Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 607
- 试验地点
- 1
- 主要终点
- Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service
研究概览
简要总结
Covid-19, a commonly severe respiratory tract infection caused by the SARS-CoV2 Coronavirus, poses an increasing threat to individual health and health care systems. The individual disease course ranges from mild to life threatening, the pandemic spread leads to a shortage of health care resources including intensive care availability. It should be the overarching goal to allocate sparse health care resources to those most at need and to simultaneously avoid unnecessary blocking of resources by clinically unjustified hospitalizations.
Individuals with preexisting cardiovascular conditions are at the highest risk of health deterioration, even at younger age. Objective criteria for hospitalization are not immediately available in a outpatient settings. Hence, hospitalization and emergency medical contact is often triggered by subjectively interpreted symptoms. The goal of this project is thus to improve the availability of objective measurements in the outpatient setting by means of an innovative, smartwatch mediated telemedicine approach.
To achieve this goal, the investigators will conduct a randomized clinical trial comparing a smartwatch based telemedicine intervention with standard of care. The intervention group will receive regular objective measurements of heart rate, ECG, and SpO2 and will get access to a 24/7 medical care hotline for consultation. The investigators hypothesize that the intervention group will benefit by a significant reduction in unnecessary hospitalizations and unplanned emergency medicine contacts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Confirmed SARS-CoV2 infection and clinical Covid-19 disease
- •age ≥18 years
- •Presence of ≥1 relevan cardiovascular condition, defined as (or):
- •atrial fibrillation
- •systolic or diastolic heart failure
- •LV ejection fraction <50%
- •coronary artery disease with past PCI or CABG
- •Past myocardial infarction
- •diabetes mellitus
- •arterial hypertension (treated or untreated)
- •active smoking
- •chronic obstructive lung disease
- •obesity (BMI ≥30kg/m2)
- •availability of smartphone and sufficient internet connectivity at home
- •ability to use smartwatch
- •informed consent to study participation and data protection concept
排除标准
- •Participation in concurrent clinical trial
- •indication for hospitalization at study entry
研究组 & 干预措施
Telemedicine Care
Patients receive assessment at baseline and at 30 day follow up. Patient receive a smart watch capeable of recording SpO2, ECG, and heart rate. Patients also receive access to 24/7 medical hotline for telemedical care. All public services of the health care system remain available.
干预措施: Withings ScanWatch (Device)
Control
Patients receive assessment at baseline and at 30 day follow up. Patient have access to all services of the health care system, but do not receive a smart watch or medical hotline access.
结局指标
主要结局
Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service
时间窗: 30 days
Occurrence of any of the above during follow-up
次要结局
- Rate of participants hospitalized(30 days)
- Rate of participants with unplanned use of hospital emergency department or emergency medical service(30 days)
- Rate of participants experiencing death of any cause(30 days)
- Rate of participants experiencing death of Covid-19(30 days)
研究者
Moritz F. Sinner
Assistant Professor
Ludwig-Maximilians - University of Munich