Effect of a Virtually Implemented Cardiac Rehabilitation Program

Heart Failure Clinical Trial

— VIRT-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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05201976
• Other study ID #: 848902
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Virtually administered Cardiac Rehab program
Virtual cardiac rehab program delivered through the CardaHealth platform.
• Standard of Care in person Cardiac Rehab Program
Clinically ordered standard of care cardiac rehab program (in-person).

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	CardaHealth, Independence Blue Cross

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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.
Secondary	Major adverse cardiovascular events (MACE)	Major cardiovascular events include cardiovascular hospitalizations and mortality	Events will be collected up to 27 months post study enrollment
Secondary	Survey	Patient satisfaction, physician satisfaction	At completion of cardiac rehabilitation program approximately 36 weeks
Secondary	Change in LDL	Ascertained through the electronic health through routinely collected values	Labs will be collected up to 27 months post study enrollment
Secondary	Change in HDL	Ascertained through the electronic health through routinely collected values	Labs will be collected up to 27 months post study enrollment
Secondary	Change in triglycerides	Ascertained through the electronic health through routinely collected values	Labs will be collected up to 27 months post study enrollment