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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: LiveCare; Behavioral: Text Messages; Other: Conventional Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Surabhi Atreja, MD; Phone Number: (916) 734-2011; Email: smatreja@ucdavis.edu
• Study Contact Backup: Name: Lina Du, BS

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California, Davis Medical Center Division of Cardiovascular Medicine
      • Contact: Surabhi Atreja, MD; Phone Number: 916-734-6082; Email: smatreja@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Includes patients with coronary heart disease diagnosis and treatment with PCI who follow up at University of California Davis Health.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Discharged with LiveCare and Text Message Intervention; Patients receive blood pressure monitoring and text messages reminders for enrollment in cardiac rehab, follow up appointment, diet and exercise counseling.	Device: LiveCare; Patient use LiveCare device to monitor their blood pressure and data is transmitted to dashboard.; Other Names: Blood Pressure and Weight Monitoring; Behavioral: Text Messages; Patients also receive text messages after their PCI procedure for follow up appointment reminders, enrollment in cardiac rehab, and diet and exercise counseling.
Sham Comparator: Discharged with Conventional Care; 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; No digital monitoring with LiveCare device and no text messages.

What is the study measuring?

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	Time Frame
lipid profile	one month, six months
Major adverse cardiovascular events (MACE)	one month, six months

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cardiac rehabilitation; digital monitoring; post-PCI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Physical Examination; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Blood Pressure
• Other Study ID Numbers: 1972752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes