A Study to Assess the Engagement and Usefulness of Care4Today Digital Platform for Disease Management in Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD) Population

NCT06052319 | Completed

• 1 other identifier: NOPRODPEA0001
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to assess the engagement and usefulness of Care4Today® Connect CAD-PAD digital platform in participants with coronary artery disease or peripheral artery disease (CAD or PAD).

Conditions

Coronary Artery Disease (CAD); Peripheral Artery Disease (PAD)

Keywords

Care4Today, Coronary Artery Disease, Peripheral Artery Disease, CAD, PAD

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who use the Care4Today (C4T) Coronary Artery Disease-Peripheral Artery Disease (CAD-PAD) Application for at Least 10 Weeks During the 3-Month Study Period

  Percentage of participants (of those who onboarded the C4T CAD-PAD app) who use CAD-PAD the application for at least 10 weeks during the 3-month study period will be reported. The weekly app use is defined as using at least one component of the app once a week.

  Up to 3 months

• Percentage of Engaged Participants who Complete End of Study Survey with Satisfaction Response Score of Greater Than or Equal to (>=) 2 for at Least 3 Questions

  Percentage of engaged participants who complete end of study survey with satisfaction response score of \>= 2 for at least 3 questions (out of 6 total questions) will be reported. Satisfaction survey consists of six questions in the end of study - each with 5 possible responses on a likert scale (1-5). The lowest possible response to any question is 1 =disagree and the highest possible response to any question is 5 = agree. Higher response on this scale represents more agreement or satisfaction.

  Up to 3 months

Study Arms (1)

Participants with Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD) or Both

Participants with CAD or PAD or both will be directed to download the Care4Today® (C4T) Connect CAD-PAD mobile application on iPhone or Android device to assess engagement and usefulness of C4T in disease management for 3 months. No study drug and other treatment(s) will be provided as a part of this study. All aspects of treatment and clinical management of participants will continue to be in accordance with local clinical practice and applicable local regulations, and at the discretion of the participating physician.

Device: Care4Today® Connect CAD-PAD Mobile Application

Interventions

Care4Today® Connect CAD-PAD Mobile Application DEVICE

Participants will not receive any drug intervention in this study. Participants will use Care 4Today® Connect CAD-PAD mobile application for 3 months. The study will assess participant engagement and usefulness.

Participants with Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD) or Both

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants ages 40-90 diagnosed with coronary artery disease (CAD) or peripheral artery disease (PAD) or both.

You may qualify if:

• Must have a diagnosis of CAD and or PAD, who are on therapy or about to initiate therapy
• Own an iPhone or Android mobile device
• Have an active email account
• Must sign a participation agreement or informed consent form (ICF) allowing data collection in accordance with local requirements
• Willing to download and use Care4Today (C4T) CAD-PAD application (app)

You may not qualify if:

• Any cardiovascular conditions (for example, recent stroke, high bleeding risk, severe heart failure) or non-cardiovascular condition deemed as poor prognosis by the investigator and which may percent a patient from completing the study
• Unable to read or write the language used for the C4T (English, or Spanish if Spanish version is available)
• Visual or hearing impairment or mental disability that would preclude independent app use
• Patients currently using the C4T app prior to the signing of ICF

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead
• HCA Research Institute, LLC: collaborator

Study Sites (6)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

HCA Florida Memorial Hospital

Jacksonville, Florida, 32216, United States

Location

University of Florida Health Jacksonville

Jacksonville, Florida, 33209, United States

Location

The Kansas City Heart Rhythm Institute

Overland Park, Kansas, 662111, United States

Location

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

Location

Rio Grande Regional Hospital

McAllen, Texas, 78503, United States

Location

Related Publications (1)

• Lakkireddy D, Angiolillo DJ, Charlton-Ouw K, Jefferson B, Peeran S, Bisharat M, Ortega-Paz L, Harxhi A, Kaul S, Michaud E, Juan S, Woods B, Damaraju CV, Fontana G, Bonaca MP. 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). Clin Cardiol. 2024 Dec;47(12):e70039. doi: 10.1002/clc.70039.

  PMID: 39663755 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases

Study Officials

• Janssen Scientific Affairs, LLC Clinical Trial

  Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: November 29, 2023
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)