Heart Failure
Conditions
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.
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.
Interventions
OTHERVirtually administered Cardiac Rehab program
Virtual cardiac rehab program delivered through the CardaHealth platform.
OTHERStandard of Care in person Cardiac Rehab Program
Clinically ordered standard of care cardiac rehab program (in-person).
Sponsors
Independence Blue Cross
CardaHealth
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Intervention model description
Randomized, non-inferiority, Case vs. Control (1 to 1)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| Survey | At completion of cardiac rehabilitation program approximately 36 weeks | Patient satisfaction, physician satisfaction |
Countries
United States
Outcome results
None listed