Clinical trial NCT06114615: Digital Monitoring for Patients Post Coronary Interventions to Reduce Risk for Recurrent Adverse Cardiovascular Events
Official title: Digital Monitoring for Patients Post Coronary Interventions to Reduce Risk for Recurrent Adverse Cardiovascular Events
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: post-PCI
digital monitoring
cardiac rehabilitation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: blood pressure, systolic and diastolic
timeFrame: 1 month, 6 months
measure: readmission rate
timeFrame: 1 month, 6 months
measure: enrollment rate in cardiac rehabilitation
timeFrame: 1 month, 6 months
measure: rate of non-compliance to medications prescribed at discharge
timeFrame: 1 month, 6 months
measure: average ratings on the telehealth usability questionnaire
timeFrame: six months
measure: patient rate of first follow up appointment
timeFrame: 1 month, 6 month
Secondary outcomes:
measure: lipid profile
timeFrame: one month, six months
measure: Major adverse cardiovascular events (MACE)
timeFrame: one month, six months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center Division of Cardiovascular Medicine
state: California
Study officials:
References: