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临床试验/NCT04766788
NCT04766788已完成不适用

Monitoring Beliefs and Physiological Measures in Students at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology

University of Michigan1 个研究点 分布在 1 个国家目标入组 2,381 人开始时间: 2020年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,381
试验地点
1
主要终点
Feasibility of wearing Fitbit device

研究概览

简要总结

The goal of this longitudinal observational study is to learn about how the COVID-19 has impacted and continues to impact students at the University of Michigan. We hope to determine whether a combination of (1) continuous heart rate obtained from wearable devices, (2) self-reported data from surveys and symptom logs, and (3) saliva samples can be used to help students self-monitor for infection and eventually be able to create a predictive model to detect illness early.

详细描述

The study was originally intended to last one year, however, it was expanded to follow the study participants over several years.

During this study, participants will be asked to:

  • Provide a baseline self-collected saliva sample
  • Download and use a suite of mobile apps (e.g., Fitbit, Social Rhythms, Roadmap 2.0)
  • Complete surveys online
  • Wear non-invasive Fitbit smartwatch
  • Grant the study team access to their university academic records (optional)

The study will use these tools to monitor participants' physical activity and mental health over the course of at least three years. The study will also examine whether there is a connection between mental health and academic performance.

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

入选标准

  • Students at the University of Michigan who have moved back to Ann Arbor or who are completing schooling completely online.
  • For those completing school online, must be able to provide a mailing address within the United States where they can receive study tools
  • Possession of a smartphone (Apple or Andriod)
  • Ability to understand and demonstrate willingness to sign a written informed consent.

排除标准

  • Unwilling or unable to comply with the study procedures.

结局指标

主要结局

Feasibility of wearing Fitbit device

时间窗: 4 months

Feasibility will will be defined as wearing the Fitbit watch at least 8 hours per day up to at least 5 days of the week

次要结局

  • Saliva sample(Up to 4 months)
  • Survey completion(Up to 9 months)
  • Mental well-being(Up to 9 months)
  • Continuous heart rate(Up to 8 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sung Won Choi

Edith S Briskin and Shirley K Schlafer Foundation Research Professor of Pediatrics and Associate Professor of Pediatrics and Communicable Diseases

University of Michigan

研究点 (1)

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