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BACKGROUND Monitoring vital signs such as oximetry, blood pressure and heart rate is important to follow the evolution of patients. Smartwatches are a revolution in medicine, allowing the collection of such data in a continuous and organic way. However, it is still a challenge to make this information available to healthcare professionals in clinical follow-up to make decisions. OBJECTIVE Build a digital solution that displays vital signs data from smartwatches, collected remotely, continuously, reliably and from multiple users, with trigger warnings when abnormal results are identified. METHODS This is a single-centre prospective study following the guidelines “Evaluating digital health products” from UK Health Security Agency. A digital platform was built following information security standards. 80 volunteers were selected for this clinical trial and followed by 24 weeks each and divided in two groups, one with previous diagnosis of Covid-19, and a control groups without previous diagnosis Covid-19. Synchronization rate with the platform, accuracy and precision of the equipment under domestic conditions were evaluated to simulate remote home monitoring. RESULTS In 35 weeks of clinical study, more than 11.2 million records have been collected, without system downtimes. 66% of continuous beats per minute were synchronized within 24 hours (79% within 2 days; 91% within a week). At LoA analysis, the mean difference of oxygen saturation, diastolic BP, systolic BP and heart rate were respectively: -1.280 (±5.679) %, -1.399 (±19.112) mmHg, -1.536 (±24.244) mmHg, 0.566 (±3.114) bpm. The user experience shows that 69% of volunteers agreed that feel like the smartwatch is embedded in their body. Finally, there was no difference in the two groups of study regarding the data analysis (neither using the smartwatch nor the gold-standard devices), but it should be noted that all volunteers from the Covid-19 group were already been cured from the infection and highly functional at their daily work life. CONCLUSIONS Based on the observed results and the synchronization reliability, the proposed solution (smart watch + digital platform) provides clinically relevant data to support medical decision during remote monitoring of outpatients in real life (free-living conditions) and non-urgent scenarios. This study indicates that there is a wide acceptance/adherence for the use of the smart watch, which may allow us to suggest and consider this solution as a suitable tool to follow chronic disease patients. CLINICALTRIAL This project was submitted to the Ethics and Research Committee of the Hospital das Clinicas, The Faculdade de Medicina of University of São Paulo under number CAAE: 51711921.3.0000.0068 and Opinion number: 4,975,512. |
