Virtual Cardiac Rehab Program for Heart Disease

(mTECH-Rehab Trial)

Overseen By Chang Kim, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Severe hypertension, Atrial fibrillation, Depression, others

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

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a virtual cardiac rehab program can improve heart health, quality of life, and mental well-being for individuals who recently experienced a heart attack or underwent heart-related surgery. It compares a new online program, the Corrie Virtual Cardiac Rehabilitation Program, to traditional in-person rehab sessions. Individuals who recently had a heart attack, heart surgery, or a heart stent may be suitable candidates for this study. As an unphased trial, it offers a unique opportunity to explore innovative rehabilitation methods that could enhance recovery and well-being.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Corrie Virtual Cardiac Rehabilitation Program is safe for heart disease patients?

Research has shown that the Corrie Virtual Cardiac Rehabilitation Program is generally safe for patients. While specific safety details are not provided, the program's design is less intense than traditional cardiac rehab, likely resulting in fewer side effects.

The program employs online health tools to aid recovery from heart issues such as heart attacks and surgeries. This approach aims to enhance heart health and quality of life without requiring frequent visits to a rehab center.

Overall, virtual rehab programs like Corrie are considered safe and provide a convenient way to support heart health from home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Corrie Virtual Cardiac Rehabilitation Program because it offers a flexible and accessible alternative to traditional, center-based cardiac rehab. Unlike conventional programs that require patients to visit a rehab center regularly, Corrie leverages digital technology to deliver cardiac rehabilitation virtually, allowing patients to participate from the comfort of their own homes. This approach not only helps reduce barriers such as transportation and scheduling conflicts but also encourages greater patient engagement and adherence to rehabilitation protocols. By integrating virtual support with the option to continue traditional rehab, Corrie aims to enhance patient recovery and improve outcomes for those with heart disease.

What evidence suggests that the Corrie Virtual Cardiac Rehabilitation Program is effective for heart disease?

Studies have shown that the Corrie Virtual Cardiac Rehabilitation Program, available to participants in this trial, can enhance heart health and quality of life. This program uses technology to facilitate cardiac rehab exercises at home. Research indicates that virtual rehab can boost physical abilities, reduce hospital visits, and lower the risk of future heart issues. It also aims to make cardiac rehab more accessible for everyone. These early findings suggest that a virtual approach can match the effectiveness of traditional rehab programs. ^{1 2 3 6 7}

Who Is on the Research Team?

Lena Mathews, MD, MHS

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults who've been hospitalized with heart issues like a heart attack or had procedures like bypass grafting or stenting. It's not for those who don't speak English/Spanish, have severe valve disease, physical disabilities preventing exercise, uncontrolled high blood pressure, certain heart complications, severe depression, sensory impairments that hinder using the program, pregnant women or if they're clinically unstable.

Inclusion Criteria

I was hospitalized for a heart attack or had a procedure to open blocked arteries.

Exclusion Criteria

Pregnancy

I have had heart complications after a heart attack or surgery.

I have an untreated severe heart block.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multi-component virtual/hybrid cardiac rehabilitation program

12 weeks

12 sessions (in-person or off-site)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Corrie Virtual Cardiac Rehabilitation Program

Trial Overview The study tests a virtual cardiac rehab program alongside usual care to see if it betters patients' functional status and overall heart health compared to just standard care. This includes looking at cholesterol levels and mental well-being in people recently diagnosed with cardiovascular diseases.

How Is the Trial Designed?

Group I: Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) Experimental Treatment 1 Intervention

Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.

Group II: Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) Active Control 1 Intervention

Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Apple Inc.

Industry Sponsor

Trials

24

Recruited

1,792,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

A study involving 116 cardiovascular disease patients showed that after three months of a home-based digital cardiac rehabilitation program, participants significantly increased their levels of moderate to vigorous physical activity and reduced sedentary behavior.

