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

NCT ID: NCT06114615

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-01-01

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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

LiveCare

Intervention Type DEVICE

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

Text Messages

Intervention Type BEHAVIORAL

Patients also receive text messages after their PCI procedure for follow up appointment reminders, enrollment in cardiac rehab, and diet and exercise counseling.

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.

Group Type SHAM_COMPARATOR

Conventional Care

Intervention Type OTHER

No digital monitoring with LiveCare device and no text messages.

Interventions

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LiveCare

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

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Conventional Care

No digital monitoring with LiveCare device and no text messages.

Intervention Type OTHER

Other Intervention Names

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Blood Pressure and Weight Monitoring

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, Davis Medical Center Division of Cardiovascular Medicine

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Surabhi Atreja, MD

Role: CONTACT

(916) 734-2011

Lina Du, BS

Role: CONTACT

Facility Contacts

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Surabhi Atreja, MD

Role: primary

916-734-6082

Other Identifiers

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1972752

Identifier Type: -

Identifier Source: org_study_id

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