Clinical trial NCT06052319: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease (CAD)
Peripheral Artery Disease (PAD)
Keywords: Care4Today, Coronary Artery Disease, Peripheral Artery Disease, CAD, PAD
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
Collaborators: name: HCA Research Institute, LLC
First posted: 2023-09-25
Enrollment: 277
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 3 months
measure: 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
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Jacksonville
country: United States
facility: HCA Florida Memorial Hospital
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Overland Park
country: United States
facility: The Kansas City Heart Rhythm Institute
state: Kansas
city: Houston
country: United States
facility: HCA Houston Healthcare Medical Center
state: Texas
city: McAllen
country: United States
facility: Rio Grande Regional Hospital
state: Texas
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: