Clinical trial NCT04802018: Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients
Official title: Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients With Domiciliary Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Telemedicine
COVID-19
wearable device
e-Health
Remote monitoring
Lead sponsor: Increase-Tech
Sponsor class: OTHER
Collaborators: name: Hospital Clínico Universitario de Valladolid
name: University of Valladolid
name: Sanidad de Castilla y León
First posted: 2021-03-17
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, controlled, randomised clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Evolution to severe progression of COVID-19
timeFrame: One month after inclusion of patients in the study
measure: Need for admission to ICU.
timeFrame: One month after inclusion of patients in the study
measure: Mortality rate.
timeFrame: One month after inclusion of patients in the study
Secondary outcomes:
measure: Hospital admission rate
timeFrame: One month after inclusion of patients in the study
measure: Delay to hospital admission
timeFrame: One month after inclusion of patients in the study
measure: Average hospital stay
timeFrame: One month after inclusion of patients in the study
measure: Need for invasive mechanical ventilation
timeFrame: One month after inclusion of patients in the study
measure: Occurrence of major vascular events
timeFrame: One month after inclusion of patients in the study
measure: Economic cost of the care derived from the episode for the social and health care system.
timeFrame: One month after inclusion of patients in the study
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Faculty of Medicine of Valladolid
Study officials:
affiliation: Study Director
name: Juan Francisco Arenillas Lara, PhD
role: PRINCIPAL_INVESTIGATOR
References: