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
- Conditions
- Coronary Artery Disease (CAD)Peripheral Artery Disease (PAD)
- Interventions
- Device: Care4Today® Connect CAD-PAD Mobile Application
- Registration Number
- NCT06052319
- Lead Sponsor
- Janssen Scientific Affairs, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD) or Both Care4Today® Connect CAD-PAD Mobile Application 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.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
University of Florida Health Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Rio Grande Regional Hospital
🇺🇸McAllen, Texas, United States
The Kansas City Heart Rhythm Institute
🇺🇸Overland Park, Kansas, United States
HCA Houston Healthcare Medical Center
🇺🇸Houston, Texas, United States
HCA Florida Memorial Hospital
🇺🇸Jacksonville, Florida, United States