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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06114615
• Other study ID #: 1972752
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: October 10, 2024

Study information

• Verified date: August 2023
• Source: University of California, Davis
• Contact: Surabhi Atreja, MD
• Phone: (916) 734-2011
• Email: smatreja[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 10, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• LiveCare
Patient use LiveCare device to monitor their blood pressure and data is transmitted to dashboard.

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.

Other:
• Conventional Care
No digital monitoring with LiveCare device and no text messages.

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center Division of Cardiovascular Medicine	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure, systolic and diastolic		1 month, 6 months
Primary	readmission rate		1 month, 6 months
Primary	enrollment rate in cardiac rehabilitation		1 month, 6 months
Primary	rate of non-compliance to medications prescribed at discharge		1 month, 6 months
Primary	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
Primary	patient rate of first follow up appointment		1 month, 6 month
Secondary	lipid profile		one month, six months
Secondary	Major adverse cardiovascular events (MACE)		one month, six months