare provider (HCP) connection via an HCP-facing portal.

Hypothesis & Methods

The prospective, single-arm, multicenter, noninterventional iPACE-CVD (innovative Patient compAnion impaCting health outcomEs: a CardioVascular Digital health program) study (ClinicalTrials.gov identifier: NCT06052319) is evaluating engagement and usefulness of the application for patients with CAD and/or PAD in clinical settings. Application access is provided with a code from patients' HCPs. Key features include medication and health experience tracking. The application is available in English and Spanish and for iOS and Android devices. Engagement is defined as the proportion of patients who use the application for ≥ 10 weeks during the 3-month study period. Application use is defined as the number of patients using ≥ 1 application feature(s) each week. Usefulness is determined by the percentage of engaged patients who complete the My Feedback Matters survey with a satisfaction response score of > 2 (on a 5-point scale, where 1 = strongly disagree and 5 = strongly agree) for at least three of the six questions.

Results

A total of 271 participants were enrolled between November 29, 2023, and May 15, 2024. The study concluded on August 15, 2024.

Conclusion

This study will help enhance the application for subsequent studies. Trial Registration: NCT06052319

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评估冠状动脉疾病和外周动脉疾病管理的Care4Today连接数字健康应用程序(iPACE-CVD研究)的参与和有用性研究的基本原理和设计。
冠状动脉疾病(CAD)和外周动脉疾病(PAD)增加心血管事件和死亡的风险。数字医疗技术正在迅速发展,以提高医疗质量和可及性。Care4Today Connect (C4T CAD-PAD)移动应用程序旨在帮助CAD和/或PAD患者改善药物依从性,了解他们的疾病,改变生活方式,并通过面向HCP的门户增强医疗保健提供者(HCP)的联系。假设与方法:这项前瞻性、单组、多中心、非介入性iPACE-CVD(创新的影响健康结果的患者伴侣:心血管数字健康项目)研究(ClinicalTrials.gov识别号:NCT06052319)正在评估临床环境中CAD和/或PAD患者应用的参与和有用性。应用程序访问由患者HCPs提供的代码提供。主要功能包括药物和健康经验跟踪。该应用程序有英语和西班牙语版本,适用于iOS和Android设备。参与定义为在3个月的研究期间使用应用程序≥10周的患者比例。应用使用定义为每周使用≥1个应用特征的患者数量。有用性取决于在6个问题中至少有3个问题完成“我的反馈问题”调查并获得bbbb2(5分制,1 =非常不同意,5 =非常同意)满意度回应得分的参与患者的百分比。结果:在2023年11月29日至2024年5月15日期间,共有271名参与者入组。这项研究于2024年8月15日结束。结论:本研究有助于提高后续研究的应用价值。试验注册:NCT06052319。
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来源期刊
Clinical Cardiology
Clinical Cardiology 医学-心血管系统
CiteScore
5.10
自引率
3.70%
发文量
189
审稿时长
4-8 weeks
期刊介绍: Clinical Cardiology provides a fully Gold Open Access forum for the publication of original clinical research, as well as brief reviews of diagnostic and therapeutic issues in cardiovascular medicine and cardiovascular surgery. The journal includes Clinical Investigations, Reviews, free standing editorials and commentaries, and bonus online-only content. The journal also publishes supplements, Expert Panel Discussions, sponsored clinical Reviews, Trial Designs, and Quality and Outcomes.
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