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

Int J Environ Res Public Health. 2023 Jan 28;20(3):2300. doi: 10.3390/ijerph20032300.

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.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19*
  • Decision Support Systems, Clinical*
  • Humans
  • Patients
  • Quarantine
  • Randomized Controlled Trials as Topic
  • SARS-CoV-2

Grants and funding

This study is part of the project “Multimodal Sensorics, AI & Big Data for the control of COVID-19”, funded by the Junta de Castilla y León to the University of Valladolid (UVa) under the COVID-19 fund of the Instituto de Salud Carlos III (Ref.: COV20/00539). The funders had no role in the design of the study; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.