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| Name | Class |
|---|---|
| Hospital ClÃnico Universitario de Valladolid | OTHER |
| University of Valladolid | OTHER |
| Sanidad de Castilla y León | OTHER |
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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.
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:
Variables generated by the study follow-up:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitored group | Experimental | Monitoring of vital signs and following with the conventional telephone protocol |
|
| Control group | No Intervention | Conventional telephone follow-up by health staff |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Francisco Arenillas Lara, PhD | Study Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine of Valladolid | Valladolid | 47015 | Spain |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Single-blind, controlled, randomised clinical trial
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| 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 |
| Economic cost of the care derived from the episode for the social and health care system. | One month after inclusion of patients in the study |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |