Virtual vs Center-Based Cardiac Rehab for Cardiovascular Disease

(VWCR Trial)

Overseen By Moen R Lainey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: High risk cardiac, Inotropic support, Mechanical support, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

2881 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Virtual World-Based Cardiac Rehabilitation (VWCR) for cardiovascular disease?

Research shows that virtual cardiac rehabilitation, which includes using mobile apps and wearable activity monitors, can improve quality of life and increase physical activity. These virtual programs can also help more people stick with their rehabilitation, especially those who can't easily access center-based programs. ^{1 2 3 4 5}

Is virtual cardiac rehabilitation safe for humans?

Research on virtual cardiac rehabilitation programs, which use technologies like mobile apps and web-based solutions, suggests they are generally safe for humans. These programs have been accepted by patients and have shown potential positive effects on clinical outcomes, similar to traditional center-based cardiac rehabilitation. ^{3 4 5 6 7}

How does the Virtual World-Based Cardiac Rehabilitation treatment differ from other cardiac rehabilitation treatments?

The Virtual World-Based Cardiac Rehabilitation (VWCR) treatment is unique because it uses a virtual world platform, like Second Life, to deliver cardiac rehabilitation remotely, making it more accessible to people who face barriers to attending traditional in-person programs. ^{4 7 8 9 10}

What is the purpose of this trial?

This trial tests a home-based virtual rehab program for heart patients. It aims to make it easier for them to follow their rehab by providing online education, health tracking, social support, and video calls with healthcare professionals. The goal is to see if this virtual program is as effective as traditional in-person rehab.

Research Team

LaPrincess C Brewer, MD, MPH

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 18 who need cardiac rehab based on specific health conditions like recent heart attacks, surgeries, or stable heart issues. They must be able to use the internet and have an email address. It's not for high-risk patients with severe heart problems, those needing constant support, non-English speakers, or pregnant women.

Inclusion Criteria

Basic Internet navigation skills

I have an active email address.

I qualify for cardiac rehab due to a recent heart issue or surgery.

Exclusion Criteria

Visual/hearing impairment or mental disability that would preclude independent use of the VW platform

High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification (e.g., sudden cardiac arrest survivor)

Pregnant (due to associated hormonal and weight changes)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week cardiac rehabilitation program, either virtually or in-person, including patient education, self-monitoring, social support, and weekly telehealth visits

12 weeks

36 sessions (weekly telehealth visits)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months post-randomization

6 months

Treatment Details

Interventions

• Center-Based Cardiac Rehabilitation (CBCR)
• Virtual World-Based Cardiac Rehabilitation (VWCR)

Trial Overview The study compares a new Virtual World-Based Cardiac Rehabilitation (VWCR) program called 'Destination Cardiac Rehab' with traditional center-based rehabilitation to see if it's just as effective and whether people stick with it.

Participant Groups

Group I: Virtual World-Based Cardiac Rehab (VWCR) Experimental Treatment 1 Intervention

Telehealth delivery of cardiac rehabilitation via Second Life virtual world platform. 12-week, home-based program.

Group II: Center-Based Cardiac Rehab (CBCR) Active Control 1 Intervention

Standard of care for participants' center-based cardiac rehabilitation program. Traditional 12-week, in-person program.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Findings from Research

A digital health intervention (DHI) combined with remote cardiac rehabilitation (CR) significantly improved access to CR, with 90% of participants completing the program out of 258 who consented from 1,643 referrals.

Participants in the DHI showed notable improvements in their 6-minute walk test distance and reductions in low-density lipoprotein cholesterol, along with a decrease in smoking rates, all without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. Harzand, A., Alrohaibani, A., Idris, MY., et al.[2023]

Mobile technologies, including wearable activity monitors and virtual rehabilitation solutions, have the potential to enhance adherence to cardiac rehabilitation, which is crucial for improving quality of life and reducing hospitalizations.

The review of 113 studies showed mixed results regarding the efficacy of virtual cardiac rehabilitation compared to traditional methods, but highlighted the importance of user adherence and long-term engagement as key benefits of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions for cardiac rehabilitation: a literature review. Lee, KCS., Breznen, B., Ukhova, A., et al.[2023]

Cardiac rehabilitation (CR) programs significantly reduce future cardiac events and mortality, but only about 10% of eligible patients participate due to geographical barriers.

The development of virtual CR programs, utilizing technologies like the Internet and smartphones, shows promise in improving patient access and has demonstrated positive effects on clinical outcomes in small randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. Lear, SA.[2019]

Using the Active+me platform alongside standard cardiac rehabilitation (CR) led to a significant increase in patient activation measures (PAM), indicating improved patient confidence and knowledge in managing their health, particularly among high-risk patients.

Participants also experienced reductions in resting blood pressure and waist circumference, along with a notable increase in self-reported physical activity levels, suggesting that Active+me effectively supports lifestyle changes in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in patient activation following cardiac rehabilitation using the Active+me digital healthcare platform during the COVID-19 pandemic: a cohort evaluation. Frith, G., Carver, K., Curry, S., et al.[2021]

The virtual world-based cardiac rehabilitation program, Destination Rehab, was found to be feasible and highly acceptable among adult cardiac patients, with 93% attending at least one session and 71% attending 75% or more of the sessions.

While the program showed promising trends in improving cardiovascular health behaviors and biometrics, these changes were not statistically significant, indicating further research is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Community-Informed Virtual World-Based Cardiac Rehabilitation Program as an Extension of Center-Based Cardiac Rehabilitation: MIXED-METHODS ANALYSIS OF A MULTICENTER PILOT STUDY. Brewer, LC., Abraham, H., Kaihoi, B., et al.[2023]

In a study of 187 cardiac rehabilitation patients, both hybrid and virtual rehabilitation methods showed similar improvements in the 6-minute walk test compared to traditional in-person rehabilitation, indicating that these alternative delivery methods are effective.

While hybrid and virtual rehabilitation improved blood pressure control and anxiety levels similarly to in-person sessions, virtual patients showed less improvement in depression symptoms, suggesting that while these methods are effective, they may require additional support for mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes and Qualitative Perceptions of In-person, Hybrid, and Virtual Cardiac Rehabilitation. Ganeshan, S., Jackson, H., Grandis, DJ., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled clinical trial of cardiac telerehabilitation with a prolonged mobile care monitoring strategy after an acute coronary syndrome. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions for cardiac rehabilitation: a literature review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy and Adherence Rates of a Novel Community-Informed Virtual World-Based Cardiac Rehabilitation Program: Protocol for the Destination Cardiac Rehab Randomized Controlled Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Changes in patient activation following cardiac rehabilitation using the Active+me digital healthcare platform during the COVID-19 pandemic: a cohort evaluation. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A Community-Informed Virtual World-Based Cardiac Rehabilitation Program as an Extension of Center-Based Cardiac Rehabilitation: MIXED-METHODS ANALYSIS OF A MULTICENTER PILOT STUDY. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Patient-perceived acceptability of a virtual world-based cardiac rehabilitation program. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Review of the Design and Implementation of a Hybrid Cardiac Rehabilitation Program: AN EXPANDING OPPORTUNITY FOR OPTIMIZING CARDIOVASCULAR CARE. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes and Qualitative Perceptions of In-person, Hybrid, and Virtual Cardiac Rehabilitation. [2023]