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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство LiveCare
  Patient use LiveCare device to monitor their blood pressure and data is transmitted to dashboard.
• Поведенческое 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.
• Другое Conventional Care
  No digital monitoring with LiveCare device and no text messages.

Первичные конечные точки

• blood pressure, systolic and diastolic [Срок оценки: 1 month, 6 months]
• readmission rate [Срок оценки: 1 month, 6 months]
• enrollment rate in cardiac rehabilitation [Срок оценки: 1 month, 6 months]
• rate of non-compliance to medications prescribed at discharge [Срок оценки: 1 month, 6 months]
• average ratings on the telehealth usability questionnaire [Срок оценки: six months]
• patient rate of first follow up appointment [Срок оценки: 1 month, 6 month]

Вторичные конечные точки (2)

• lipid profile [Срок оценки: one month, six months]
• Major adverse cardiovascular events (MACE) [Срок оценки: one month, six months]

Критерии участия

Критерии включения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of California, Davis Medical Center Division of Cardiovascular Medicine — Sacramento

Идентификаторы

NCT: NCT06114615 · 1972752

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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