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NCT Number: NCT04802018

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine of Valladolid

Valladolid, 47015, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Evolution to severe progression of COVID-19

    Time frame: One month after inclusion of patients in the study

  2. Need for admission to ICU.

    Time frame: One month after inclusion of patients in the study

  3. Mortality rate.

    Time frame: One month after inclusion of patients in the study

Secondary outcomes

  1. Hospital admission rate

    Time frame: One month after inclusion of patients in the study

  2. Delay to hospital admission

    Time frame: One month after inclusion of patients in the study

  3. Average hospital stay

    Time frame: One month after inclusion of patients in the study

  4. Need for invasive mechanical ventilation

    Time frame: One month after inclusion of patients in the study

  5. Occurrence of major vascular events

    Time frame: One month after inclusion of patients in the study

  6. Economic cost of the care derived from the episode for the social and health care system.

    Time frame: One month after inclusion of patients in the study

Sponsors and collaborators

Lead sponsor

Increase-Tech

Other

Collaborators

  • Hospital Clínico Universitario de Valladolid
  • Sanidad de Castilla y León
  • University of Valladolid

Registry information

Official study title

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

Acronym: SOY+

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2021
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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