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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtually administered Cardiac Rehab program
Standard of Care in person Cardiac Rehab Program
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention

Control

Arm Description

Virtual cardiac rehab program delivered through the CardaHealth platform.

Clinically ordered standard of care cardiac rehab program (in-person).

Outcomes

Primary Outcome Measures

Change in VO2 max (ml/kg/min)
Cardiorespiratory fitness as assessed by maximal VO2

Secondary Outcome Measures

Attendance
Subject's adherence to scheduled cardiac rehab sessions.
Quality of Life questionnaire
Subject's completion of SF-36
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.
Major adverse cardiovascular events (MACE)
Major cardiovascular events include cardiovascular hospitalizations and mortality
Survey
Patient satisfaction, physician satisfaction
Change in LDL
Ascertained through the electronic health through routinely collected values
Change in HDL
Ascertained through the electronic health through routinely collected values
Change in triglycerides
Ascertained through the electronic health through routinely collected values

Full Information

First Posted
December 5, 2021
Last Updated
July 26, 2023
Sponsor
University of Pennsylvania
Collaborators
Independence Blue Cross, CardaHealth
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1. Study Identification

Unique Protocol Identification Number
NCT05201976
Brief Title
Effect of a Virtually Implemented Cardiac Rehabilitation Program
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Independence Blue Cross, CardaHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, non-inferiority, Case vs. Control (1 to 1)
Masking
Investigator
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Virtual cardiac rehab program delivered through the CardaHealth platform.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Clinically ordered standard of care cardiac rehab program (in-person).
Intervention Type
Other
Intervention Name(s)
Virtually administered Cardiac Rehab program
Intervention Description
Virtual cardiac rehab program delivered through the CardaHealth platform.
Intervention Type
Other
Intervention Name(s)
Standard of Care in person Cardiac Rehab Program
Intervention Description
Clinically ordered standard of care cardiac rehab program (in-person).
Primary Outcome Measure Information:
Title
Change in VO2 max (ml/kg/min)
Description
Cardiorespiratory fitness as assessed by maximal VO2
Time Frame
At baseline visit and at the end of study approximately 40 weeks
Secondary Outcome Measure Information:
Title
Attendance
Description
Subject's adherence to scheduled cardiac rehab sessions.
Time Frame
Mean number of cardiac rehab sessions completed per patient, over the course of 12 weeks or 36 sessions.
Title
Quality of Life questionnaire
Description
Subject's completion of SF-36
Time Frame
Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks
Title
Blood Pressure
Description
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.
Time Frame
Start of each cardiac rehab session, over the course of 12 weeks or 36 sessions.
Title
Major adverse cardiovascular events (MACE)
Description
Major cardiovascular events include cardiovascular hospitalizations and mortality
Time Frame
Events will be collected up to 27 months post study enrollment
Title
Survey
Description
Patient satisfaction, physician satisfaction
Time Frame
At completion of cardiac rehabilitation program approximately 36 weeks
Title
Change in LDL
Description
Ascertained through the electronic health through routinely collected values
Time Frame
Labs will be collected up to 27 months post study enrollment
Title
Change in HDL
Description
Ascertained through the electronic health through routinely collected values
Time Frame
Labs will be collected up to 27 months post study enrollment
Title
Change in triglycerides
Description
Ascertained through the electronic health through routinely collected values
Time Frame
Labs will be collected up to 27 months post study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Clinton
Phone
2156622803
Email
kimberly.clinton@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srinath Adusumalli, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neel Chokshi, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Clinton
Phone
215-662-2803
Email
kimberly.clinton@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Srinath Adusumalli, MD
First Name & Middle Initial & Last Name & Degree
Neel Chokshi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of a Virtually Implemented Cardiac Rehabilitation Program

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