Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients (SOY+)

Increase-Tech

Status

Completed

Conditions

COVID-19

Treatments

Device: Clinical decision support system based on non-invasive multimodal monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT04802018

CASVE-NM-21-508

Details and patient eligibility

About

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.

Full description

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.

Enrollment

300 patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria