Digital Monitoring for Patients Post Coronary Interventions to Reduce Risk for Recurrent Adverse Cardiovascular Events
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LiveCare, Text Messages, Conventional Care.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- blood pressure, systolic and diastolic [Time frame: 1 month, 6 months]
- readmission rate [Time frame: 1 month, 6 months]
- enrollment rate in cardiac rehabilitation [Time frame: 1 month, 6 months]
- rate of non-compliance to medications prescribed at discharge [Time frame: 1 month, 6 months]
- average ratings on the telehealth usability questionnaire [Time frame: six months]
- patient rate of first follow up appointment [Time frame: 1 month, 6 month]
Secondary outcome measures (2)
- lipid profile [Time frame: one month, six months]
- Major adverse cardiovascular events (MACE) [Time frame: one month, six months]
Eligibility criteria
Inclusion criteria
- Includes patients with coronary heart disease diagnosis and treatment with PCI who follow up at University of California Davis Health.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of California, Davis Medical Center Division of Cardiovascular Medicine — Sacramento
Identifiers
NCT: NCT06114615 · 1972752