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临床试验/NCT05312619
NCT05312619Unknown不适用

The Burden of Lyme Disease (BOLD) in a Pandemic

Dr. Daniel Cameron & Associates1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年7月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30)

研究概览

简要总结

A cross-sectional descriptive survey of the BOLD for individuals after having been ill with COVID-19 or have taken the COVID-19 vaccine will be compared with that of individuals who have neither been ill with COVID-19 nor taken the COVID-19 vaccine. Individuals who have both been ill and taken the COVID-19 vaccine will be compared to identify any additive risk factors.

详细描述

Primary research question:

  1. Will the BOLD be worse for individuals who have taken the COVID-19 vaccine?

Secondary research questions:

  1. Will the BOLD be worse for individuals who have been ill with COVID-19?
  2. What factors affect the BOLD in individuals a) after having been ill with COVID-19, and b) in those who have taken the COVID-19 vaccine? Do they differ?
  3. If BOLD risk factors specific to either the COVID-19 vaccine or having been ill with COVID-19 are found, are they additive in people who have experienced both?
  4. What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine?
  5. What is the severity of symptoms most likely to predict functional problems in individuals with Lyme disease who have been ill with COVID-19 or taken the COVID-19 vaccine?

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥12 years old
  • a self-report of having been diagnosed with Lyme disease.

排除标准

  • There are no exclusion criteria.

结局指标

主要结局

Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30)

时间窗: 7/21 to 7/23

Cross sectional

次要结局

未报告次要终点

研究者

发起方
Dr. Daniel Cameron & Associates
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Cameron

Chief Investigator

Dr. Daniel Cameron & Associates

研究点 (1)

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