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| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODPEA0001 | Other Identifier | Janssen Scientific Affairs, LLC |
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| Name | Class |
|---|---|
| HCA Research Institute, LLC | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care4Today® Connect CAD-PAD Mobile Application | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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The study population will include participants ages 40-90 diagnosed with coronary artery disease (CAD) or peripheral artery disease (PAD) or both.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| HCA Florida Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39663755 | Derived | 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. |
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| Jacksonville |
| Florida |
| 32216 |
| United States |
| University of Florida Health Jacksonville | Jacksonville | Florida | 33209 | United States |
| The Kansas City Heart Rhythm Institute | Overland Park | Kansas | 662111 | United States |
| HCA Houston Healthcare Medical Center | Houston | Texas | 77004 | United States |
| Rio Grande Regional Hospital | McAllen | Texas | 78503 | United States |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |
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