Smartphone-Based Cardiac Rehab for Cardiovascular Disease

Overseen By Amit Shah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Unstable angina, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone-based program can enhance cardiac rehab for individuals with heart and lung conditions. Participants will use an app and receive regular phone calls to aid their recovery. The trial compares this new method, which includes Movn Pulmonary Rehabilitation and MULTIFIT Cardiac Rehabilitation, to standard rehab care. It targets individuals with heart issues such as a recent heart attack, stable angina (chest pain), or those who have undergone certain heart surgeries. As an unphased trial, this study provides patients the opportunity to contribute to innovative rehabilitation methods that could improve recovery for many.

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 prior data suggests that this smartphone-based cardiac rehab program is safe?

Research shows that using a smartphone for cardiac rehabilitation is generally safe. Studies find that patients are satisfied and experience few negative effects. Completion rates for these programs match those of traditional rehab, indicating they are well-received.

For the MULTIFIT Cardiac Rehabilitation, research indicates it is a safe and effective alternative to in-person rehab, reducing the risk of hospital readmission. Long-term studies show few serious negative effects, making it a dependable option for many.

Both the Movn and MULTIFIT programs offer safe and effective choices for those considering remote rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the smartphone-based cardiac rehab programs like Movn because they offer a unique and accessible approach to rehabilitation for individuals with cardiovascular and pulmonary conditions. Unlike traditional cardiac rehabilitation, which typically requires patients to visit a facility, Movn allows patients to participate from the comfort of their homes, making it more convenient and potentially increasing adherence. This method leverages technology to provide structured, ongoing support and personalized feedback, which could enhance recovery outcomes for those with coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD). By transforming how rehab is delivered, Movn aims to improve the accessibility and effectiveness of cardiac care.

What evidence suggests that this trial's treatments could be effective for cardiovascular disease?

Research has shown that mobile technology in heart health programs can improve heart function, exercise ability, and quality of life for individuals with heart problems. In this trial, participants will join different programs. The Movn Pulmonary Rehabilitation program, one study arm, lowers heart risks in patients with chronic obstructive pulmonary disease (COPD). Another arm, the MULTIFIT Cardiac Rehabilitation program, reduces hospital visits for patients with coronary artery disease (CAD) and can save money. Additionally, some participants may enroll in a traditional cardiac rehabilitation program as a comparator. Overall, these programs provide effective care at home, making it more convenient and safe for patients. ^{1 2 5 6 7}

Who Is on the Research Team?

Amit J Shah, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for veterans who've had a heart attack in the last year, stable chest pain, heart surgery like bypass or valve replacement, angioplasty or stenting, heart transplants, or other specific heart conditions. They must be eligible for cardiac rehab and not have uncontrolled health issues like severe diabetes or high blood pressure.

Inclusion Criteria

I have had a heart or heart-lung transplant.

My chest pain is stable and not worsening.

You have a diagnosis from a specific doctor referred for this study.

Exclusion Criteria

I do not have a fever or any sudden illness.

I have symptoms of heart failure that affect my daily activities.

I have a condition that affects blood flow to my limbs and prevents me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a smartphone-delivered in-home cardiac or pulmonary rehabilitation program

12 weeks

Regular telephone calls and app-based interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

In-person visits at Week 12 and Week 24

What Are the Treatments Tested in This Trial?

Interventions

• Movn Pulmonary Rehabilitation
• MULTIFIT Cardiac Rehabilitation
• Standard of Care Cardiac Rehabilitation

Trial Overview

The study tests if a smartphone app and phone calls can help deliver better cardiac rehabilitation at home compared to usual care. It looks at whether patients stick with the program better, manage their symptoms well, learn more about their condition, and if it reduces hospital visits.

How Is the Trial Designed?

Group I: Pulmonary Rehabilitation - Movn Program Experimental Treatment 1 Intervention

Participants with stable chronic obstructive pulmonary disease (COPD) or hospitalized with an acute exacerbation of COPD will undergo an in-home pulmonary rehabilitation program.

Group II: Cardiac Rehabilitation - Movn Program Experimental Treatment 1 Intervention

Participants with coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD) who are eligible for cardiac rehabilitation will undergo an in-home program.

