Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients

COVID-19 Clinical Trial

— SOY+  

Official title:

Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients With Domiciliary Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802018
• Other study ID #: CASVE-NM-21-508
• Status: Completed
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: December 28, 2022

Study information

• Verified date: February 2023
• Source: Increase-Tech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Spain	Faculty of Medicine of Valladolid	Valladolid

Sponsors (4)

Lead Sponsor	Collaborator
Increase-Tech	Hospital Clínico Universitario de Valladolid, Sanidad de Castilla y León, University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution to severe progression of COVID-19		One month after inclusion of patients in the study
Primary	Need for admission to ICU.		One month after inclusion of patients in the study
Primary	Mortality rate.		One month after inclusion of patients in the study
Secondary	Hospital admission rate		One month after inclusion of patients in the study
Secondary	Delay to hospital admission		One month after inclusion of patients in the study
Secondary	Average hospital stay		One month after inclusion of patients in the study
Secondary	Need for invasive mechanical ventilation		One month after inclusion of patients in the study
Secondary	Occurrence of major vascular events		One month after inclusion of patients in the study
Secondary	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