Digital Monitoring for Patients Post Coronary Interventions to Reduce Risk for Recurrent Adverse Cardiovascular Events
- Conditions
- Coronary Artery Disease
- Interventions
- Other: Conventional CareDevice: LiveCareBehavioral: Text Messages
- Registration Number
- NCT06114615
- Lead Sponsor
- University of California, Davis
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Includes patients with coronary heart disease diagnosis and treatment with PCI who follow up at University of California Davis Health.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Discharged with Conventional Care 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. Discharged with LiveCare and Text Message Intervention LiveCare Patients receive blood pressure monitoring and text messages reminders for enrollment in cardiac rehab, follow up appointment, diet and exercise counseling. Discharged with LiveCare and Text Message Intervention Text Messages Patients receive blood pressure monitoring and text messages reminders for enrollment in cardiac rehab, follow up appointment, diet and exercise counseling.
- Primary Outcome Measures
Name Time Method blood pressure, systolic and diastolic 1 month, 6 months patient rate of first follow up appointment 1 month, 6 month average ratings on the telehealth usability questionnaire six months assess patient satisfaction with the teleheath program with 12 questions, each 1-7 points. Total of 84 points; higher score indicates greater satisfaction
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
- Secondary Outcome Measures
Name Time Method Major adverse cardiovascular events (MACE) one month, six months lipid profile one month, six months
Trial Locations
- Locations (1)
University of California, Davis Medical Center Division of Cardiovascular Medicine
🇺🇸Sacramento, California, United States