The program was safe, with a low dropout rate of 15.5% and only one minor adverse event reported, indicating that digital rehabilitation can effectively support CVD patients during disruptions like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital home-based multidisciplinary cardiac rehabilitation: How to counteract physical inactivity during the COVID-19 pandemic. Pinto, R., Pires, ML., Borges, M., et al.[2022]

A randomized controlled trial will evaluate the effectiveness of a home-based walking exercise program enhanced by digital technologies, involving 100 cardiac patients, to see if it increases their daily steps and physical fitness compared to a non-digital version of the program.

The study aims to address the gap in support for patients after cardiac interventions, potentially improving their physical activity levels and self-efficacy before they enter formal cardiac rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Physical Activity With Self-Tracking and Mobile-Based Coaching for Cardiac Surgery Patients During the Discharge-Rehabilitation Gap: Protocol for a Randomized Controlled Trial. Zhang, C., Soliman-Hamad, M., Robijns, R., et al.[2020]

Cardiac Rehabilitation programs are effective in improving patient outcomes, but the COVID-19 pandemic has created challenges for their implementation.

Tele Cardiac Rehabilitation and remote patient monitoring offer a practical and effective alternative to traditional in-person programs, helping to overcome barriers posed by the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation using telemedicine: the need for tele cardiac rehabilitation. Thamman, R., Janardhanan, R.[2021]

Cardiac telerehabilitation significantly improves long-term cardiopulmonary fitness in patients with coronary artery disease (CAD), showing a mean difference of 1.61 in peak oxygen uptake compared to traditional center-based rehabilitation.

Patients participating in cardiac telerehabilitation also experience an improvement in quality of life, with a mean difference of 0.92, while maintaining a high completion rate of 80% and a low incidence of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longer-Term Effects of Cardiac Telerehabilitation on Patients With Coronary Artery Disease: Systematic Review and Meta-Analysis. Zhong, W., Liu, R., Cheng, H., et al.[2023]

A pilot study involving 15 patients showed that an Internet-based virtual cardiac rehabilitation program (vCRP) is safe and feasible, with no adverse events reported during the 12-week study.

Participants in the vCRP significantly improved key health metrics, including cholesterol levels and exercise capacity, achieving results comparable to traditional cardiac rehabilitation programs, indicating its potential as an effective alternative for patients unable to attend in-person sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of the internet to deliver cardiac rehabilitation at a distance: a pilot study. Zutz, A., Ignaszewski, A., Bates, J., et al.[2022]

A home-based cardiac rehabilitation program enhances access and enrollment for patients, making it easier for them to participate in their recovery.

This program utilizes an evidence-based alternative model of care, which suggests it is grounded in proven methods for improving heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Design and Implementation of a Home-Based Cardiac Rehabilitation Program. Rohrbach, G., Schopfer, DW., Krishnamurthi, N., et al.[2020]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38226511/

Impact of a Mobile Technology Enabled Corrie Cardiac ... Conclusions: The Corrie Hybrid CR program has the potential to improve functional status, cardiovascular health, and CR engagement and advance ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05238103

Impact of a Corrie Cardiac Rehabilitation Program In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9422060/

Building a hybrid virtual cardiac rehabilitation program to ... CR participation improves functionality and quality of life and reduces hospital readmissions, secondary events, and mortality in patients with CVD. Despite the ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.030654

Rationale and Design of the mTECH‐Rehab Randomized ... The Corrie Hybrid CR program has the potential to improve functional status, cardiovascular health, and CR engagement and advance equity in access to cardiac ...

5. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(25)00012-3/fulltext

Effectiveness of home-based cardiac rehabilitation ... This study aims to assess the effects of mHealth HBCR interventions compared with usual care and CBCR in patients with heart disease.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10039430/

Virtual healthcare solutions for cardiac rehabilitation In studies with WAMs as the only virtual CR intervention used (k = 27), 10 (37.0%) reported significant effects on a primary outcome associated with cardiac ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666667722001015

133 hybrid cardiac rehabilitation: early experience from ... A multidisciplinary team launched a 12-week hybrid CR program utilizing in-center and virtual CR sessions via an evidence-based digital health platform.