Effect of a Virtually Implemented Cardiac Rehabilitation Program (VIRT-CR)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Virtually administered Cardiac Rehab program; Other: Standard of Care in person Cardiac Rehab Program

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19054
      • UNIVERSITY of PENNSYLVANIA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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).

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Independence Blue Cross; CardaHealth
• Investigators: Principal Investigator: Srinath Adusumalli, MD, UNIVERSITY of PENNSYLVANIA; Principal Investigator: Neel Chokshi, MD, UNIVERSITY of PENNSYLVANIA

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 848902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No