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. 2023 Jan 28;20(3):2300.
doi: 10.3390/ijerph20032300.

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  1 , María Begoña Coco-Martín  1 , Luis Leal-Vega  1 , Adrián Martín-Gutiérrez  1 , Lidia Peña-de Diego  1 , Carlos Dueñas-Gutiérrez  2 , Flor de Castro-Rodríguez  3 , Pablo Royuela-Ruiz  4 , Juan F Arenillas-Lara  1   5
Affiliations

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 et al. Int J Environ Res Public Health. .

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: Big Data; COVID-19; artificial intelligence; decision support system; mobile health; monitoring; telemedicine; wearable.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Symptoms and associated clinical questions covered by the ‘‘Home app’’.
Figure 2
Figure 2
Decision tree for the generation of moderate or severe alerts based on vital signs monitored in patients allocated to the active group of the study.
Figure 3
Figure 3
Clinical decision support system overview diagram.
See this image and copyright information in PMC

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