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

NCT ID: NCT04802018

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2022-12-28

Brief 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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Monitored group

Monitoring of vital signs and following with the conventional telephone protocol

Group Type: EXPERIMENTAL

Clinical decision support system based on non-invasive multimodal monitoring

Intervention Type: DEVICE

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.

Control group

Conventional telephone follow-up by health staff

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role: collaborator

University of Valladolid

OTHER

Sponsor Role: collaborator

Sanidad de Castilla y León

OTHER

Sponsor Role: collaborator

Increase-Tech

OTHER

Sponsor Role: lead

Responsible Party

Juan Francisco Arenillas Lara

Phd, physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Francisco Arenillas Lara, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Director

Locations

Faculty of Medicine of Valladolid

Valladolid, , Spain

Countries

Spain

Other Identifiers

CASVE-NM-21-508

Identifier Type: -

Identifier Source: org_study_id