Digital Monitoring for Patients Post Coronary Interventions to Reduce Risk for Recurrent Adverse Cardiovascular Events
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- blood pressure, systolic and diastolic
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Includes patients with coronary heart disease diagnosis and treatment with PCI who follow up at University of California Davis Health.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: LiveCare (Device)
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.
干预措施: Text Messages (Behavioral)
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.
干预措施: Conventional Care (Other)
结局指标
主要结局
blood pressure, systolic and diastolic
时间窗: 1 month, 6 months
patient rate of first follow up appointment
时间窗: 1 month, 6 month
average ratings on the telehealth usability questionnaire
时间窗: 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
readmission rate
时间窗: 1 month, 6 months
enrollment rate in cardiac rehabilitation
时间窗: 1 month, 6 months
rate of non-compliance to medications prescribed at discharge
时间窗: 1 month, 6 months
次要结局
- Major adverse cardiovascular events (MACE)(one month, six months)
- lipid profile(one month, six months)