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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
300
Non-invasive multimodal vital signs monitoring with the wearabl to monitor for a period of 10 days after the date of positive diagnosis to COVID-19. The device will be linked to the Home App, which will allow the sending of temperature, HR and RR data to the server every 15 minutes a day and the notification of symptoms by the patient three times a day.
Faculty of Medicine of Valladolid
Valladolid, Spain
Evolution to severe progression of COVID-19
Time frame: One month after inclusion of patients in the study
Need for admission to ICU.
Time frame: One month after inclusion of patients in the study
Mortality rate.
Time frame: One month after inclusion of patients in the study
Hospital admission rate
Time frame: One month after inclusion of patients in the study
Delay to hospital admission
Time frame: One month after inclusion of patients in the study
Average hospital stay
Time frame: One month after inclusion of patients in the study
Need for invasive mechanical ventilation
Time frame: One month after inclusion of patients in the study
Occurrence of major vascular events
Time frame: One month after inclusion of patients in the study
Economic cost of the care derived from the episode for the social and health care system.
Time frame: One month after inclusion of patients in the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.