This pilot study aims to investigate the feasibility of using Hexoskin cardiorespiratory and activity data, as well as patient symptomatology, to provide an AI model for disease progression that will be at the service of the clinical team to recommend the best customized and evolving care trajectory for each patient.
The following protocol proposes a mixed methods pilot study, whereby the immediate purpose is to generate quantifiable information regarding the feasibility of a virtual trial with the Hexoskin Platform, collection of data quality in COVID-19 patients, and values for algorithm construction. In essence, sixteen participants with a confirmed COVID-19 diagnosis will be invited to wear the Hexoskin biometric garment during the course of several hours per week, over a period of 28 days. In addition to the biometric data collection, participants will be invited to complete four questionnaires. The biometric data will be combined to the sociodemographic information and patient symptomatology to construct an algorithm which can accurately predict patient outcomes.
Study Type
OBSERVATIONAL
Participants will be monitored using a validated biometric garment (Hexoskin smart shirt). Cardiorespiratory and activity data will be collected over a 28-day monitoring period. Participants will be invited to wear the shirt during the day and at night.
Qualitative assessment of the feasibility of the Hexoskin Platform and Virtual Recruitment Process via three subjective feedback questionnaires provided to all patients enrolled in the study.
Evaluating the feasibility of a virtual trial to collect physiological data with the Hexoskin Platform.
Time frame: Up to six months
Ensure the collection of high-quality data during wake and sleep activities, registered as overall > 90% good quality cardiac data and overall > 90% good quality respiratory data per recording.
Assessing the quality of the data collected with Hexoskin with the Hexoskin quality assessment channels from patients recruited during a virtual trial.
Time frame: Up to six months
Ensure adequate patient compliance, qualified as > 75% of total recording hours completed, and > 75% of daily questionnaires completed.
Determine the participant's level of compliance with study procedures of the research protocol.
Time frame: Up to six months
Investigate the predictive power of Hexoskin physiological data, patient information and symptoms information to correctly classify patient disease progression quantified as the area under the receiver operator characteristics curve (AUC ROC > 0.70).
Assessing the feasibility to use the data collected to build a predictive algorithm for the Hexoskin Remote Monitoring Platform.
Time frame: Up to six months
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