In-Person vs Telehealth Cardiac Rehab for Heart Disease

Recruiting at 3 trial locations

Overseen By Alisa Boyd, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Unstable arrhythmias, Hospice, others

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

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

516 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.

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 seems focused on comparing in-person and telehealth cardiac rehab, so you may not need to change your medications, but it's best to ask the trial staff for confirmation.

Is cardiac rehabilitation safe for humans?

Research indicates that both in-person and virtual cardiac rehabilitation programs are generally safe for humans, with studies showing no adverse events in participants of virtual programs. ^{1 2 3 4 5}

How does in-person vs telehealth cardiac rehabilitation differ from other treatments for heart disease?

In-person and telehealth cardiac rehabilitation are unique because they focus on structured exercise and lifestyle changes to improve heart health, rather than using surgical or drug interventions. This approach can be more accessible and less invasive, offering flexibility for patients to participate from home or in a facility, which is different from treatments like the MitraClip procedure that involve surgical repair of heart valves. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment In-person vs Telehealth Cardiac Rehab for Heart Disease?

Research shows that both in-person and telehealth cardiac rehabilitation can improve physical activity, clinical outcomes, and psychosocial measures for heart disease patients. Telehealth approaches, which use internet and communication technologies, have been found to be as effective as traditional in-person programs, making them a viable option for those who cannot attend in-person sessions. ^{1 3 11 12 13}

Who Is on the Research Team?

Alexis Beatty, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need cardiac rehabilitation and have had a recent heart-related event or procedure, like a heart attack or surgery. They must be able to attend rehab sessions in-person or via telehealth and communicate in English or Spanish. People with unstable arrhythmias making exercise risky, those deemed unsafe by the investigator, hospice patients, or anyone unable to consent cannot join.

Inclusion Criteria

I was diagnosed with a serious heart condition in the last year.

I am open to either in-person or remote cardiac rehab.

I can communicate in English or Spanish.

Exclusion Criteria

I am unable to give my own consent for medical procedures.

I have heart rhythm problems that make exercise unsafe without monitoring.

I am not enrolled in hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12-week cardiac rehabilitation, either in-person or via telehealth, including exercise training, health education, and counseling

12 weeks

36 sessions (in-person) or 12 sessions (telehealth)

Follow-up

Participants are monitored for changes in health outcomes such as blood pressure and mental health scores

24 months

What Are the Treatments Tested in This Trial?

Interventions

• In-person cardiac rehabilitation
• Telehealth cardiac rehabilitation

Trial Overview The study compares two ways of doing cardiac rehab: traditional in-person visits versus remote participation through telehealth. It aims to see if one method is more effective than the other and whether certain patients might benefit more from either approach.

How Is the Trial Designed?

Group I: In-person cardiac rehabilitation Active Control 1 Intervention

Participants will participate in 12-week in-person cardiac rehabilitation as delivered at the site where they are enrolled. The typical course is 36 sessions of group exercise, health education, and counseling over 12 weeks.

Group II: Telehealth cardiac rehabilitation Active Control 1 Intervention

Participants will participate in 12-week telehealth cardiac rehabilitation. The program will follow the same core components as in-person cardiac rehabilitation, but in-person supervised exercise will not be required. The core element of telehealth cardiac rehabilitation is 12 weekly individual telehealth sessions between the patient and cardiac rehabilitation provider.

In-person cardiac rehabilitation is already approved in United States, Canada, European Union, Japan for the following indications:

Approved in United States as In-person Cardiac Rehabilitation for:

• Heart Attack
• Heart Failure
• Heart Valve Disease
• Stable Angina
• Coronary Artery Disease
• Peripheral Artery Disease
• Heart Transplant

Approved in Canada as In-person Cardiac Rehabilitation for:

• Heart Attack
• Heart Failure
• Heart Valve Disease
• Stable Angina
• Coronary Artery Disease
• Peripheral Artery Disease
• Heart Transplant

Approved in European Union as In-person Cardiac Rehabilitation for:

• Heart Attack
• Heart Failure
• Heart Valve Disease
• Stable Angina
• Coronary Artery Disease
• Peripheral Artery Disease
• Heart Transplant

Approved in Japan as In-person Cardiac Rehabilitation for:

• Heart Attack
• Heart Failure
• Heart Valve Disease
• Stable Angina
• Coronary Artery Disease
• Peripheral Artery Disease
• Heart Transplant

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The Telerehab III study aims to evaluate the long-term effectiveness of a comprehensive internet-based telerehabilitation program combined with standard cardiac rehabilitation in 140 patients with coronary artery disease or chronic heart failure, with a follow-up period of at least 6 months.

The primary focus is on improving peak oxygen consumption (VO2 peak), while secondary outcomes include physical activity levels, cardiovascular risk management, quality of life, and rehospitalization rates, potentially enhancing current cardiac rehabilitation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehab III: a multi-center randomized, controlled trial investigating the long-term effectiveness of a comprehensive cardiac telerehabilitation program--rationale and study design. Frederix, I., Hansen, D., Coninx, K., et al.[2018]

Internet-based cardiac rehabilitation (CR) has been shown to improve compliance and physical activity outcomes in patients with heart disease, based on a review of nine studies involving 830 patients.

The studies indicated positive clinical and psychosocial outcomes, with no negative effects reported, suggesting that telemedicine could be a viable option for expanding access to CR, although none of the interventions have yet been implemented as a clinical service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient focused Internet-based approaches to cardiovascular rehabilitation--a systematic review. Munro, J., Angus, N., Leslie, SJ.[2018]

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]

Telehealth exercise-based cardiac rehabilitation (exCR) significantly improves physical activity levels and exercise adherence compared to usual care, based on a meta-analysis of 11 trials involving 1189 patients with coronary heart disease.

