Coronary Artery Disease (CAD)IPACE-CVDNCT06052319
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
An observational study of Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD), run by Janssen Scientific Affairs, LLC at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Coronary Artery Disease (CAD), Peripheral Artery Disease (PAD)
- What is being tested?
- Care4Today® Connect CAD-PAD Mobile Application
- Type of treatment
- Medical device
- How many people
- 277 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Nov 2023to 13 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include participants ages 40-90 diagnosed with coronary artery disease (CAD) or peripheral artery disease (PAD) or both.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
HCA Florida Memorial Hospital
Jacksonville, Florida, 32216
University of Florida Health Jacksonville
Jacksonville, Florida, 33209
Rio Grande Regional Hospital
McAllen, Texas, 78503
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, 662111
About this study
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
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).
- Being tested
- Care4Today® Connect CAD-PAD Mobile Application
- Keywords
- Care4Today, Coronary Artery Disease, Peripheral Artery Disease, CAD, PAD
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care4Today® Connect CAD-PAD Mobile ApplicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Care4Today® Connect CAD-PAD Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start29 Nov 2023
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HCA Research Institute, LLC
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052319
- Sponsor's protocol ID
- NOPRODPEA0001
- Other IDs
- NOPRODPEA0001
- Acronym
- IPACE-CVD
- Status last verified
- Apr 2025
- First submitted
- 18 Sep 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39663755
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06052319
- Acronym / sponsor ID
- IPACE-CVD / NOPRODPEA0001
- Keywords
- Care4Today, Coronary Artery Disease, Peripheral Artery Disease, CAD, PAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Collaborators
- HCA Research Institute, LLC
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD) or Both | – | Device: Care4Today® Connect CAD-PAD Mobile ApplicationParticipants 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include participants ages 40-90 diagnosed with coronary artery disease (CAD) or peripheral artery disease (PAD) or both.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care4Today® Connect CAD-PAD Mobile ApplicationParticipants 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. | Device | Participants with Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD) or Both |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 39663755Lakkireddy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD), run by Janssen Scientific Affairs, LLC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06052319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.