The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Controlled Blood pressure
研究概览
简要总结
Study to investigate whether a smart technology intervention can improve clinical and cost-effectiveness of one-year follow-up in patients who suffered from acute myocardial infarction.
详细描述
Rationale: Smart technology could improve quality of care in patients after acute myocardial infarction (AMI) with either ST or non-ST elevation.
Objective: The objective of this study is to measure the effect of a smart technology intervention on patients after AMI.
Study design: The design of the study is a single-center, open randomized-controlled trial.
Study population: The study population consists of patients who have been discharged from the ward of the cardiology department of the Leiden University Medical Center after primary percutaneous coronary intervention (PCI) for either ST or non-ST elevation myocardial infarction.
Intervention: Patients will be randomized to either "The Box" or regular follow-up. Patients who have been randomized to The Box will receive a box containing a smartphone compatible electrocardiogram (ECG) monitor, a weight scale, an activity tracker and a blood pressure monitor. If patients are randomized to The Box, two of the four outpatient clinic visits will be replaced by an e-consult, in which a patient does not have to go to the hospital, but talks with his or her doctor or nurse practitioner via a secured video connection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patient is admitted with acute myocardial infarction
- •Patient is able to communicate in English or Dutch at B1 level
排除标准
- •Body Mass Index > 35 kg x m-2
- •Included in another randomized controlled trial
- •Patient is <18 years of age
- •Patient is considered an incapacitated adult
- •Patient is pregnant
- •Patient is unwilling to sign the informed consent form
研究组 & 干预措施
The Box
After randomization, patients in the intervention group will receive a box ("The Box") with all the devices described above. Instructions about the installation and usage of the devices will be given. Patients will be asked to measure their weight and blood pressure once a day. Furthermore, patients will be asked to record an ECG using the AliveCor once a day. Moreover, they are asked to record an ECG in case of any symptoms of possible cardiac origin, as judged by the patient. All data will be automatically transferred to the Leiden University Medical Center. Lastly, two of the four outpatient clinical visits will be done via a video connection. The content of the interview will be comparable to the content of a regular outpatient clinic visit.
干预措施: The Box (Other)
Control
Patients who are randomized to the control group will receive regular care.
结局指标
主要结局
Controlled Blood pressure
时间窗: One year
A blood pressure is considered controlled if the average of three measurements is below 140 (systolic) and 90 (diastolic) after 12 months of follow-up
次要结局
- Patient satisfaction of received care(One year)
- Major adverse cardiac events(One year)
- Percentage of patients in which a previously unknown sustained arrhythmia (30 seconds or more) is detected(One year)
- Physical activity(One year)
- Healthcare utilization(One year)
- Medication-adherence(One year)
- Quality of life(One year)
研究者
RoderickTreskes
BSc
Leiden University Medical Center