Digital Monitoring for Coronary Artery Disease
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Davis
Disqualifiers: None
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The study aims to support patients immediately after percutaneous coronary intervention (PCI) by implementing a telemonitoring program. Eligible patients have coronary heart disease and undergo PCI. The intervention group receives remote monitoring and text-based follow-up, with established health goals and education on using the telemonitoring application, along with necessary devices. The control group gets standard care. Outcomes measured include blood pressure, LDL levels, patient satisfaction, revascularization, and mortality. The study findings will enhance patient care after PCI and contribute evidence for widespread telemonitoring implementation in healthcare systems, aiding medical therapy and lifestyle modifications.
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 data supports the effectiveness of the treatment Digital Monitoring, Telemonitoring, Remote Patient Monitoring (RPM), Digital Care Program for Coronary Artery Disease?
Research shows that remote patient monitoring (RPM) has improved medical outcomes and care management for chronic diseases like heart failure, which is similar to coronary artery disease. RPM helps by collecting and analyzing patient data, allowing healthcare providers to make better decisions and potentially improve patient outcomes.
12345Is remote patient monitoring safe for humans?
Remote patient monitoring (RPM) has been used safely in managing chronic conditions like heart failure and hypertension. While the focus is often on its effectiveness, the studies suggest that RPM is generally safe for human use.
14567How is digital monitoring different from other treatments for coronary artery disease?
Digital monitoring for coronary artery disease is unique because it uses technology to remotely collect and analyze patient health data, allowing for continuous monitoring and timely interventions without the need for frequent in-person visits. This approach can improve disease management by providing real-time insights and engaging patients in their own care, which is different from traditional treatments that rely on periodic check-ups.
23589Eligibility Criteria
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.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: Discharged with LiveCare and Text Message InterventionActive Control2 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 CarePlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, Davis Medical Center Division of Cardiovascular MedicineSacramento, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
References
Early Identification of COVID-19 Infection Using Remote Cardiorespiratory Monitoring: Three Case Reports. [2021]The adoption of remote patient monitoring (RPM) in routine medical care requires increased understanding of the physiologic changes accompanying disease development and the proactive interventions that will improve outcomes.
Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. [2023]Remote patient monitoring (RPM) is a tool for patients to share data collected outside of office visits. RPM uses technology and the digital transmission of data to inform clinician decision-making in patient care. Using RPM to track routine physical activity is feasible to operationalize, given contemporary consumer-grade devices that can sync to the electronic health record. Objective monitoring through RPM can be more reliable than patient self-reporting for physical activity.
Economic evaluation and costs of remote patient monitoring for cardiovascular disease in the United States: a systematic review. [2023]Remote patient monitoring (RPM) has emerged as a viable and valuable care delivery method to improve chronic disease management. In light of the high prevalence and substantial economic burden of cardiovascular disease (CVD), this systematic review examines the cost and cost-effectiveness of using RPM to manage CVD in the United States.
Remote Patient Monitoring in Heart Failure: Factors for Clinical Efficacy. [2022]Despite clinical advances in its treatment, heart failure (HF) is associated with significant adverse clinical outcomes and is among the greatest drivers of healthcare utilization. Outpatient management of HF remains suboptimal, with gaps in the provision of evidence-based therapies, and difficulties in predicting and managing clinical decompensation. Remote patient monitoring (RPM) has the potential to address these issues, and thus has been of increasing interest to HF clinicians and health systems. Economic incentives, including increasing RPM reimbursement and HF readmission penalties, are also spurring increased interest in RPM. This review establishes a framework for evaluating RPM based on its various components: 1) patient data collection, 2) data transmission, analysis, and presentation, and 3) care team review and clinical action. The existing evidence regarding RPM in HF management is also reviewed. Based on the data, we identify RPM features associated with clinical efficacy and describe emerging digital tools that have the promise of addressing current needs.
Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia® Cardio). [2022]Remote patient monitoring (RPM) is a telehealth activity to collect and analyze patient health or medical data. Its use has expanded in the past decade and has improved medical outcomes and care management of non-communicable chronic diseases. However, implementation of RPM into routine clinical activities has been limited. The objective of this study was to describe the French funding program for RPM (known as ETAPES) and one of the RPM solution providers (Satelia®) dedicated to chronic heart failure (CHF).
Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients With Hypertension : An Observational Study. [2023]Remote patient monitoring (RPM) is a promising tool for improving chronic disease management. Use of RPM for hypertension monitoring is growing rapidly, raising concerns about increased spending. However, the effects of RPM are still unclear.
A meta-analysis of remote monitoring of heart failure patients. [2022]The purpose of this study was to assess the effect of remote patient monitoring (RPM) on the outcome of chronic heart failure (HF) patients.
Remote Monitoring Devices and Heart Failure. [2023]Remote patient monitoring (RPM) in patients with heart failure (HF) involves transmitting physiological data from devices to a health-care provider via a wireless connection with targeted interventions when values exceed the preset threshold. Devices used in telemonitoring range from weighing scales, blood pressure cuffs, and pulse oximeters to devices used to measure cardiac filling pressure and intrathoracic impedance using cardiac implantable electronic devices and wearables. Accordingly, RPM devices can potentially engage patients in their cardiovascular care and reduce the burden of HF in society.
Digital Medicine and Evolution of Remote Patient Monitoring in Cardiac Electrophysiology: A State-of-the-Art Perspective. [2020]With the evolution in digital medicine to identify and monitor cardiac electrophysiological (EP) conditions, increased access to cardiac implantable electronic devices (CIEDs), and reimbursements for non-face-to-face care, remote patient monitoring (RPM) is becoming a key part of the EP service line. RPM of cardiac electrophysiological conditions including the use of CIEDs has improved the quality of care and high patient satisfaction and proved to be cost-effective. The focus of this review is literature on RPM in EP, evidence from randomized trials, and observational studies including those of Apple Watch and future of CIEDs.