IPACE-CVD: 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

Janssen Scientific Affairs, LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
HCA Research Institute, LLC (Other)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Care4Today® Connect CAD-PAD Mobile Application

Study Design

Study Type:
Anticipated Enrollment :
300 participants
Observational Model:
Time Perspective:
Official Title:
A Pilot Study to Assess the Engagement and Usefulness of Care4Today Digital Platform for Disease Management in Coronary Artery Disease/ Peripheral Artery Disease (CAD/PAD) Population
Anticipated Study Start Date :
Sep 18, 2023
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. 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 [Up to 3 months]

    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.

  2. 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 [Up to 3 months]

    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.

Eligibility Criteria


Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • 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)

Exclusion Criteria:
  • 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

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Janssen Scientific Affairs, LLC
  • HCA Research Institute, LLC


  • Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
First Posted:
Sep 25, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Janssen Scientific Affairs, LLC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2023