Mobile Case Management for Heart Rehabilitation

(iCARE Trial)

No longer recruiting at 1 trial location

Overseen By Subban Hassan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Ventricular assist devices

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

Compensation: Varies

Number of Visits: 38

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether heart rehab exercises and education at home, or a combination of home and clinic visits, are as effective as traditional clinic-only rehab. Participants will try different approaches: some will undergo rehab in the clinic (Center-Based Cardiac Rehab), some at home with online tools (Home-Based Cardiac Rehab), and others will use a mix of both. The trial targets individuals who have experienced certain heart problems or surgeries, such as a heart attack or bypass surgery, and who have access to a smartphone or computer with internet. As an unphased trial, it offers participants the chance to contribute to innovative heart rehab solutions that could enhance recovery options for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for cardiac rehabilitation?

Research shows that both center-based and home-based cardiac rehab using mobile health technology are generally safe for people with heart conditions. Studies have found no major difference in safety between home-based and center-based rehab for up to 12 months, indicating that patients can handle both types of rehab well.

For home-based cardiac rehab, a review found that the risk of unwanted effects from treatment is very low, suggesting that this type of rehab is safe for patients to try at home.

Overall, both methods, whether done at home or in a clinic with the help of mobile health tools, have shown to be safe, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how mobile health technology (mHealth) can enhance cardiac rehabilitation, a key recovery process for heart patients. Unlike traditional cardiac rehab that requires frequent center visits, this trial is testing both center-based and home-based rehab options enhanced by an mHealth platform. This platform offers e-Learning modules, a social network for patient interaction, and a personal health record system, making rehab more accessible and engaging. By integrating technology, the trial aims to improve patient participation and outcomes, potentially making heart rehab more effective and convenient.

What evidence suggests that this trial's treatments could be effective for cardiac rehab?

Research has shown that both home-based and center-based cardiac rehab programs are equally effective. In this trial, participants in the Home-Based Cardiac Rehab + mHealth (HOM+) arm will receive mobile health support, which studies have found can improve fitness, lower blood pressure, and boost mental health. Participants in the Conventional Center-Based Cardiac Rehab + mHealth (CON+) arm will also use the mobile health platform, with noted improvements in both physical and mental health. Over a year, no significant difference in effectiveness between home and center-based rehab has been observed, indicating that home rehab with the right tools can be as effective as clinic-based rehab. ^{1 2 4 6 7}

Who Is on the Research Team?

Thomas P Olson, Ph.D., M.S.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for heart patients with conditions like a recent heart attack, angina, or those who've had certain heart surgeries. Participants need to have access to a smartphone or computer with internet and an email address. It's not for those using ventricular assist devices.

Inclusion Criteria

I have a history of heart issues, including heart attack, stable chest pain, heart surgery, or heart failure.

I had heart surgery that requires cardiac rehab.

Have an email address

Exclusion Criteria

I have a ventricular assist device and am referred to cardiac rehab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac rehabilitation through one of three arms: conventional center-based, center-based with mHealth, or home-based with mHealth, for approximately 3 months

12 weeks

36 sessions (in-person for center-based), remote monitoring for home-based

Follow-up

Participants are monitored for safety and effectiveness after treatment, with additional follow-up at 12 months post cardiac rehab entry

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Center-Based Cardiac Rehab
• Home-Based Cardiac Rehab
• mHealth

Trial Overview The study is testing if cardiac rehabilitation done at home (with or without clinic visits) can be as effective as the traditional approach of only attending sessions in a medical center.

How Is the Trial Designed?

Group I: Conventional Center-Based Cardiac Rehab + mHealth (CON+) Active Control 2 Interventions

Participants will be prescribed 36 sessions of center-based CR as noted above. In addition, participants will be provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module will allow patients to communicate via secure network with other patients who are part of their invited network. The Social Network Module also allows for secure two-way interaction with healthcare providers in the event that patients are experiencing signs or symptoms suggestive of worsening condition. This platform also contains a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.

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

Participants will be prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants have direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.

Group III: Home-Based Cardiac Rehab + mHealth (HOM+) Active Control 2 Interventions

Participants will be provided paper copies of educational content at the time of event/discharge. In addition, these participants will be provided access to the same mHealth platform as the CON+ group. Participants in this group will be encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation will be tracked using web/internet analytics.

