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Multicenter Study
. 2024 Dec;47(12):e70039.
doi: 10.1002/clc.70039.

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)

Dhanunjaya Lakkireddy  1 , Dominick J Angiolillo  2 , Kristofer Charlton-Ouw  3 , Brian Jefferson  4 , Syed Peeran  5 , Mohannad Bisharat  6 , Luis Ortega-Paz  2 , Ante Harxhi  7 , Simrati Kaul  7 , Evelyne Michaud  7 , Stephanie Juan  7 , Breeana Woods  8 , C V Damaraju  7 , Gregory Fontana  9 , Marc P Bonaca  10
Affiliations
Multicenter Study

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)

Dhanunjaya Lakkireddy et al. Clin Cardiol. 2024 Dec.

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.

Keywords: cardiovascular disease; health tracker; medication adherence; mobile health (mHealth); patient education; patient engagement; smartphone application.

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Conflict of interest statement

Dhanunjaya Lakkireddy reports receiving honoraria and/or consulting fees from Abbott, AtriCure, Medtronic, Johnson & Johnson, AltaThera, and Kiniksa Pharma. Dominick J. Angiolillo reports receiving consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi Sankyo, Eli Lilly, Faraday, Haemonetics, Janssen, Merck, Novartis, Novo Nordisk, PhaseBio, PLx Pharma, Pfizer, Sanofi, and Vectura, outside of the submitted work; and declares his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi Sankyo, Eisai, Eli Lilly, Faraday, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, and the Scott R. MacKenzie Foundation. Kristofer Charlton‐Ouw reports consulting for W.L. Gore & Associates and VenoStent; and research funding from Inari Medical, Vesper Medical, BD, Johnson & Johnson, and Piomic Medical. Mohannad Bisharat reports consulting for Abbott, Medtronic, BD, Philips, Inari, and Argon. Ante Harxhi, Simrati Kaul, Evelyne Michaud, Stephanie Juan, and CV Damaraju are employees of Janssen Scientific Affairs, LLC. Breeana Woods is an employee of Johnson & Johnson Technology Solutions. Gregory Fontana reports consulting for Abbott, Medtronic Inc., and JenaValve; being a principal investigator for Abbott and a co‐investigator for Edwards; serving on global scientific advisory boards for Abbott, Medtronic Inc., and JenaValve; and serving on a steering committee for Janssen Scientific Affairs, LLC. Marc P. Bonaca reports being the Executive Director of CPC, a nonprofit academic research organization affiliated with the University of Colorado, that receives or has received research grant/consulting funding between August 2021 and present from Abbott Laboratories, Agios Pharmaceuticals Inc., Alexion Pharma, Alnylam Pharmaceuticals Inc., Amgen, Angionetics Inc., Anthos Therapeutics, ARCA Biopharma Inc., Array BioPharma Inc., AstraZeneca and affiliates, Atentiv LLC, Audentes Therapeutics Inc., Bayer and affiliates, Beth Israel Deaconess Medical Center, Better Therapeutics Inc., Boston Clinical Research Institute, Bristol Myers Squibb, Cambrian Biopharma Inc., Cardiol Therapeutics Inc., CellResearch Corp., Cleerly Inc., Cook Regentec LLC, CSL Behring LLC, Eidos Therapeutics Inc., EP Trading Co. Ltd., EPG Communication Holdings Ltd., Epizon Pharma Inc., Esperion Therapeutics Inc., Everly Well Inc., Exicon Consulting Pvt. Ltd., Faraday Pharmaceuticals Inc., Foresee Pharmaceuticals Co. Ltd., Fortress Biotech Inc., HDL Therapeutics Inc., HeartFlow Inc., Hummingbird Bioscience, Insmed Inc., Ionis Pharmaceuticals, IQVIA Inc., Janssen and affiliates, Kowa Research Institute Inc., Kyushu University, Lexicon Pharmaceuticals Inc., Medimmune Ltd., Medpace, Merck and affiliates, Nectero Medical Inc., Novartis, Pharmaceuticals Corp., Novo Nordisk Inc., Osiris Therapeutics Inc., Pfizer Inc., PhaseBio Pharmaceuticals Inc., PPD Development, LP, Prairie Education and Research Cooperative, Prothena Biosciences Limited, Regeneron Pharmaceuticals Inc., Regio Biosciences Inc., Saint Luke's Hospital of Kansas City, Sanifit Therapeutics S.A., Sanofi‐Aventis Groupe, Silence Therapeutics PLC, Smith & Nephew plc, Stanford Center for Clinical Research, Stealth BioTherapeutics Inc., State of Colorado Cancer, Cardiovascular and Pulmonary Disease (CCPD) Grant, The Brigham & Women's Hospital Inc., The Feinstein Institutes for Medical Research, Thrombosis Research Institute, University of Colorado, University of Pittsburgh, VarmX, Virta Health Corporation, Worldwide Clinical Trials Inc., WraSer, LLC, and Yale Cardiovascular Research Group. The other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Study design of the C4T CAD‐PAD optimization study. App, application; C4T, Care4Today; CAD, coronary artery disease; PAD, peripheral artery disease.
Figure 2
Figure 2
C4T CAD‐PAD screen captures of (A) medication and appointment reminders, (B) health and lifestyle behavior trackers, and (C) easy‐to‐follow trend reports. C4T, Care4Today; CAD, coronary artery disease; PAD, peripheral artery disease.
See this image and copyright information in PMC

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