Coronary Artery Disease
Conditions
Keywords
post-PCI, digital monitoring, cardiac rehabilitation
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.
Interventions
DEVICELiveCare
Patient use LiveCare device to monitor their blood pressure and data is transmitted to dashboard.
BEHAVIORALText Messages
Patients also receive text messages after their PCI procedure for follow up appointment reminders, enrollment in cardiac rehab, and diet and exercise counseling.
OTHERConventional Care
No digital monitoring with LiveCare device and no text messages.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Includes patients with coronary heart disease diagnosis and treatment with PCI who follow up at University of California Davis Health.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure, systolic and diastolic | 1 month, 6 months | — |
| 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 | — |
| 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 |
| patient rate of first follow up appointment | 1 month, 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| lipid profile | one month, six months |
| Major adverse cardiovascular events (MACE) | one month, six months |
Countries
United States
Contacts
CONTACTSurabhi Atreja, MD
CONTACTLina Du, BS
Outcome results
None listed