Heart FailureVIRT-CRNCT05201976
Effect of a Virtually Implemented Cardiac Rehabilitation Program
A study testing Virtually administered Cardiac Rehab program in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Virtually administered Cardiac Rehab program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been prescribed cardiac rehabilitation as part of their standard of care
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19054
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Virtually administered Cardiac Rehab program, Standard of Care in person Cardiac Rehab Program
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtually administered Cardiac Rehab programOther
Virtual cardiac rehab program delivered through the CardaHealth platform.
Standard of Care in person Cardiac Rehab ProgramOther
Clinically ordered standard of care cardiac rehab program (in-person).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Virtual cardiac rehab program delivered through the CardaHealth platform. Receives: Other: Virtually administered Cardiac Rehab program |
| Control | Active comparator | Clinically ordered standard of care cardiac rehab program (in-person). Receives: Other: Standard of Care in person Cardiac Rehab Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2 max (ml/kg/min)
Cardiorespiratory fitness as assessed by maximal VO2
Measured: At baseline visit and at the end of study approximately 40 weeks
Secondary outcomes (8)
Attendance
Subject's adherence to scheduled cardiac rehab sessions.
Measured: 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
Measured: 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.
Measured: 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
Measured: Events will be collected up to 27 months post study enrollment
Survey
Patient satisfaction, physician satisfaction
Measured: At completion of cardiac rehabilitation program approximately 36 weeks
Change in LDL
Ascertained through the electronic health through routinely collected values
Measured: Labs will be collected up to 27 months post study enrollment
Change in HDL
Ascertained through the electronic health through routinely collected values
Measured: Labs will be collected up to 27 months post study enrollment
Change in triglycerides
Ascertained through the electronic health through routinely collected values
Measured: Labs will be collected up to 27 months post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start8 Nov 2021
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, non-inferiority, Case vs. Control (1 to 1)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Independence Blue Cross, CardaHealth
- Responsible party
- Principal investigator, Neel Chokshi, University of Pennsylvania
- Investigators
- Srinath Adusumalli, MD, Principal investigator, University of PennsylvaniaNeel Chokshi, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201976
- Sponsor's protocol ID
- 848902
- Acronym
- VIRT-CR
- Status last verified
- Nov 2024
- First submitted
- 5 Dec 2021
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05201976
- Acronym / sponsor ID
- VIRT-CR / 848902
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Independence Blue Cross, CardaHealth
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized, non-inferiority, Case vs. Control (1 to 1)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Virtually administered Cardiac Rehab programVirtual cardiac rehab program delivered through the CardaHealth platform. |
| Control | Active comparator | Other: Standard of Care in person Cardiac Rehab ProgramClinically ordered standard of care cardiac rehab program (in-person). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have been prescribed cardiac rehabilitation as part of their standard of care
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtually administered Cardiac Rehab programVirtual cardiac rehab program delivered through the CardaHealth platform. | Other | Intervention |
| Standard of Care in person Cardiac Rehab ProgramClinically ordered standard of care cardiac rehab program (in-person). | Other | Control |
Primary outcome
Change in VO2 max (ml/kg/min)
Time frame: At baseline visit and at the end of study approximately 40 weeks
Cardiorespiratory fitness as assessed by maximal VO2
8 secondary outcomes
Attendance
Time frame: Mean number of cardiac rehab sessions completed per patient, over the course of 12 weeks or 36 sessions.
Quality of Life questionnaire
Time frame: Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks
Blood Pressure
Time frame: Start of each cardiac rehab session, over the course of 12 weeks or 36 sessions.
Major adverse cardiovascular events (MACE)
Time frame: Events will be collected up to 27 months post study enrollment
Survey
Time frame: At completion of cardiac rehabilitation program approximately 36 weeks
Change in LDL
Time frame: Labs will be collected up to 27 months post study enrollment
Change in HDL
Time frame: Labs will be collected up to 27 months post study enrollment
Change in triglycerides
Time frame: Labs will be collected up to 27 months post study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinath Adusumalli, MD principal investigator
University of Pennsylvania
Neel Chokshi, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtually administered Cardiac Rehab program in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2 max (ml/kg/min) (time frame: At baseline visit and at the end of study approximately 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.