250 Participants Needed

Mobile Health Cardiac Rehabilitation for Ischemia

JD
HR
Overseen ByHarmony Reynolds, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.24678

Who Is on the Research Team?

HR

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.
See 10 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: mHealth-Cardiac Rehabilitation (CR)Experimental Treatment3 Interventions
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

Rehabilitation at Home Using Mobile Health for Older ...In this randomized clinical trial of mHealth-CR vs usual care, mHealth-CR did not significantly increase 6MWD or result in improvements in secondary outcomes.
Rehabilitation Using Mobile Health for Older Adults With ...This study aims to describe the design of the rehabilitation using mobile health for older adults with ischemic heart disease in the home setting (RESILIENT) ...
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.
Long-Term Outcomes of Digital Cardiac RehabilitationMobile applications that have improved patient clinical outcomes often include features like data syncing and automatic recording during exercise, enabling goal ...
Efficacy of a Mobile Health App (eMOTIVA) Regarding ...This study aimed to compare the efficacy of an mHealth intervention involving the eMOTIVA app and that of usual care regarding compliance with cardiac ...
A Dual-Modality Home-Based Cardiac Rehabilitation Program ...Background: Cardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD).
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 ...
Study Details | NCT03978130 | Rehabilitation at Home ...This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age ≥65) with IHD compared with standard traditional cardiac ...
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