Center-Based Cardiac Rehab is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Center-Based Cardiac Rehabilitation for:

• Myocardial Infarction
• Angina
• Heart Failure
• Revascularization

Approved in European Union as Centre-Based Cardiac Rehabilitation for:

• Myocardial Infarction
• Angina
• Heart Failure
• Revascularization

Approved in Canada as Clinic-Based Cardiac Rehabilitation for:

• Myocardial Infarction
• Angina
• Heart Failure
• Revascularization

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

A randomized controlled trial involving 525 patients showed that home-based cardiac rehabilitation using the Heart Manual is as effective as traditional center-based programs in improving health outcomes after heart issues, with no significant differences in key measures like blood pressure, cholesterol levels, and psychological status after 12 months.

Although the cost per patient was higher for the home-based program, when factoring in travel costs for center-based rehabilitation, the overall cost differences were not significant, suggesting that home-based rehabilitation can be a viable and cost-effective alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Birmingham Rehabilitation Uptake Maximisation study (BRUM): a randomised controlled trial comparing home-based with centre-based cardiac rehabilitation. Jolly, K., Lip, GY., Taylor, RS., et al.[2021]

Both center-based and home-based cardiac rehabilitation programs significantly improved cardiopulmonary exercise capacity (measured by VO2max and METs) in patients after acute myocardial infarction, with follow-ups at 1 and 6 months showing consistent benefits.

The center-based program uniquely led to a significant improvement in fat-free mass index (FFMI) after 1 month, suggesting that structured, monitored exercise may provide additional benefits in body composition compared to home-based self-exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Obesity Related Index and Exercise Capacity Between Center-Based and Home-Based Cardiac Rehabilitation Programs. Park, HK., Kim, KH., Kim, JH., et al.[2020]

In a study of 251 patients undergoing center-based cardiac rehabilitation (cCR), 50% experienced unplanned medical disruptions, primarily due to glycemic events (71%) and blood pressure abnormalities (12%), highlighting the need for careful monitoring during rehabilitation.

Patients with diabetes mellitus were identified as having a significantly higher risk for these disruptions, suggesting that tailored care strategies, including hybrid models, may be necessary to ensure safety and effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Disruptions During Center-Based Cardiac Rehabilitation: A Necessary Appraisal for the Development of Emerging Remote and Virtual Care Models. Khong, A., Liu, N., Giancaterino, S., et al.[2023]

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]

The Veterans Affairs home-based cardiac rehabilitation (HBCR) program showed significant improvements in various health metrics among 923 veterans, including increased exercise capacity, reduced depression, and better eating habits, with no reported safety issues.

With a completion rate of 62%, the HBCR program was well-received by participants, indicating it is an effective and safe alternative to traditional site-based cardiac rehabilitation, especially for patients with complex health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Cardiac Rehabilitation: EXPERIENCE FROM THE VETERANS AFFAIRS. Drwal, KR., Wakefield, BJ., Forman, DE., et al.[2023]

Home-based cardiac rehabilitation offers a promising alternative to center-based programs, potentially increasing participation among older adults who face financial and logistical barriers.

Further research is needed to evaluate the effectiveness of home-based cardiac rehabilitation, especially for seniors with low socioeconomic status and those living in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Home-Based Cardiac Rehabilitation for Older Adults. Beckie, TM.[2020]

Home-based cardiac rehabilitation (CR) programs, like the Care Assessment Platform (CAP), are as effective as traditional center-based programs and can improve access for patients, especially in remote areas.

The CAP utilizes information and communication technologies (ICT) to enhance patient engagement and monitoring, leading to high usage rates and acceptance among participants, which may improve overall outcomes in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake of a technology-assisted home-care cardiac rehabilitation program. Varnfield, M., Karunanithi, MK., Särelä, A., et al.[2020]

Cardiac rehabilitation (CR) is crucial for improving health outcomes in patients with cardiovascular disease, but participation rates are low in India, highlighting the need for innovative delivery methods.

