Covid19
Conditions
Brief summary
In this study we will be monitoring for patient events (emergency department admission, hospital admission, admission to an observation unit, or death) and evaluating the feasibility and utility of using pinpointIQ in the management of patients with COVID-19. Vital sign (physiology data) is collected to build a Covid Decompensation Index and contribute data to a Covid Digital Hub supported by the National Institutes of Health.
Detailed description
This is a prospective, non-randomized, open-label, two-phase design. The primary focus for the study is data collection for index development. This will be done in two phases: the first phase allows for determination of predictor variables that establish the COVID-19 Decompensation Index (CDI) and the second phase establishes performance of the CDI. A participant is considered to have completed the study if he or she completes all phases of the study including the last day of monitoring (day 28).
Interventions
DEVICEUse of the pinpointIQ solution (physIQ, Inc.)
Patients are monitored for 28 days post COVID19 diagnosis or COVID19 post-hospitalization discharge using the pinpointIQ solution.
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Cancer Institute (NCI)
University of Illinois at Chicago
physIQ, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Obtained signed and dated informed consent form Patient in the University of Illinois Health System Patient agrees to comply with all study procedures and availability for the duration of the study Male or female, aged \> 18 years of age Patient diagnosed with COVID-19 (positive SARS CoV2 test) Patient agrees to refrain from swimming or taking baths (any activity that submerges the biosensor in water for any period). Showering is okay.
Exclusion criteria
Known allergic reactions to components of the hydrocolloid gel adhesives Subject has cognitive or physical limitations that, in the opinion of the investigator, limits the subject's ability to fully follow study procedures Cognitive ability, in the opinion of the investigator, that limits the patient's ability to use the biosensor and smartphone consistent with study requirements. Does not speak or read English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of Covid Decompensation Index | 4 months | To 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 4 months | To evaluate the feasibility of using the pinpointIQ solution as a tool for healthcare professionals to identify physiologic decompensation and manage the study populations based on physIQ validated rule sets and analytics. |
Countries
United States
Outcome results
None listed