Digital Monitoring for Coronary Artery Disease

Overseen By Lina Du, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: None

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital monitoring program for individuals with coronary heart disease who have recently undergone PCI, a procedure to open blocked heart arteries. The trial aims to determine if remote monitoring and text reminders improve health management compared to regular care. One group of participants will receive devices to monitor blood pressure and text reminders about exercise and doctor visits, while the other group will not. Individuals with coronary heart disease treated with PCI at UC Davis Health may qualify for this trial. The findings aim to enhance patient care and support lifestyle changes after heart procedures. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance recovery and long-term health management.

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 is best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this telemonitoring program is safe for patients with coronary artery disease?

Research shows that remote patient monitoring (RPM) is generally safe and well-received by patients. Studies have found that RPM can lead to positive outcomes, enhancing safety and helping patients adhere to their treatment plans. Patients using this type of digital monitoring often report improved mobility and daily functioning.

Telehealth, which includes digital monitoring, has also been safely used to manage heart conditions, such as detecting irregular heartbeats and controlling high blood pressure. These technologies help patients manage their health from home, reducing the need for hospital visits.

Overall, using digital monitoring after heart procedures like PCI appears safe, with no major safety issues reported in past studies. This makes it a promising option for patients seeking to improve their care after such procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of digital monitoring to enhance recovery for coronary artery disease patients. Unlike traditional care, which often relies heavily on routine follow-ups and patient-initiated management, this approach integrates technology by using blood pressure monitoring and sending text message reminders for cardiac rehabilitation and lifestyle counseling. This method aims to engage patients more actively in their own care, potentially improving adherence to treatment plans and overall outcomes. The convenience and real-time feedback offered by digital tools could lead to more personalized and timely interventions, setting it apart from conventional care methods.

What evidence suggests that digital monitoring is effective for coronary artery disease?

Research has shown that digital healthcare can aid patients with coronary artery disease (CAD) in recovering more effectively after hospital discharge. Some studies suggest that digital monitoring can enhance health by reducing the risk of death and illness related to heart disease. However, limited data exists on how remote monitoring specifically affects CAD patients. In this trial, participants will be discharged with either conventional care or with LiveCare and text message intervention. A detailed review found that remote patient monitoring can enhance patient safety, adherence to treatment plans, and quality of life. While digital health technologies appear promising, their impact on reducing death rates and major heart issues remains unproven. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with coronary heart disease who have undergone a procedure called percutaneous coronary intervention (PCI) and are followed up at UC Davis Health. It's not suitable for individuals who don't meet these specific conditions.

Inclusion Criteria

I have coronary heart disease and received a stent at UC Davis Health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote monitoring and text-based follow-up, with health goals and education on using the telemonitoring application

6 months

Daily messages for 1 week, then weekly reminders

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Monitoring

Trial Overview The study compares standard care with a telemonitoring program that includes remote monitoring, text-based follow-ups, health goals, education on using the app, and devices. The goal is to see if this reduces adverse cardiovascular events after PCI.

How Is the Trial Designed?

Group I: Discharged with LiveCare and Text Message Intervention Active Control 2 Interventions

Patients receive blood pressure monitoring and text messages reminders for enrollment in cardiac rehab, follow up appointment, diet and exercise counseling.

Group II: Discharged with Conventional Care Placebo Group 1 Intervention

Patients do not receive blood pressure monitoring and text messages reminders for enrollment in cardiac rehab, follow up appointment, diet and exercise counseling.

Digital Monitoring is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Digital Monitoring for:

• Post-PCI care
• Cardiovascular disease management
• Blood pressure monitoring

Approved in European Union as Telemonitoring for:

• Cardiovascular disease prevention
• Post-PCI care
• Chronic disease management

Approved in Canada as Remote Patient Monitoring for:

• Post-PCI care
• Cardiovascular health monitoring
• Lifestyle modification support

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

Remote patient monitoring (RPM) has been identified as a potentially cost-effective method for managing cardiovascular disease (CVD) in the U.S., particularly when considering long-term outcomes, based on a systematic review of 14 studies published between 2011 and 2021.

While some studies indicated higher costs with RPM compared to usual care, analyses from payer and healthcare perspectives showed that RPM can lead to better clinical effectiveness and is cost-effective at a threshold of $50,000 per Quality-Adjusted Life-Year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic evaluation and costs of remote patient monitoring for cardiovascular disease in the United States: a systematic review. Zhang, Y., Peña, MT., Fletcher, LM., et al.[2023]

Remote patient monitoring (RPM) is a practical tool for tracking physical activity in outpatient care, providing more reliable data than self-reports, as demonstrated in four pilot studies across various medical specialties.

RPM can enhance the management of chronic diseases and rehabilitation by offering clinicians objective feedback on patient progress, although attention must be given to ensure all populations can access these digital health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. McCarthy, M., Jevotovsky, D., Mann, D., et al.[2023]

Remote patient monitoring (RPM) can effectively identify early signs of COVID-19 infection in patients with chronic respiratory diseases, as demonstrated in three case reports involving 9 patients out of 1000 enrolled in a monitoring program.

