Personalized Analytics and Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation (DeCODe)

Objective:

Collect sufficient data to identify a set of predictor variables that most accurately predict a COVID-19 decompensation event aimed at developing and validating a clinically-useful COVID Decompensation Index (CDI).

Description of Study Intervention:

pinpointIQ™ is a continuous remote patient monitoring system intended for use by healthcare professionals for collection of physiological data.  The end-to-end solution consists of the VitalPatch Sensor (a 510k-cleared disposable patch with integrated biosensors and a wireless transceiver) and the physIQ Platform (a mobile application for data transmission, cloud-based information-technology [IT] infrastructure, physiology analytics modules, and clinician user interface).  The patch is worn on the torso for up to 7 days and measures and records physiological variables that can include, but are not limited to, electrocardiography (ECG) waveforms, vital signs and activity.  Data are transmitted wirelessly from the VitalPatch Sensor to the physIQ IT platform for storage and analysis and presentation within the clinician user interface. A watchlist in the user interface displays alerts that represent clinician defined events. Questionnaires provided through the mobile app can also be responded to by the patient and responses viewed in the clinician portal (user interface).

Study Population:

Participants will be adult patients in the University of Illinois Health System (UIH). Participants will be recruited from two pools of patients at UIH: 1) patients tested in the outpatient setting who have a positive result for SARS-Cov-2 (COVID-19) and 2) patients who were admitted to the hospital with a diagnosis of COVID-19 and subsequently discharged to home convalescence. This will be a convenience sample.  Phase 1 will have a sample size of 400 and Phase 2 will have a sample size of 1,200.

Sample Size:

Phase 1: 400 patients
Phase 2: 1200 patient

Description of Sites/Facilities Enrolling Participants: 

University of Illinois at Chicago (UIC), UIH emergency department and 4 associated outpatient clinics.  Also, UIH is comprised of a clinical enterprise that includes a 462-bed tertiary care hospital, outpatient clinics, and Mile Square Health Center locations, which are all Federally Qualified Health Centers (FQHC).

Study Duration:

Phase 1: expected 4 months, Phase 2: expected 6 months

Participant Duration:

28 days