VIRT-CR: Effect of a Virtually Implemented Cardiac Rehabilitation Program
Study Details
Study Description
Brief Summary
A clinical trial investigating the effects of a virtually implemented home-based cardiac rehab program with real-time, video based exercise supervision and vitals monitoring.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study will use a randomized, controlled trial design to test the effectiveness of a virtually implemented cardiac rehabilitation (CR) program with real-time, video based supervised exercise and vitals monitoring as compared to traditional center based rehab in patients with a clinical indication for cardiac rehab. The primary outcome of effectiveness will be change in cardiorespiratory fitness as assessed by maximal VO2 achieved at the start of CR and on upon completion of CR.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention Virtual cardiac rehab program delivered through the CardaHealth platform. |
Other: Virtually administered Cardiac Rehab program
Virtual cardiac rehab program delivered through the CardaHealth platform.
|
| Active Comparator: Control Clinically ordered standard of care cardiac rehab program (in-person). |
Other: Standard of Care in person Cardiac Rehab Program
Clinically ordered standard of care cardiac rehab program (in-person).
|
Outcome Measures
Primary Outcome Measures
- Change in VO2 max (ml/kg/min) [At baseline visit and at the end of study approximately 40 weeks]
Cardiorespiratory fitness as assessed by maximal VO2
Secondary Outcome Measures
- Attendance [Mean number of cardiac rehab sessions completed per patient, over the course of 12 weeks or 36 sessions.]
Subject's adherence to scheduled cardiac rehab sessions.
- Quality of Life questionnaire [Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks]
Subject's completion of SF-36
- Blood Pressure [Start of each cardiac rehab session, over the course of 12 weeks or 36 sessions.]
Change in systolic and diastolic blood pressure over the duration of the study. BP will be self-assessed by the subjects at the start of each session.
- Major adverse cardiovascular events (MACE) [Events will be collected up to 27 months post study enrollment]
Major cardiovascular events include cardiovascular hospitalizations and mortality
- Survey [At completion of cardiac rehabilitation program approximately 36 weeks]
Patient satisfaction, physician satisfaction
- Change in LDL [Labs will be collected up to 27 months post study enrollment]
Ascertained through the electronic health through routinely collected values
- Change in HDL [Labs will be collected up to 27 months post study enrollment]
Ascertained through the electronic health through routinely collected values
- Change in triglycerides [Labs will be collected up to 27 months post study enrollment]
Ascertained through the electronic health through routinely collected values
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients who have been prescribed cardiac rehabilitation as part of their standard of care
Exclusion Criteria:
-
Patients with significant exercise limitations other than cardiovascular disease
-
Patients who are unable to exercise in home
-
Patients with active cancer treatment
-
Patients who do not have an email address or a cell phone
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19054 |
Sponsors and Collaborators
- University of Pennsylvania
- Independence Blue Cross
- CardaHealth
Investigators
- Principal Investigator: Srinath Adusumalli, MD, University of Pennsylvania
- Principal Investigator: Neel Chokshi, MD, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 848902