Coronary Artery Disease (CAD) Clinical Trial
— IPACE-CVDOfficial 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
| Verified date | June 2024 |
| Source | Janssen Scientific Affairs, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Active, not recruiting |
| Enrollment | 277 |
| Est. completion date | July 15, 2024 |
| Est. primary completion date | July 15, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 90 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
| United States | HCA Houston Healthcare Medical Center | Houston | Texas |
| United States | HCA Florida Memorial Hospital | Jacksonville | Florida |
| United States | University of Florida Health Jacksonville | Jacksonville | Florida |
| United States | Rio Grande Regional Hospital | McAllen | Texas |
| United States | The Kansas City Heart Rhythm Institute | Overland Park | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Scientific Affairs, LLC | HCA Research Institute, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |
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