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临床试验/NCT04531254
NCT04531254已完成不适用

Understanding the Impact of Public Health Measures Planned for School Reopening During COVID-19 Using Simulation Exercises

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2020年8月10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
174
试验地点
2
主要终点
Total number of hand-to-face contacts per participant per hour

研究概览

简要总结

This will be a prospective study simulating return to school for two full days prior to the start of the school year in September. Volunteer students and teachers from six grade ranges will be recruited to participate in the study. In each grade range, there will be two classes that will participate, one that will be assigned to wear face masks/coverings at all times (experimental group/class) and the other that will not wear face masks/coverings at all times (control group/class). Students will be randomized to either the masking at all times (experimental across all grades) or no masking (control across JK-Grade 4) / masking only when physical distance can be maintained (control across Grade 5-Grade 12) class in their appropriate grade. Personal behaviours and person-to-person interactions will be recorded using video cameras. In addition, a safe biological indicator will be applied to the hands to simulate potential asymptomatic infection in a subset of students. Other students will have sanitizer applied so that students are blinded to who has the indicator. Cameras will be used to document how the indicator moves throughout the classroom.

详细描述

Grade ranges will include 1) Senior Kindergarten (children who have just completed JK or SK in the 2019-2020 year), 2) Grades 1-2, 3) Grades 3-4, 4) Grades 5-6, 5) Grades 7-8 and 6) high school. A total of 14 teachers and up to 240 students will be recruited. Final class sizes will be in accordance with Ministry of Education and public health guidelines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • To be included in the study, students must have attended a structure learning environment during 2019-2020 school year and provide informed consent (student in Grade 7 or older) or parental consent (SK - Grade 6) and assent (if appropriate). To be included in the study, teachers must be certified teachers and provide informed consent to participate.

排除标准

  • require additional resources or support beyond what can be provided by the single class teacher
  • have been exposed to an individual that has tested positive for COVID-19 in the 14 days prior to the simulation
  • test positive for COVID-19 in the 14 days prior to the simulation
  • have signs or symptoms of COVID-19, as identified on the screening form (See Screening Form) before the simulations
  • travel outside Canada in the last 14 days
  • known hypersensitivity or allergy to the biological indicator (Fluorescein dye/GloGerm)

结局指标

主要结局

Total number of hand-to-face contacts per participant per hour

时间窗: Day 2

The number of touches to the face made per hour in the simulated school environment

次要结局

  • Total number of instances of hand holding per participant per hour(Day 2)
  • Teacher concerns measured using study-specific post-simulation questionnaire(Day 2)
  • Student concerns measured using study-specific post-simulation questionnaire(Day 2)
  • Student concerns measured using semi-structured group interviews(Day 2)
  • Total number of hand-to-non-mucus membrane contacts per participant per hour(Day 2)
  • Total number of instances where participants are within 1 and 2 meters of each other(Day 2)
  • Total number of glo germ transfers to a surface(Day 2)
  • Total number of hand hygiene actions per participant per hour(Day 2)
  • Total number of glo germ transfers to teacher(Day 2)
  • Total number of touches to another person per participant per hour(Day 2)
  • Total number of hand-to-mucus membrane contacts per participant per hour(Day 2)
  • Total number of glo germ transfers to another person(Day 2)
  • Total number of mask removals per participant per hour(Day 2)
  • Teacher concerns measured using semi-structured group interviews(Day 2)
  • Identify activity types that influence touching behaviour(Day 2)

研究者

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

Michelle Science

Infectious Disease Physician

The Hospital for Sick Children

研究点 (2)

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