Telehealth exCR is at least as effective as traditional centre-based exCR in enhancing cardiovascular risk factors like diastolic blood pressure and LDL cholesterol, making it a valuable alternative for patients unable to attend in-person sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth exercise-based cardiac rehabilitation: a systematic review and meta-analysis. Rawstorn, JC., Gant, N., Direito, A., et al.[2022]

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]

Remote-delivered cardiac rehabilitation (CR) during the COVID-19 pandemic provided equivalent health-related quality of life (HRQL) outcomes compared to in-person CR, with notable improvements in mental health for remote participants.

Participants in remote CR experienced shorter wait times for starting the program, but there was a significant decrease in participation from ethnic minorities, highlighting a need for strategies to improve access for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote-delivered cardiac rehabilitation during COVID-19: a prospective cohort comparison of health-related quality of life outcomes and patient experiences. Candelaria, D., Kirkness, A., Farrell, M., et al.[2022]

A study involving 753 women showed that technology-enabled home-based cardiac rehabilitation (HBCR) produced similar clinical outcomes compared to traditional center-based cardiac rehabilitation (CBCR).

The findings indicate that HBCR is a viable alternative for women, including those with multiple health conditions, suggesting it can effectively support their recovery after cardiac events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology enabled home-based cardiac rehabilitation among women with cardiovascular disease: A longitudinal cohort study. Najem, M., Duggan, M., Gambatese, R., 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]

An 85-year-old male patient with severe multivalvular heart disease successfully avoided rehospitalization after receiving a MitraClip implantation, which significantly reduced his mitral regurgitation from moderate-severe to mild.

The combination of MitraClip implantation and ongoing multidisciplinary cardiac rehabilitation led to a stable condition for the patient over a one-year follow-up, demonstrating a potential effective treatment strategy for older patients with complex heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of MitraClip and continued multidisciplinary cardiac rehabilitation in preventing readmission of an older heart failure patient with severe multivalvular disease: A case report. Ishihara, K., Izawa, KP., Morikawa, T., et al.[2023]

A 55-year-old male patient with severe mitral regurgitation and chronic heart failure underwent successful transcatheter mitral valve repair (TMVR) using a MitraClip, which significantly reduced his mitral regurgitation from severe to trivial.

Post-procedure, the patient's symptoms improved dramatically, allowing him to move from NYHA class IIm to class I, and he was discharged without any complications, highlighting TMVR as a safe and effective treatment option for high-risk patients with multiple comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve repair with a mitraclip for severe mitral regurgitation in a patient on hemodialysis. Sato, H., Sakurada, T., Kojima, S., et al.[2022]

The MitraClip device, used for transcatheter edge-to-edge repair of secondary mitral regurgitation (MR), has shown conflicting results in two major trials (MITRA-FR and COAPT), highlighting the complexity of patient selection for this treatment.

Differences in patient characteristics and clinical factors between the COAPT and MITRA-FR trials may explain the varying outcomes, suggesting that careful evaluation of these factors is crucial for optimizing treatment success in heart failure patients with secondary MR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MitraClip for secondary mitral regurgitation: Patient selection. Zalawadiya, SK., Gonzales, HM., Goel, K., et al.[2022]

The MitraClip procedure shows promising preliminary results for treating mitral regurgitation, indicating potential clinical benefits for selected patients, although final data from larger trials are still needed.

A multidisciplinary consensus among various heart specialists is crucial for making informed treatment decisions for mitral regurgitation, as there are currently no evidence-based guidelines available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter treatment of chronic mitral regurgitation with the MitraClip system: an Italian consensus statement. Maisano, F., Alamanni, F., Alfieri, O., et al.[2014]

The MitraClip device has been evaluated in two major trials for treating secondary mitral regurgitation in patients with systolic heart failure, but the MITRA-FR trial showed neutral results while the COAPT trial demonstrated significant efficacy, highlighting a major discrepancy in outcomes.

Understanding the differences in trial design and patient populations between MITRA-FR and COAPT is crucial for determining the appropriate clinical application of the MitraClip procedure in treating secondary mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MITRA-FR vs. COAPT: lessons from two trials with diametrically opposed results. Pibarot, P., Delgado, V., Bax, JJ.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Telerehab III: a multi-center randomized, controlled trial investigating the long-term effectiveness of a comprehensive cardiac telerehabilitation program--rationale and study design. [2018]

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

Patient focused Internet-based approaches to cardiovascular rehabilitation--a systematic review. [2018]

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

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

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

Telehealth exercise-based cardiac rehabilitation: a systematic review and meta-analysis. [2022]

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

Remote-delivered cardiac rehabilitation during COVID-19: a prospective cohort comparison of health-related quality of life outcomes and patient experiences. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Technology enabled home-based cardiac rehabilitation among women with cardiovascular disease: A longitudinal cohort study. [2023]

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

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

9. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of MitraClip and continued multidisciplinary cardiac rehabilitation in preventing readmission of an older heart failure patient with severe multivalvular disease: A case report. [2023]

10. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve repair with a mitraclip for severe mitral regurgitation in a patient on hemodialysis. [2022]

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

MitraClip for secondary mitral regurgitation: Patient selection. [2022]

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

Transcatheter treatment of chronic mitral regurgitation with the MitraClip system: an Italian consensus statement. [2014]

13. England pubmed.ncbi.nlm.nih.gov

MITRA-FR vs. COAPT: lessons from two trials with diametrically opposed results. [2020]