Randomized Controlled Trial Evaluating the Benefit of a Novel Clinical Decision Support System for the Management of COVID-19 Patients in Home Quarantine: A Study Protocol

Irene Alcoceba-Herrero, María Begoña Coco-Martín (), Luis Leal-Vega, Adrián Martín-Gutiérrez, Lidia Peña- de Diego, Carlos Dueñas-Gutiérrez, Flor de Castro-Rodríguez, Pablo Royuela-Ruiz and Juan F. Arenillas-Lara
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Irene Alcoceba-Herrero: Group of Applied Clinical Neurosciences and Advanced Data Analysis, Department of Medicine, Dermatology and Toxicology, University of Valladolid, 47005 Valladolid, Spain
María Begoña Coco-Martín: Group of Applied Clinical Neurosciences and Advanced Data Analysis, Department of Medicine, Dermatology and Toxicology, University of Valladolid, 47005 Valladolid, Spain
Luis Leal-Vega: Group of Applied Clinical Neurosciences and Advanced Data Analysis, Department of Medicine, Dermatology and Toxicology, University of Valladolid, 47005 Valladolid, Spain
Adrián Martín-Gutiérrez: Group of Applied Clinical Neurosciences and Advanced Data Analysis, Department of Medicine, Dermatology and Toxicology, University of Valladolid, 47005 Valladolid, Spain
Lidia Peña- de Diego: Group of Applied Clinical Neurosciences and Advanced Data Analysis, Department of Medicine, Dermatology and Toxicology, University of Valladolid, 47005 Valladolid, Spain
Carlos Dueñas-Gutiérrez: COVID-19 Unit, Department of Internal Medicine, University Clinical Hospital of Valladolid, 47003 Valladolid, Spain
Flor de Castro-Rodríguez: Emergency Medical Services (SEM) Direction, Sacyl, 47006 Valladolid, Spain
Pablo Royuela-Ruiz: Technical Direction of Primary Care, Sacyl, 47007 Valladolid, Spain
Juan F. Arenillas-Lara: Group of Applied Clinical Neurosciences and Advanced Data Analysis, Department of Medicine, Dermatology and Toxicology, University of Valladolid, 47005 Valladolid, Spain

IJERPH, 2023, vol. 20, issue 3, 1-13

Abstract: (1) Background: We present the protocol of a randomized controlled trial designed to evaluate the benefit of a novel clinical decision support system for the management of patients with COVID-19. (2) Methods: The study will recruit up to 500 participants (250 cases and 250 controls). Both groups will receive the conventional telephone follow-up protocol by primary care and will also be provided with access to a mobile application, in which they will be able to report their symptoms three times a day. In addition, patients in the active group will receive a wearable smartwatch and a pulse oximeter at home for real-time monitoring. The measured data will be visualized by primary care and emergency health service professionals, allowing them to detect in real time the progression and complications of the disease in order to promote early therapeutic interventions based on their clinical judgement. (3) Results: Ethical approval for this study was obtained from the Drug Research Ethics Committee of the Valladolid East Health Area (CASVE-NM-21-516). The results obtained from this study will form part of the thesis of two PhD students and will be disseminated through publication in a peer-reviewed journal. (4) Conclusions: The implementation of this telemonitoring system can be extrapolated to patients with other similar diseases, such as chronic diseases, with a high prevalence and need for close monitoring.

Keywords: COVID-19; decision support system; Big Data; artificial intelligence; mobile health; telemedicine; wearable; monitoring (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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