Group III: Traditional Cardiac Rehabilitation Active Control 1 Intervention

Participants enrolled in a facility's traditional cardiac rehabilitation program will be seen at baseline and during a 12 and 24 week follow-up visit.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Atlanta VA Medical Center

Collaborator

Trials

28

Recruited

69,700+

Published Research Related to This Trial

This review aims to evaluate how effective activity-monitoring devices and mobile applications are in improving physical activity and health outcomes for patients with cardiovascular disease undergoing cardiac rehabilitation, highlighting their potential role in supporting long-term exercise habits.

The review will analyze systematic reviews and meta-analyses of randomized controlled trials, ensuring a comprehensive assessment of the impact of these technologies on patient outcomes, with a focus on varying effectiveness based on patient characteristics and rehabilitation stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of activity-monitoring devices in patients with cardiovascular disease participating in cardiac rehabilitation programs: an umbrella review protocol. Dafny, HA., Champion, S., Gebremichael, LG., et al.[2023]

A systematic evaluation of 3121 mobile health apps for cardiac rehabilitation identified nine that met quality standards, with an average quality score of 3.0 out of 5, indicating a generally high quality of available apps.

The top-rated apps, 'My Cardiac Coach' and 'Love My Heart for Women,' scored above 4.0 in quality, functionality, and adherence to American Heart Association guidelines, suggesting they are effective tools for supporting patients in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Structured Review of Commercially Available Cardiac Rehabilitation mHealth Applications Using the Mobile Application Rating Scale. Meddar, JM., Ponnapalli, A., Azhar, R., 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]

A smartphone-enabled, home-based cardiac rehabilitation program was found to be feasible for veterans with coronary heart disease, with 13 out of 18 participants completing the full 12-week intervention.

Participants showed significant improvements in functional capacity and systolic blood pressure, indicating that this approach can effectively enhance health outcomes while maintaining high levels of patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-enabled Cardiac Rehabilitation Program in Male Veterans With Previous Clinical Evidence of Coronary Heart Disease. Harzand, A., Witbrodt, B., Davis-Watts, ML., et al.[2023]

A study involving 60 heart failure patients showed that those receiving home cardiac rehabilitation guided by mobile Internet technology had significantly better outcomes in exercise tolerance and quality of life after 12 weeks compared to those receiving standard rehabilitation.

The observation group demonstrated improved cardiac function, as indicated by better results in the 6-minute walking test and other cardiac health metrics, highlighting the efficacy of mobile technology in enhancing patient compliance and rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Mobile Internet Technology in Health Management of Heart Failure Patients Guiding Cardiac Rehabilitation. Liu, T., Liu, M.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8653769/

Retrospective Analysis and Forecasted Economic Impact of ...

Cardiac rehabilitation (CR) is recommended for patients with coronary artery disease (CAD) to reduce the risk of hospital readmission and ...

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ahajournals.org

ahajournals.org/doi/10.1161/cir.0000000000000663

Home-Based Cardiac Rehabilitation: A Scientific Statement ...

CR programs reduce morbidity and mortality rates in adults with ischemic heart disease, heart failure, or cardiac surgery but are significantly ...

3.

ajconline.org

ajconline.org/article/S0002-9149(23)00828-7/abstract

Cost Analysis of Remote Cardiac Rehabilitation Compared ...

The cost of cardiac rehabilitation was lower in those enrolled in Movn RCR ($1,377/patient, p = 0.002). The all-cause and cardiovascular-related ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02791685

Study Details | NCT02791685 | Smartphone Delivered In- ...

The goal of this study is to determine if a remote cardiac or pulmonary rehabilitation program delivered via a smartphone application and regular telephone ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666602222000258

Cardiac rehabilitation - The answer for the second chance

HBCR allows more flexibility and provides a safe and effective CR alternative, 24-h-a-day, 7-days- a-week, in the privacy and safety of home. HBCR is endorsed ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38533308/

Safety and long-term outcomes of remote cardiac ...

Conclusions: RDCR can act as a safe alternative delivery mode of cardiac rehabilitation (CR). The low long-term rates of reported SAEs and re- ...

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jacc.org

jacc.org/doi/abs/10.1016/j.jacc.2019.03.008

Home-Based Cardiac Rehabilitation: A Scientific Statement ...

CR programs reduce morbidity and mortality rates in adults with ischemic heart disease, heart failure, or cardiac surgery but are significantly underused, with ...