Personalized Analytics and Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- physIQ, Inc.
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Development of Covid Decompensation Index
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Development of Covid Decompensation Index
时间窗: 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).
次要结局
- Feasibility(4 months)