mHealth Intervention for Cardiac Rehabilitation

Overseen By Leana Goncalves Araujo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth University

Disqualifiers: Pregnant, Surgery, Other programs, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist people in cardiac rehabilitation (CR) by using activity trackers like Fitbits. The goal is to determine if tracking daily steps and sleep can improve physical activity, sleep, and overall quality of life for those in Phase III CR. This mobile health (mHealth) intervention requires participants to enroll in the CR program at Hope Clinic, wear a Fitbit, own a smartphone, and receive messages from the research team. The study targets individuals who are not overly active but wish to increase their physical activity safely. As an unphased trial, it offers a unique opportunity to explore innovative ways to enhance the rehabilitation experience.

Will I have to stop taking my current medications?

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

What prior data suggests that this mHealth intervention is safe for cardiac rehabilitation clients?

Research shows that mobile health (mHealth) apps, like the one used in this study, are generally safe for people with heart conditions. Studies have found that using these apps during heart rehabilitation can help reduce serious heart problems and lower the chances of needing to return to the hospital.

Tests on digital heart rehabilitation have yielded encouraging results. Patients handle these tools well, and they do not increase the risk of heart issues. Additionally, these apps can help track health goals like exercise and sleep, which benefit heart health.

Overall, studies suggest that mHealth tools are safe for use in heart rehabilitation and can even help improve health outcomes for people with heart disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth intervention for cardiac rehabilitation because it leverages digital technology to enhance patient engagement and accessibility. Unlike traditional cardiac rehab programs that often require in-person attendance, mHealth interventions allow patients to participate from home using mobile apps or other digital platforms. This approach can lead to increased adherence to rehabilitation exercises and lifestyle changes by providing real-time feedback and personalized support, making cardiac rehab more flexible and potentially more effective for patients who face barriers to attending in-person sessions.

What evidence suggests that this mHealth intervention is effective for cardiac rehabilitation?

Research has shown that mobile health (mHealth) tools, such as activity trackers, can significantly enhance physical activity and overall health in individuals with heart disease. Studies have found that these digital tools lower the risk of serious heart problems and reduce hospital readmissions. They also improve cholesterol levels, which are crucial for heart health. Additionally, incorporating mHealth in heart recovery programs has been linked to a better quality of life and increased physical activity. This trial will assess the effectiveness of mHealth tools in supporting heart health and recovery for participants recruited from the Phase III CR program at Hope Clinic. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are in Phase III Cardiac Rehabilitation (CR) at Hope Clinic. Participants must be able to walk, follow instructions, wear a Fitbit, and use a smartphone with text messaging. They should not be overly active or have upcoming surgery/travel plans within 8 weeks, nor should they be pregnant/lactating or involved in other health programs.

Inclusion Criteria

I am willing to get texts and calls from the research team.

Clients currently receiving Phase III CR at Hope Clinic

I can walk following instructions.

Exclusion Criteria

I do not have any surgeries or travel planned in the next 8 weeks.

Clients currently participating in other health promotion program

Clients who are pregnant or lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants use an activity tracker (i.e., Fitbit) to monitor daily steps and sleep patterns

8 weeks

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mhealth

Trial Overview

The study tests an mHealth intervention using activity trackers like Fitbit to monitor physical activity and sleep patterns of Phase III CR clients for 8 weeks. It aims to develop a protocol for self-monitoring and assess the impact on exercise habits, sleep quality, functional capacity, and overall life quality.

How Is the Trial Designed?

Group I: Hope Clinic Experimental Treatment 2 Interventions

Participants will be recruited from clients admitted to the Phase III CR program at Hope Clinic. An information sheet introducing this study will be provided to clients by the assigned therapist at the Hope clinic after admission.

Mhealth is already approved in United States, European Union for the following indications:

Approved in United States as MHealth Intervention for:

• Promoting Physical Activity in Cardiac Rehabilitation

Approved in European Union as MHealth Intervention for:

• Supporting Cardiac Rehabilitation through Physical Activity Monitoring

Who Is Running the Clinical Trial?

AdventHealth University

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

Cardiac rehabilitation is highly beneficial for various cardiovascular conditions but is often underutilized, indicating a need for improved patient engagement and support.

Digital technology can enhance traditional cardiac rehabilitation by providing flexible, accessible interventions that improve health outcomes and promote health equity, as outlined in this American Heart Association advisory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Technologies in Cardiac Rehabilitation: A Science Advisory From the American Heart Association. Golbus, JR., Lopez-Jimenez, F., Barac, A., et al.[2023]

A digital health intervention (DHI) combined with remote cardiac rehabilitation (CR) significantly improved access to CR, with 90% of participants completing the program out of 258 who consented from 1,643 referrals.

Participants in the DHI showed notable improvements in their 6-minute walk test distance and reductions in low-density lipoprotein cholesterol, along with a decrease in smoking rates, all without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. Harzand, A., Alrohaibani, A., Idris, MY., et al.[2023]

A survey of 74 adults with cardiovascular disease showed that 95% owned mobile phones and 77% were interested in receiving cardiac rehabilitation information via text messages, indicating a strong potential for mobile technology to enhance CR attendance.

