Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients With Domiciliary Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Mortality rate.
研究概览
简要总结
The aim of the study is to provide clinical decision support to healthcare professionals using a wearable for non-invasive multimodal monitoring, allowing early detection of disease progression to severe forms, as well as the detection of significant clinical events.
For the development of the study, 500 individuals with COVID-19 in home confinement will be randomly assigned to form part of the control group, which will be followed conventionally by Primary Care Professionals, or to the experimental group, which will also be provided with the wearable device for non-invasive multimodal monitoring linked to an App for transfering data. Furthermore, the patient will be able to interact with the application on three times daily by indicating the symptoms contemplated and answering the decision clinical questions. In this way, alarms can be generated in the presence of symptoms or significant alterations in the parameters monitored by the device, which the health professionals of the Primary Care teams included in the study will evaluate at the appropriate time, taking the best decision in each case.
详细描述
As variables to be considered in order to compare the effectiveness of the system against the conventional monitoring protocol, complemented with real-time patient notification of symptoms, certain variables will be collected, such as:
Baseline variables:
- Age, sex, date of COVID-19 positive diagnosis (PCR or antigen test).
- Stage of clinical progression of the disease: according to the Primary Care COVID-19 management
- Information collected in the telephone clinical assessment questionnaire in the home follow-up of the patient with SARS-CoV-2 infection
Variables generated by the study follow-up:
- Vital signs covered by the Bakeey E66 smartwatch device: temperature, respiration rate (RR), heart rate (HR) and oxygen saturation (SatO2)
- Clinical symptoms covered by the Home App for submission by the patient: cough, fever, chest pain, respiratory distress (dyspnoea), vomiting and diarrhoea.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of SARS-CoV-2 disease, detected by PCR or antigen test, performed 72 h prior to patient inclusion in the study.
- •Acceptance to sign the informed consent document.
- •Possession of a Smartphone or Tablet with Internet connection.
- •Possession of mental faculties to participate in the study.
排除标准
- •Age below the age of health majority (16 years).
- •Lack of digital skills to use the Home App.
- •Cognitive impairment that prevents the patient from participating in the study.
- •Disabling pathology of the upper limb.
结局指标
主要结局
Mortality rate.
时间窗: One month after inclusion of patients in the study
Evolution to severe progression of COVID-19
时间窗: One month after inclusion of patients in the study
Need for admission to ICU.
时间窗: One month after inclusion of patients in the study
次要结局
- Economic cost of the care derived from the episode for the social and health care system.(One month after inclusion of patients in the study)
- Hospital admission rate(One month after inclusion of patients in the study)
- Average hospital stay(One month after inclusion of patients in the study)
- Occurrence of major vascular events(One month after inclusion of patients in the study)
- Need for invasive mechanical ventilation(One month after inclusion of patients in the study)
- Delay to hospital admission(One month after inclusion of patients in the study)
研究者
Juan Francisco Arenillas Lara
Phd, physician
Increase-Tech