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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Device: Clinical decision support system based on non-invasive multimodal monitoring

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47015
    • Faculty of Medicine of Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monitored group; Monitoring of vital signs and following with the conventional telephone protocol	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.
No Intervention: Control group; Conventional telephone follow-up by health staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evolution to severe progression of COVID-19	One month after inclusion of patients in the study
Need for admission to ICU.	One month after inclusion of patients in the study
Mortality rate.	One month after inclusion of patients in the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital admission rate	One month after inclusion of patients in the study
Delay to hospital admission	One month after inclusion of patients in the study
Average hospital stay	One month after inclusion of patients in the study
Need for invasive mechanical ventilation	One month after inclusion of patients in the study
Occurrence of major vascular events	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.	One month after inclusion of patients in the study

Collaborators and Investigators

• Sponsor: Increase-Tech
• Collaborators: University of Valladolid; Hospital Clínico Universitario de Valladolid; Sanidad de Castilla y León

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): December 28, 2022

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; COVID-19; Remote monitoring; wearable device; e-Health
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CASVE-NM-21-508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No