Mobile Health Cardiac Rehabilitation for Ischemia

Overseen By Harmony Reynolds, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Non-ambulatory, Pregnant, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with INOCA, a heart condition characterized by chest pain or other symptoms without blocked arteries, using mobile health technology (mHealth-CR). Participants will use a smartphone app and a wearable device to track their activity and receive weekly counseling, aiming to improve overall health and quality of life. The trial compares this new method to regular medical care. It seeks individuals diagnosed with INOCA who can move independently and are comfortable using a smartphone app. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future care for INOCA patients.

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 trial coordinators or your doctor.

What prior data suggests that this mobile health cardiac rehabilitation is safe for patients with ischemia?

Research has shown that mobile health technology, such as the mHealth-CR program, is generally safe for individuals with heart problems. A review of remote heart rehab programs found no increase in long-term risks for participants. Thus, using apps and wearable devices to track activity and heart rate is both easy and safe.

Another study on home-based heart rehab found it safe and effective for people with heart disease, improving health without adding risk.

Overall, these findings suggest that mHealth-CR is a safe choice for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mobile Health Cardiac Rehabilitation (mHealth-CR) because it revolutionizes cardiac rehab for ischemia by integrating technology into patient care. Unlike traditional cardiac rehabilitation, which typically involves in-person sessions, mHealth-CR leverages a smartphone app and wearable devices like a Fitbit or Apple Watch to track activity and heart rate, making it convenient and accessible. This method allows for daily therapist-directed activities and weekly phone support, providing personalized care from the comfort of home. By combining technology with rehabilitation, mHealth-CR aims to improve patient engagement and outcomes in managing ischemic heart conditions.

What evidence suggests that mHealth-CR is effective for cardiac rehabilitation in patients with INOCA?

Research has shown that mobile health tools for cardiac rehabilitation (mHealth-CR), which participants in this trial may receive, can help people with heart conditions improve their health. Some studies suggest that mobile apps for cardiac rehab can simplify tracking physical activity and keep patients engaged. These apps often include features like goal setting and automatic exercise tracking, which have been linked to better health outcomes. However, other studies found that mHealth-CR might not significantly enhance exercise ability or improve some health measures compared to regular care. While results are mixed, mHealth-CR has the potential to increase patient involvement and make rehab services more accessible. ^{2 4 6 7 8}

Who Is on the Research Team?

Harmony Reynolds, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals with INOCA, which means they have symptoms of heart issues but no blocked arteries. They must be part of the NYU Langone Health or Emory University Medical Center system and willing to use a wearable device and communicate with an exercise therapist for 3 months.

Inclusion Criteria

I have INOCA diagnosed with a CT scan or angiography.

Exclusion Criteria

Pregnant

Unable to read and communicate in English since the app content is currently only available in English.

I regularly use a walker for mobility.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mHealth-CR intervention including activity tracking, weekly counseling, and exercise documentation for 3 months

12 weeks

Weekly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at 6 months and 1 year

9 months

What Are the Treatments Tested in This Trial?

Interventions

• mHealth-CR

Trial Overview

The study tests if a mobile health cardiac rehab program (mHealth-CR), involving activity tracking, weekly counseling, and exercise documentation can improve symptoms, function, and life quality in INOCA patients compared to usual care.

How Is the Trial Designed?

Group I: mHealth-Cardiac Rehabilitation (CR) Experimental Treatment 3 Interventions

Participants in the mHealth-CR arm will receive daily therapist-directed activity and weekly phone calls, use a mHealth-CR app to track activity, heart rate and access educational materials, and use a wearable wrist activity monitoring device (such as Fitbit or Apple Watch).

Group II: Usual Care Active Control 1 Intervention

Participants in usual care arm will receive standard medical care as determined by their physician. They will also use a wearable wrist activity monitoring device.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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]

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]

The mobile health augmented cardiac rehabilitation (MCard) program significantly improved physical activity and healthy eating behaviors among post-acute coronary syndrome patients over a six-month period, with notable increases in healthy eating scores and reduced salt intake.

MCard was shown to be a feasible intervention that led to lasting behavior modifications in patients, although it did not significantly affect medication compliance, smoking behavior, or self-monitoring of blood pressure and weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Health Augmented Cardiac Rehabilitation on Behavioural Outcomes among Post-acute Coronary Syndrome Patients: A Randomised Controlled Trial. Manzoor, S., Hisam, A., Aziz, S., et al.[2021]

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]

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]

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 randomized controlled trial involving 160 post-acute coronary syndrome patients showed that mobile health augmented cardiac rehabilitation (MCard) significantly improved health-related quality of life (HRQoL) scores, including physical and mental health components, at both 12 and 24 weeks compared to standard care.

All domains of the MacNew quality of life myocardial infarction tool (social, emotional, physical, and global) also showed significant improvement in the MCard group, indicating that this intervention can enhance overall patient well-being after cardiac events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Health Augmented Cardiac Rehabilitation (MCard) on health-related quality of life among post-acute coronary syndrome patients: A randomized controlled trial. Hisam, A., Haq, ZU., Aziz, S., et al.[2022]

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]

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