Digital Long-term Follow-up of Patients With Coronary Artery Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 630
- 试验地点
- 2
- 主要终点
- The proportion of patients fulfilling all of the following evidence-based goals for risk factor control at 1 year follow-up: 1) BP< 130/80 mmHg, 2) LDL-cholesterol <1.4 mmol/l, 3) HbA1c<53 mmol/mol, and 4) No smoking.
研究概览
简要总结
The need for better follow-up of AMI patients combined with recent developments in the digital area prompted the Department of Cardiology (HJE) at Oslo University Hospital (OUS) Ullevål, in collaboration with the Department of Digital Health Research (DIG) at OUS to develop a digital solution for long-term follow-up after AMI. The overall goal of the digital solution is to increase knowledge and awareness about important lifestyle measures and CV risk factors in patients who have survived an AMI, and to make it easy for the patients to monitor their own risk factors and attainment of treatment goals during long-term follow-up. Further, the HeartCheck seeks to provide guidance to ensure medication adherence. In this project, we study whether this newly developed app (HeartCheck), through education, regular reminders and easily understandable goals for secondary prevention, can improve risk factor control and drug adherence during long-term follow-up after AMI. A randomized controlled trial (RCT) is the chosen study design, being the gold standard for testing effectiveness of interventions.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •survived a recent (<30 days) AMI and/or PCI
- •access to a smartphone or tablet
- •signed written informed consent
排除标准
- •patient does not understand Norwegian
- •patient is unable to comply with the study procedures due to severe comorbidities or high age
研究组 & 干预措施
Usual care
Patients are offered standard followed up by their hospital and GP
Use of a digital application for follow-up
Use of the application "Heart-Check" developed by the researchers
干预措施: "HeartCheck" (Device)
结局指标
主要结局
The proportion of patients fulfilling all of the following evidence-based goals for risk factor control at 1 year follow-up: 1) BP< 130/80 mmHg, 2) LDL-cholesterol <1.4 mmol/l, 3) HbA1c<53 mmol/mol, and 4) No smoking.
时间窗: 12 months after inclusion in the study
Proportion of patients fulfilling 4 evidence-based goals for risk factor control
时间窗: 12 months after inclusion in the study
Proportion of patients who fulfills all of the following: 1) BP \<130/80 mmHg, 2) LDL-cholesterol \<1.4 mmol/l, 3) HbA1c \<53mmol/mol, 4) No smoking
次要结局
未报告次要终点
研究者
Sigrun Halvorsen
Professor
Oslo University Hospital