Covid19 Clinical Trial - Clinical Decision Support System Based on

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

COVID-19

Clinical Trial Details

NCT number	NCT04802018
Study type	Interventional
Source	Increase-Tech
Contact
Status	Completed
Phase	N/A
Start date	March 9, 2021
Completion date	December 28, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms