The Impact of Mobile Application and a Digital Support System on the Prevention of Cardiovascular Events in Patients After a Myocardial Infarction.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cardiovascular risk factors control - body mass
研究概览
简要总结
The treatment of acute myocardial infarction (MI) in Poland is at the level of standardized European care. However, the first months after MI are crucial from the perspective of patient's prognosis. It is extremely important to take care of all cardiovascular risk factors.
Mobile application (afterAMI) supported by web system is a novel telemedical tool created to support patient and physician during the process of cardiac rehabilitation. The application has educational model with focus on cardiovascular risk factors and lifestyle after MI. Moreover, there is a module to control vital signs like blood pressure, heart rate, weight and many others. Additionally, application will send reminders for better drug adherence.
100 patients will be recruited to take part in the study. All of which will be hospitalized at the 1st Department and Clinic of Cardiology because of the MI. The aim of the project is to study the impact of application-supported model of care with comparison to standard care. At the end of the study cardiovascular risk factors control will be analysed, as well as rehospitalizations, patient's knowledge regarding risk factors, return to work and quality of life.
This will be a prospective, open-label, randomized, single-centre study. All 100 patients will be observed 6 months after discharge from the hospital. End points will be assessed during control visit 1- and 6-months after inclusion into the study.
This project is an example of a telemedicine solution application into everyday practice, which is consistent with multiple international cardiac societies.
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
- •signing the informed consent to participate in the study
- •hospitalization due to myocardial infarction
- •a mobile device with Internet access and the Android/iOS operating system
- •age >17 years old
- •positive results of the test verifying the basic skills of using mobile applications
排除标准
- 未提供
结局指标
主要结局
Cardiovascular risk factors control - body mass
时间窗: This outcome will be assessed 6 months after discharge from the hospital.
Body mass will be measured. Change \[kg\] from baseline body mass will be analyzed.
Cardiovascular risk factors control - hypertension
时间窗: This outcome will be assessed 6 months after discharge from the hospital.
Systolic and diastolic blood pressure values will be analyzed with special focus on meeting the values recommended by European Society of Cardiology guidelines.
Cardiovascular risk factors control - nicotinism
时间窗: This outcome will be assessed 6 months after discharge from the hospital.
The number of patients who are active smokers will be assessed. The change from baseline will be analyzed.
Rehospitalization or urgent outpatient visit
时间窗: This outcome will be assessed 6 months after discharge from the hospital.
The number and reasons of rehospitalizations and urgent outpatient visits.
Cardiovascular risk factors control - dyslipidemia
时间窗: This outcome will be assessed 6 months after discharge from the hospital.
LDL cholesterol level will be measured and the change from baseline will be analyzed.
次要结局
- Return to work(This outcome will be assessed 6 months after discharge from the hospital.)
- Quality of life - descriptive profile of a respondent's health state(This outcome will be assessed 6 months after discharge from the hospital.)
- Quality of life - MacNew(This outcome will be assessed 6 months after discharge from the hospital.)
- DASS 21 - Depression, anxiety and stress assessment(This outcome will be assessed 6 months after discharge from the hospital.)
- Cardiovascular risk factor knowledge(This outcome will be assessed 6 months after discharge from the hospital.)