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

NCT04802018 | Completed DMC

• 1 other identifier: CASVE-NM-21-508
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Telemedicine; COVID-19; wearable device; e-Health; Remote monitoring

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (2)

Monitored group

EXPERIMENTAL

Monitoring of vital signs and following with the conventional telephone protocol

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

Control group

NO INTERVENTION

Conventional telephone follow-up by health staff

Interventions

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

Monitored group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Increase-Tech: lead
• Hospital Clínico Universitario de Valladolid: collaborator
• University of Valladolid: collaborator
• Sanidad de Castilla y León: collaborator

Study Sites (1)

Faculty of Medicine of Valladolid

Valladolid, 47015, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Juan Francisco Arenillas Lara, PhD

  Study Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, physician

Model Details: Single-blind, controlled, randomised clinical trial

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 17, 2021
• Study Start: March 9, 2021
• Primary Completion: September 28, 2022
• Study Completion: December 28, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)