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).

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.