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

259 Participants Needed

Trial Summary

What is the purpose of this trial?

In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to traditional, center-based cardiac rehabilitation.

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 data supports the effectiveness of the Corrie Virtual Cardiac Rehabilitation Program treatment for heart disease?

Research shows that virtual cardiac rehabilitation programs, like the Corrie Virtual Cardiac Rehabilitation Program, can be as effective as traditional in-person programs. Studies have found that these virtual programs help improve heart health by increasing physical activity and managing risk factors, such as cholesterol levels, from the comfort of home. ^{1 2 3 4 5}

Is the Virtual Cardiac Rehab Program safe for humans?

The research articles do not provide specific safety data for the Virtual Cardiac Rehab Program, but they discuss the use of technology in home-based cardiac rehabilitation, which has been implemented successfully to replace or complement traditional programs. ^{3 4 6 7 8}

How is the Corrie Virtual Cardiac Rehabilitation Program different from other treatments for heart disease?

The Corrie Virtual Cardiac Rehabilitation Program is unique because it uses telemedicine to deliver cardiac rehabilitation remotely, making it accessible to patients who may not be able to attend traditional in-person programs due to geographical or other barriers. This approach leverages technologies like the Internet and smartphones to provide flexible and convenient care, which can increase participation and improve outcomes for heart disease patients. ^{2 9 10 11 12}

Research Team

Lena Mathews, MD, MHS

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

Pregnancy

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

I have an untreated severe heart block.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing the Efficacy of a Virtual Assistant in the Remote Cardiac Rehabilitation of Heart Failure and Ischemic Heart Disease Patients: Case-Control Study of Romanian Adult Patients. [2023]

2. Singapore pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation using telemedicine: the need for tele cardiac rehabilitation. [2021]

3. Canada 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. [2020]

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

The Design and Implementation of a Home-Based Cardiac Rehabilitation Program. [2020]

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

Utilization of the internet to deliver cardiac rehabilitation at a distance: a pilot study. [2022]

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

How has technology been used to deliver cardiac rehabilitation during the COVID-19 pandemic? An international cross-sectional survey of healthcare professionals conducted by the BACPR. [2021]

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

Identifying participation rates at outpatient cardiac rehabilitation programs in Victoria, Australia. [2022]

8. Portugal pubmed.ncbi.nlm.nih.gov

Digital home-based multidisciplinary cardiac rehabilitation: How to counteract physical inactivity during the COVID-19 pandemic. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Longer-Term Effects of Cardiac Telerehabilitation on Patients With Coronary Artery Disease: Systematic Review and Meta-Analysis. [2023]

10. England pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

Use of cardiac telerehabilitation during COVID-19 pandemic in Belgium. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The development of an internet-based outpatient cardiac rehabilitation intervention: a Delphi study. [2022]