Digital Monitoring for Patients Post Coronary Interventions to Reduce Risk for Recurrent Adverse Cardiovascular Events

Study Overview
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Brief Summary
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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.

Detailed Description
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The study involves 200 participants divided into intervention and control groups, all diagnosed with coronary heart disease and treated with PCI. Upon discharge, the intervention group receives remote monitoring, text messages, and devices for self-management. Control group receives standard care. Recruitment is from cardiology and primary care clinics, with interpreters available. Study coordinator guides device setup during enrollment. Intervention group receives daily messages for a week, then weekly reminders and counseling. Messages are in English or Spanish as per preference. Patient data is collected, including demographics, medications, and outcomes such as blood pressure and readmission rates. Satisfaction is evaluated through surveys and interviews.

Official Title
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Digital Monitoring for Patients Post Coronary Interventions to Reduce Risk for Recurrent Adverse Cardiovascular Events

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: LiveCare
* Behavioral: Text Messages
* Other: Conventional Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Includes patients with coronary heart disease diagnosis and treatment with PCI who follow up at University of California Davis Health.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Discharged with LiveCare and Text Message Intervention<br>Patients receive blood pressure monitoring and text messages reminders for enrollment in cardiac rehab, follow up appointment, diet and exercise counseling. | Device: LiveCare<br>* Patient use LiveCare device to monitor their blood pressure and data is transmitted to dashboard.<br>* Other names: Blood Pressure and Weight Monitoring;Behavioral: Text Messages<br>* Patients also receive text messages after their PCI procedure for follow up appointment reminders, enrollment in cardiac rehab, and diet and exercise counseling.<br>|
| Sham Comparator: Discharged with Conventional Care<br>Patients do not receive blood pressure monitoring and text messages reminders for enrollment in cardiac rehab, follow up appointment, diet and exercise counseling. | Other: Conventional Care<br>* No digital monitoring with LiveCare device and no text messages.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure, systolic and diastolic |  | 1 month, 6 months | 
| readmission rate |  | 1 month, 6 months | 
| enrollment rate in cardiac rehabilitation |  | 1 month, 6 months | 
| rate of non-compliance to medications prescribed at discharge |  | 1 month, 6 months | 
| average ratings on the telehealth usability questionnaire | assess patient satisfaction with the teleheath program with 12 questions, each 1-7 points. Total of 84 points; higher score indicates greater satisfaction | six months | 
| patient rate of first follow up appointment |  | 1 month, 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile |  | one month, six months | 
| Major adverse cardiovascular events (MACE) |  | one month, six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital monitoring, cardiac rehabilitation, post-PCI