Detection of COVID-19 Decompensation
DeCODe
Personalized Analytics and Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation
2 other identifiers
observational
1,000
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedStudy Start
First participant enrolled
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2021
CompletedSeptember 13, 2021
May 1, 2021
11 months
October 1, 2020
September 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Development of Covid Decompensation Index
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).
4 months
Secondary Outcomes (1)
Feasibility
4 months
Interventions
Patients are monitored for 28 days post COVID19 diagnosis or COVID19 post-hospitalization discharge using the pinpointIQ solution.
Eligibility Criteria
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 SAR-Co-V2 (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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- physIQ, Inc.lead
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)collaborator
- National Cancer Institute (NCI)collaborator
- University of Illinois at Chicagocollaborator
Study Sites (4)
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612, United States
NorthShore University HealthSystem
Evanston, Illinois, 60210, United States
University of Texas Health
Houston, Texas, 77004, United States
Related Publications (1)
Larimer K, Wegerich S, Splan J, Chestek D, Prendergast H, Vanden Hoek T. Personalized Analytics and a Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation (DeCODe): Protocol for the Development of the COVID-19 Decompensation Index. JMIR Res Protoc. 2021 May 26;10(5):e27271. doi: 10.2196/27271.
PMID: 33949966DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Larimer, PhD
physIQ, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2020
First Posted
October 5, 2020
Study Start
October 5, 2020
Primary Completion
September 9, 2021
Study Completion
September 9, 2021
Last Updated
September 13, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- January 2021
- Access Criteria
- NIH is gate keeper of data access through the digital hub
This effort is part of a hub-and-spoke technology implementation model created by the NIH, in which each supported digital health solution (the spokes) will be required to share deidentified data and other digital assets it generates with an NIH-supported central data hub. The data hub will provide global researchers a single access point to deidentified data, algorithms, and other capabilities generated by the various digital health solutions. Standards that enhance interoperability will enable unambiguous linking of digital resources among the spokes of the hub. This will enable researchers, for example, to apply the CDI developed in this project's spoke to individuals' health data that was collected by other spokes.