Effect of a Virtually Implemented Cardiac Rehabilitation Program

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Virtually administered Cardiac Rehab program
* Other: Standard of Care in person Cardiac Rehab Program


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, non-inferiority, Case vs. Control (1 to 1)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Virtual cardiac rehab program delivered through the CardaHealth platform. | Other: Virtually administered Cardiac Rehab program<br>* Virtual cardiac rehab program delivered through the CardaHealth platform.<br>|
| Active Comparator: Control<br>Clinically ordered standard of care cardiac rehab program (in-person). | Other: Standard of Care in person Cardiac Rehab Program<br>* Clinically ordered standard of care cardiac rehab program (in-person).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VO2 max (ml/kg/min) | Cardiorespiratory fitness as assessed by maximal VO2 | At baseline visit and at the end of study approximately 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance | Subject's adherence to scheduled cardiac rehab sessions. | Mean number of cardiac rehab sessions completed per patient, over the course of 12 weeks or 36 sessions. | 
| Quality of Life questionnaire | Subject's completion of SF-36 | Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks | 
| Blood Pressure | 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. | Start of each cardiac rehab session, over the course of 12 weeks or 36 sessions. | 
| Major adverse cardiovascular events (MACE) | Major cardiovascular events include cardiovascular hospitalizations and mortality | Events will be collected up to 27 months post study enrollment | 
| Survey | Patient satisfaction, physician satisfaction | At completion of cardiac rehabilitation program approximately 36 weeks | 
| Change in LDL | Ascertained through the electronic health through routinely collected values | Labs will be collected up to 27 months post study enrollment | 
| Change in HDL | Ascertained through the electronic health through routinely collected values | Labs will be collected up to 27 months post study enrollment | 
| Change in triglycerides | Ascertained through the electronic health through routinely collected values | Labs will be collected up to 27 months post study enrollment |