JMIR Publications

ABSTRACT

Background:

Vital signs monitoring such as oximetry, blood pressure and heart rate are important to follow-up the evolution of patients, alerting the need for clinical intervention and adjustments in the therapeutic process, avoiding worsening of the clinical picture, new hospitalizations and the expansion of the disabling condition. And the possibility of measuring continuously and naturally through wearable devices, such as smart watches, is a revolution in medicine through mobile health (m-health) and digital health (e-health).

Objective:

Build a digital solution that captures vital signs data from smart watches in a continuous, secure and reliable way.

Methods:

This is a single-centre prospective study following the guidelines “Evaluating digital health products” from UK Health Security Agency. A digital solution was created to capture and display data from mobile phone of the volunteers with the smartwatches. 80 volunteers were selected for this clinical trial, divided by the previous diagnosis of Covid-19 in two groups, and are followed by 24 weeks each.

Results:

In 14 weeks of project progress, we managed to recruit 80 volunteers, with 68 already registered in the digital solution. More than 2.8 million records have already been collected.

Conclusions:

The digital solution is working properly in its role of collecting data from the smart watches of research volunteers. Vital sign values are being monitored by the research team as part of monitoring the health of volunteers. Accuracy and reliability studies still need to be performed at the end of the 24-week follow-up of volunteers. Clinical Trial: This project was submitted to the Ethics and Research Committee of the Hospital das Clínicas, Faculty of Medicine, University of São Paulo under number CAAE: 51711921.3.0000.0068 and Opinion No. 4,975,512. Its opinion was approved on September 15, 2021 without the need for consideration by CONEP.