A pilot study with 20 participants revealed that a 4-week healthy eating program delivered through mobile technology significantly improved self-efficacy related to heart-healthy eating, particularly in environmental self-efficacy, suggesting that text messaging is an effective method for delivering nutrition information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Disease Self-Management: Pilot Testing of an mHealth Healthy Eating Program. Dale, LP., Whittaker, R., Eyles, H., et al.[2022]

The study will evaluate the effectiveness of a mobile health augmented cardiac rehabilitation program (MCard) over 23-24 weeks for improving health-related quality of life (HRQoL) and clinical outcomes in 160 post-acute coronary syndrome (ACS) patients.

If successful, MCard could provide a cost-effective and resource-efficient rehabilitation option that can be scaled to other cardiac centers, especially important during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Augmented Cardiac Rehabilitation (MCard) in Post-Acute Coronary Syndrome Patients: A randomised controlled trial protocol. Hisam, A., Haq, ZU., Khan, Z., et al.[2022]

In a study involving 220 low and moderate risk patients undergoing cardiac rehabilitation, a mobile health (mHealth) intervention did not significantly improve physical activity levels, as measured by the 6-minute walk distance, after 6 months compared to usual care.

While the mHealth intervention showed no overall benefit at 6 months, there were some indications of improved outcomes at 3 months for certain users, particularly those using Fitbit devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a mobile health intervention to augment cardiac rehabilitation. Golbus, JR., Gupta, K., Stevens, R., et al.[2023]

A study involving post-myocardial infarction patients using wearable activity monitors linked to a customized app showed a significant reduction in systolic blood pressure compared to a control group, indicating potential cardiovascular benefits from this technology-enhanced rehabilitation approach.

While both groups reported similar changes in physical activity levels by the end of the cardiac rehabilitation program, the digitally monitored group demonstrated a trend towards achieving higher exercise intensity (measured in METS) at 12 weeks, suggesting that technology may help enhance engagement in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitally enabled cardiac rehabilitation following coronary revascularization: results from a single centre feasibility study. Hatch, V., Davies, WR.[2022]

A randomized controlled trial involving 170 adults with cardiovascular disease is testing a mobile phone-delivered exercise-based cardiac rehabilitation program to improve exercise capacity and functional outcomes compared to usual care.

The trial aims to assess not only the effectiveness of the mHealth program in increasing exercise behavior over six months but also its impact on cardiovascular risk factors and overall quality of life, potentially offering a scalable solution for cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HEART: heart exercise and remote technologies: a randomized controlled trial study protocol. Maddison, R., Whittaker, R., Stewart, R., et al.[2021]

In a study involving 1025 patients from a cardiac rehabilitation program, only 12% preferred to replace some in-person sessions with smartphone-based health interventions (mHealth), indicating limited interest in mHealth during the initial rehabilitation phase.

However, nearly 48% of patients expressed interest in using mHealth for continued exercise training after completing their rehabilitation, suggesting a potential for mHealth in long-term patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient interest in mHealth as part of cardiac rehabilitation in Switzerland. Marcin, T., Bengel, C., Goldberg, T., et al.[2021]

The VALENTINE Study is a randomized-controlled trial evaluating the effectiveness of a mobile health (mHealth) intervention to enhance physical activity in low- and moderate-risk cardiovascular patients, using smartwatches and tailored notifications to encourage exercise.

The primary outcome of the study is the change in 6-minute walk distance after 6 months, with secondary outcomes including daily step count, aiming to understand how mHealth technologies can sustain activity levels post-cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual AppLication-supported Environment To INcrease Exercise (VALENTINE) during cardiac rehabilitation study: Rationale and design. Jeganathan, VS., Golbus, JR., Gupta, K., et al.[2022]

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]

The mHealth program 'Text4Heart' significantly improved adherence to healthy lifestyle behaviors in adults with coronary heart disease (CHD) at 3 months compared to usual care, indicating its potential effectiveness as a complementary intervention.

While the intervention showed a positive impact on medication adherence and lifestyle changes initially, these effects were not sustained at the 6-month follow-up, suggesting the need for further research to evaluate long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial. Pfaeffli Dale, L., Whittaker, R., Jiang, Y., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11064579/

Effectiveness of mobile health applications on clinical ...

Mobile health apps have the potential to lower the incidence of major adverse cardiac events (MACEs), readmission rates, and blood lipids in patients with CHD.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation

Digital CR utilizes tools such as mobile applications, video conferencing, and AI-based interventions to effectively enhance PA, health outcomes, and QoL for ...

3.

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.

4.

nature.com

nature.com/articles/s41746-023-00921-9

A randomized trial of a mobile health intervention to ...

Mobile health (mHealth) interventions may enhance positive health behaviors, but randomized trials evaluating their efficacy are uncommon.

5.

pmc.ncbi.nlm.nih.gov

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

Effectiveness of Cardiac Rehabilitation With mHealth Through ...

Cardiovascular diseases are the leading cause of mortality worldwide, requiring support to manage symptoms and improve prognosis.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10964460/

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

To systematically review the safety and the long-term mortality and morbidity risk-rates of the remotely-delivered cardiac rehabilitation ...

7.

ahajournals.org

ahajournals.org/doi/10.1161/CIR.0000000000001150

Digital Technologies in Cardiac Rehabilitation: A Science ...

This American Heart Association science advisory was assembled to guide the development and implementation of digital cardiac rehabilitation interventions.