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

Trial Summary

What is the purpose of this trial?

This is a multi-site phase II, 2:1 pragmatic randomized trial of 250 participants within the NYU Langone Health (NYULH) and Emory University Medical Center system to evaluate mobile health cardiac rehabilitation (mHealth-CR) in patients who meet clinical criteria for INOCA (ischemia and no obstructive coronary disease on imaging). Participants will be randomized to mHealth-CR or usual care. The study intervention takes place for 3 months which is the time period for most traditional CR programs. The overall study goals are threefold: 1) to evaluate whether an mHealth-CR intervention that includes activity tracking, weekly counseling, and exercise documentation, improves health status (i.e., symptoms, function, and quality of life) in patients with INOCA at 3 months; 2) to evaluate effects of the mHealth-CR intervention vs. usual care on physical activity and exercise capacity, general health status, and depressive symptoms (secondary endpoints). We will also evaluate effects on primary and secondary outcomes at 6 months and 1 year; and 3) to characterize engagement and elucidate any factors that limit engagement.

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 data supports the effectiveness of the treatment mHealth-CR for ischemia?

Research shows that mobile health cardiac rehabilitation (mHealth-CR) can improve health-related quality of life and behavioral outcomes in patients recovering from heart issues like acute coronary syndrome. This suggests that using mobile technology to support cardiac rehabilitation can help patients manage their heart health better. ^{1 2 3 4 5}

Is mobile health cardiac rehabilitation safe for humans?

The research does not specifically address safety concerns, but mobile health cardiac rehabilitation (mHealth-CR) is generally considered a way to improve access and participation in cardiac rehabilitation, which is known to be beneficial for heart health. ^{2 5 6 7 8}

How is the mHealth-CR treatment different from other treatments for ischemia?

The mHealth-CR treatment is unique because it uses mobile technology to deliver cardiac rehabilitation remotely, allowing patients to engage in their rehabilitation from home. This approach can help overcome barriers like distance and accessibility, making it easier for patients to participate in their recovery process compared to traditional in-person cardiac rehabilitation programs. ^{2 4 5 9 10}

Research Team

Harmony Reynolds, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

I regularly use a walker for mobility.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Pakistan 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. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiovascular Disease Self-Management: Pilot Testing of an mHealth Healthy Eating Program. [2022]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Mobile Health Augmented Cardiac Rehabilitation (MCard) in Post-Acute Coronary Syndrome Patients: A randomised controlled trial protocol. [2022]

4. Pakistan 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

HEART: heart exercise and remote technologies: a randomized controlled trial study protocol. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A Structured Review of Commercially Available Cardiac Rehabilitation mHealth Applications Using the Mobile Application Rating Scale. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Digital Technologies in Cardiac Rehabilitation: A Science Advisory From the American Heart Association. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Use of Smartphone Apps for Improving Physical Function Capacity in Cardiac Patient Rehabilitation: Systematic Review. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

VA FitHeart, a Mobile App for Cardiac Rehabilitation: Usability Study. [2022]