Home-based cardiac rehabilitation (HBCR) offers a promising alternative to traditional center-based programs, utilizing remote coaching and technology to potentially increase access and participation among eligible patients, especially in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: Appraisal of current evidence and utility of technology aided home-based cardiac rehabilitation. Rathore, S., Kumar, B., Tehrani, S., et al.[2021]

Home-based cardiac rehabilitation can improve patient participation by emphasizing self-management, which requires patients to better understand and manage their own health conditions.

This systematic review and meta-analysis aims to evaluate the effectiveness of self-management programs in home-based cardiac rehabilitation, although specific results and data analysis outcomes are yet to be published.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role and effectiveness of self-management in a home-based cardiac rehabilitation program: A protocol for systematic review and meta analysis. Zhang, S., Liang, C., Zhang, J., et al.[2023]

This study aims to evaluate the safety and efficacy of remote cardiac rehabilitation (RCR) for patients recovering from cardiovascular disease, involving 75 participants across approximately 30 institutions in Japan.

Patients in the RCR group will engage in monitored home-based exercise and receive educational support, with the primary outcome being improvements in peak oxygen uptake or 6-minute walk test results after 2-3 months, suggesting a potential alternative to traditional center-based rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Remote Cardiac Rehabilitation in the Recovery Phase of Cardiovascular Diseases: Protocol for a Multicenter, Nonrandomized, Single-Arm, Interventional Trial. Itoh, H., Amiya, E., Narita, K., et al.[2021]

A systematic review of 25 studies involving 487 individuals revealed that alternative models of cardiac rehabilitation (CR), particularly home-based programs, provide significant physical, psychological, and social benefits to patients with cardiovascular disease.

Patient experiences highlighted key themes such as the benefits of exercise, factors that facilitate participation, and barriers to starting or continuing exercise, emphasizing the need for CR programs that are accessible and accommodating to individual limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits, Facilitators, and Barriers of Alternative Models of Cardiac Rehabilitation: A QUALITATIVE SYSTEMATIC REVIEW. Platz, K., Kools, S., Howie-Esquivel, J.[2023]

Home-based cardiac rehabilitation (CR) is a feasible option for frail older patients, as indicated by a qualitative study involving 8 primary care physiotherapists (PTs) who provided insights on implementing a guideline-centered protocol.

Key factors influencing the success of home-based CR include the feasibility of exercise testing, the motivation of patients, and the importance of interdisciplinary collaboration among healthcare providers to monitor patient risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of home-based cardiac rehabilitation in frail older patients: a clinical perspective. Terbraak, M., Verweij, L., Jepma, P., et al.[2023]

Home-based cardiac rehabilitation (HBCR) is shown to have a very low incidence of adverse events, with only one severe adverse event reported among 808 participants, translating to a rate of 1 per 23,823 patient-hours of exercise.

No deaths or hospitalizations were linked to HBCR, suggesting it is a safe option for patients, including those in high-risk groups, encouraging them to engage in regular physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of home-based cardiac rehabilitation: A systematic review. Stefanakis, M., Batalik, L., Antoniou, V., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37888805/

Home-based versus centre-based cardiac rehabilitation No evidence of a difference was seen between home- and centre-based cardiac rehabilitation in our primary outcomes up to 12 months of follow-up.

2. 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11065672/

Effectiveness of Cardiac Rehabilitation With mHealth Through ... Home-based cardiac rehabilitation is a realistic resource for this purpose, but it requires patients' self-management skills in order to change behaviours.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation The review examines critical factors that influence the success of digital CR, such as digital literacy, concerns about data security, adherence to digital ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001289

Core Components of Cardiac Rehabilitation Programs In this scientific statement, we update the scientific basis of the core components of patient assessment, nutritional counseling, weight management and body ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X23000252

Effectiveness of Cardiac Rehabilitation With mHealth ... This systematic review aims to examine these modalities and identify those that are most effective for improving exercise capacity, quality of life, and ...

7. mhealth.jmir.org mhealth.jmir.org/2024/1/e59098

A Dual-Modality Home-Based Cardiac Rehabilitation Program ... Conclusions: The RecoveryPlus.Health digital HBCR program showed feasibility and efficacy in a group of nationally recruited patients with CVD.