The RPM system, which includes wearable health monitors and a smartphone app, detected physiological changes in patients at different stages of infection, allowing for earlier diagnosis and intervention, highlighting its potential for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Identification of COVID-19 Infection Using Remote Cardiorespiratory Monitoring: Three Case Reports. Polsky, M., Moraveji, N.[2021]

Patients with hypertension at high-remote patient monitoring (RPM) practices experienced a 3.3% increase in medication fills and a 1.3% increase in unique medications received, indicating improved management of their condition.

Despite better medication management and fewer acute care encounters, patients at high-RPM practices had a $274 increase in total hypertension-related spending, suggesting that while RPM improves care, it may also lead to higher overall costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients With Hypertension : An Observational Study. Tang, M., Nakamoto, CH., Stern, AD., et al.[2023]

Remote patient monitoring (RPM) has the potential to significantly improve the outpatient management of heart failure (HF) by addressing gaps in evidence-based therapies and enhancing the prediction and management of clinical decompensation.

The review highlights key components of effective RPM, including patient data collection and analysis, and identifies emerging digital tools that could enhance clinical efficacy in HF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Patient Monitoring in Heart Failure: Factors for Clinical Efficacy. Bhatia, A., Maddox, TM.[2022]

Remote patient monitoring (RPM) for cardiac electrophysiological conditions, including the use of cardiac implantable electronic devices (CIEDs), has been shown to enhance care quality, increase patient satisfaction, and be cost-effective, as supported by various studies.

Recent advancements in RPM include the integration of wearable technologies, such as the Apple Watch, and the establishment of networks like the American College of Cardiology's digital transformation initiative, which aim to improve monitoring and management of cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Medicine and Evolution of Remote Patient Monitoring in Cardiac Electrophysiology: A State-of-the-Art Perspective. Atreja, A., Francis, S., Kurra, S., et al.[2020]

Remote patient monitoring (RPM) significantly reduces the number of deaths and hospitalizations in chronic heart failure patients, based on a meta-analysis of 20 randomized controlled trials and 12 cohort studies involving over 8,600 patients.

The protective effects of RPM were more pronounced in cohort studies compared to randomized controlled trials, suggesting that RPM is an effective management strategy for improving outcomes in chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of remote monitoring of heart failure patients. Klersy, C., De Silvestri, A., Gabutti, G., et al.[2022]

Remote patient monitoring (RPM) for heart failure patients allows for the wireless transmission of vital physiological data to healthcare providers, enabling timely interventions when health metrics exceed safe thresholds.

The use of various RPM devices, including scales and blood pressure monitors, can enhance patient engagement in their cardiovascular care and may help alleviate the overall burden of heart failure on healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Monitoring Devices and Heart Failure. Gupta, K., Mastoris, I., Sauer, AJ.[2023]

The ETAPES funding program in France, initiated in 2016 and operational since 2018, supports remote patient monitoring (RPM) specifically for patients with chronic heart failure (CHF) who are at medium or high risk of re-hospitalization, emphasizing the importance of patient education and training in this model of care.

The Satelia® RPM solution focuses on symptomatic monitoring, allowing patients to report their health status through simple questionnaires rather than relying on connected devices, which may enhance patient engagement and ease of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia® Cardio). Pages, N., Picard, F., Barritault, F., et al.[2022]

Citations

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Effectiveness of digital healthcare to improve clinical ... Digital healthcare demonstrates superior post-discharge optimization of CAD outcomes, significantly attenuating mortality and morbidity. Subject ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05713565

A Digital Care Solution for Coronary Artery Disease Patients However, currently, there is still limited data to draw from on the effectiveness of digitally delivered remote monitoring and patient support programs for CAD ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X23005434

Digital Health Programs to Reduce Readmissions in ... There was no significant reduction for mortality outcomes (RR: 1.72; 95% CI: 0.64-4.64) or major adverse cardiovascular events (RR: 0.68; 95% CI: 0.40-1.15).

4. nature.com nature.com/articles/s41746-024-01182-w

A systematic review of the impacts of remote patient ... In this systematic review, we addressed this gap by examining the impacts of RPM interventions on patient safety, adherence, clinical and quality of life ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06114615

Digital Monitoring for Patients Post Coronary Interventions ... The study aims to support patients immediately after percutaneous coronary intervention (PCI) by implementing a telemonitoring program. Eligible patients have ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11258279/

A systematic review of the impacts of remote patient ... RPM interventions demonstrated positive outcomes in patient safety and adherence. RPM interventions also improved patients' mobility and functional statuses.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation The review examines critical factors that influence the success of digital CR, such as digital literacy, concerns about data security, adherence to digital ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001107

An Overview of Telehealth in the Management ... Telehealth has been used to facilitate the management of many CVDs, such as arrhythmia detection, heart failure, hypertension, coronary artery ...