Home-Based Cardiac Rehabilitation for Heart Failure
(MOBILE HEART Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University Medical Center
Disqualifiers: Stage D heart failure, NYHA class IV, Congenital heart disease, Pregnancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.
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 study team or your doctor.
What data supports the effectiveness of the treatment Home-Based Cardiac Rehabilitation for Heart Failure?
Home-Based Cardiac Rehabilitation (HBCR) has been shown to be beneficial for patients with cardiovascular disease, and studies suggest it can manage cardiovascular risk factors effectively. While specific outcomes for heart failure patients are not fully known, HBCR has been successfully used in other countries and may offer similar benefits to traditional center-based programs.
12345Is home-based cardiac rehabilitation safe for humans?
The safety of home-based cardiac rehabilitation (HBCR) is not well-documented, but it is considered a reasonable option for clinically stable low- to moderate-risk patients who cannot attend traditional programs. More research is needed to fully understand its safety across different patient groups.
13456How is the home-based cardiac rehabilitation treatment different from other treatments for heart failure?
Home-based cardiac rehabilitation (HBCR) is unique because it allows patients to participate in rehabilitation from their own homes, which can increase participation rates compared to traditional center-based programs. It also offers real-time monitoring of exercise and health status, which can help manage heart failure more effectively, especially during times when in-person visits are challenging, like during the COVID-19 pandemic.
14578Eligibility Criteria
This trial is for individuals with heart failure who are unable to participate in center-based cardiac rehabilitation. Participants must have access to a smartphone or tablet and be willing to use an app and digital tools as part of the intervention.Inclusion Criteria
I have heart failure, was hospitalized for it within the last year, and see a doctor at VUMC.
Randomized Controlled Trial: Willingness to continue and participate in the study visits and other study activities required for the RCT
Exclusion Criteria
Roll-in Phase: Unwilling or unable to provide informed consent for participation in the RCT, requiring a walker or unable to get out of a chair/bed on their own and walk independently, age < 18 years, Stage D HF, NYHA class IV symptoms, congenital heart disease, pregnant, Group 1 pulmonary hypertension, moderate-severe or severe valvular heart disease, physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments, planned surgery within 3 months, recent or planned pacemaker or internal cardioverter defibrillator placement or revision, prior Cardiomems placement or planned in next 3 months, planned discharge to certain facilities, indication of unsafe participation by treating provider or study team physician, participation in any ongoing randomized trial that has not completed follow-up
Randomized Controlled Trial: Non-adherence to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 compliant days, unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Roll-in
Participants undergo a brief roll-in period before randomization
1 week
Treatment
Participants receive either standard care or home-based cardiac rehabilitation using a mobile health intervention
12 weeks
Periodic video calls with exercise physiologist
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Participant Groups
The study is testing a home-based cardiac rehabilitation (HBCR) program delivered through an app against usual care without this program. It aims to improve physical activity, quality of life, and reduce clinical events by focusing on key health behaviors.
2Treatment groups
Experimental Treatment
Active Control
Group I: Home-based cardiac rehabilitation mobile health interventionExperimental Treatment1 Intervention
Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets.
Group II: ControlActive Control1 Intervention
Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living.
Home-Based Cardiac Rehabilitation is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Cardiac Rehabilitation for:
- Coronary artery disease
- Heart failure
- Post-myocardial infarction rehabilitation
- Post-percutaneous coronary intervention rehabilitation
- Post-coronary artery bypass grafting rehabilitation
🇺🇸 Approved in United States as Cardiac Rehabilitation for:
- Coronary artery disease
- Heart failure
- Post-myocardial infarction rehabilitation
- Post-percutaneous coronary intervention rehabilitation
- Post-coronary artery bypass grafting rehabilitation
🇨🇦 Approved in Canada as Cardiac Rehabilitation for:
- Coronary artery disease
- Heart failure
- Post-myocardial infarction rehabilitation
- Post-percutaneous coronary intervention rehabilitation
- Post-coronary artery bypass grafting rehabilitation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
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Who Is Running the Clinical Trial?
Vanderbilt University Medical CenterLead Sponsor
References
Home Based Cardiac Rehabilitation Participation Among Patients With Heart Failure. [2023]Patients with Heart Failure (HF) have significant morbidity and mortality. Home Based Cardiac Rehabilitation (HBCR) is a form of Cardiac Rehabilitation (CR) which has been proven beneficial for the patients with cardiovascular disease; However, cardiovascular outcomes in patients with HF who was referred to HBCR is not known.
