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

NCT ID: NCT06052319

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

277 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-29

Study Completion Date

2024-08-13

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Care4Today® Connect CAD-PAD Mobile Application

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HCA Research Institute, LLC

UNKNOWN

Sponsor Role collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Scientific Affairs, LLC

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

HCA Florida Memorial Hospital

Jacksonville, Florida, United States

Site Status

University of Florida Health Jacksonville

Jacksonville, Florida, United States

Site Status

The Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Site Status

HCA Houston Healthcare Medical Center

Houston, Texas, United States

Site Status

Rio Grande Regional Hospital

McAllen, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39663755 (View on PubMed)

Other Identifiers

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NOPRODPEA0001

Identifier Type: OTHER

Identifier Source: secondary_id

NOPRODPEA0001

Identifier Type: -

Identifier Source: org_study_id

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