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 (IPACE-CVD)

April 23, 2024 updated by: Janssen Scientific Affairs, LLC

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of COlorado Anschutz Medical Campus
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • HCA Florida Memorial Hospital
      • Jacksonville, Florida, United States, 33209
        • Recruiting
        • University of Florida Health Jacksonville
    • Kansas
      • Overland Park, Kansas, United States, 662111
        • Recruiting
        • The Kansas City Heart Rhythm Institute
    • Texas
      • Houston, Texas, United States, 77004
        • Recruiting
        • HCA Houston Healthcare Medical Center
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Rio Grande Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
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
Time Frame: 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.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Scientific Affairs, LLC

Collaborators

HCA Research Institute, LLC

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOPRODPEA0001 (Other Identifier: Janssen Scientific Affairs, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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