The Effect of Home-Based Cardiac Rehabilitation on Cardiovascular Risk Factors Management. [2023]To compare the efficacy of home-based cardiac rehabilitation (HBCR) and center-based cardiac rehabilitation (CBCR) in cardiovascular risk factor management.
Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. [2022]Cardiac rehabilitation (CR) is an evidence-based intervention that uses patient education, health behavior modification, and exercise training to improve secondary prevention outcomes in patients with cardiovascular disease. CR programs reduce morbidity and mortality rates in adults with ischemic heart disease, heart failure, or cardiac surgery but are significantly underused, with only a minority of eligible patients participating in CR in the United States. New delivery strategies are urgently needed to improve participation. One potential strategy is home-based CR (HBCR). In contrast to center-based CR services, which are provided in a medically supervised facility, HBCR relies on remote coaching with indirect exercise supervision and is provided mostly or entirely outside of the traditional center-based setting. Although HBCR has been successfully deployed in the United Kingdom, Canada, and other countries, most US healthcare organizations have little to no experience with such programs. The purpose of this scientific statement is to identify the core components, efficacy, strengths, limitations, evidence gaps, and research necessary to guide the future delivery of HBCR in the United States. Previous randomized trials have generated low- to moderate-strength evidence that HBCR and center-based CR can achieve similar improvements in 3- to 12-month clinical outcomes. Although HBCR appears to hold promise in expanding the use of CR to eligible patients, additional research and demonstration projects are needed to clarify, strengthen, and extend the HBCR evidence base for key subgroups, including older adults, women, underrepresented minority groups, and other higher-risk and understudied groups. In the interim, we conclude that HBCR may be a reasonable option for selected clinically stable low- to moderate-risk patients who are eligible for CR but cannot attend a traditional center-based CR program.
Home-Based Cardiac Rehabilitation: EXPERIENCE FROM THE VETERANS AFFAIRS. [2023]The conceptual utility of home-based cardiac rehabilitation (HBCR) is widely acknowledged. However, data substantiating its effectiveness and safety are limited. This study evaluated effectiveness and safety of the Veterans Affairs (VA) national HBCR program.
Disease management using home-based cardiac rehabilitation for patients with heart failure. [2023]Home-based cardiac rehabilitation (HBCR) is expected to address the low participation rate in cardiac rehabilitation; however, it is not covered by insurance in Japan, and the optimal method for monitoring a patient's condition during exercise has not been determined. Patients hospitalized for heart failure often deteriorate soon after discharge and require appropriate disease monitoring. In this report, we describe cases in which real-time monitoring of exercise intensity, electrocardiography, and video chat during HBCR was useful in the management of heart failure. Furthermore, the use of HBCR enabled frequent disease monitoring, even during the coronavirus disease 2019 pandemic, and timely medicine adjustment.
Safety of home-based cardiac rehabilitation: A systematic review. [2022]Cardiac rehabilitation is an evidence-based intervention that aims to improve health outcomes in cardiovascular disease patients, but it is largely underutilized. One strategy for improving utilization is home-based cardiac rehabilitation (HBCR). Previous research has shown that HBCR programs are feasible and effective. However, there is a lack of evidence on safety issues in different cardiac populations. This systematic review aimed to provide an evidence-based overview of the safety of HBCR.
Examining the effectiveness of home-based cardiac rehabilitation programs for heart failure patients with reduced ejection fraction: a critical review. [2023]Heart failure (HF) is the most common cardiovascular reason for hospital admission, particularly among patients older than 60 years old. Heart failure with reduced ejection fraction (HFrEF) comprises approximately 50% of all heart failure cases. Home-based cardiac rehabilitation (HBCR) is an alternative option to enhance the participation rate in cardiac rehabilitation (CR) interventions for patients who are not able to attend center-based cardiac rehabilitation (CBCR). The purpose of this review is to clarify the extent to which present studies of HBCR align with the core components defined by both the European Society of Cardiology (ESC) and the British Association for Cardiac Prevention and Rehabilitation (BACPR).
Effects of exercise-based cardiac rehabilitation delivery modes on exercise capacity and health-related quality of life in heart failure: a systematic review and network meta-analysis. [2022]This review aimed to compare the relative effectiveness of different exercise-based cardiac rehabilitation (ExCR) delivery modes (centre-based, home-based, hybrid and technology-enabled ExCR) on key heart failure (HF) outcomes: exercise capacity, health-related quality of life (HRQoL), HF-related hospitalisation and HF-related mortality.