COV-IDD: Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 2
- 主要终点
- Number Infected With COVID-19
研究概览
简要总结
The purpose of this study is to understand how to prevent COVID-19 spread in a school like the Mary Cariola Center (MCC) in Rochester, NY by answering questions like these: how do activities in the school alter chances of infection? Are there people infected with the COVID-19 virus who have no symptoms? How is spread of COVID-19 affected by vaccination rates? Is there any hesitancy to get the vaccine and what are the reasons? This information will be used to help keep the school open and the students and staff safe.
Eligible participants are those that work at the Mary Cariola Center (MCC) and interact with the students at MCC who have a high risk of infection from COVID-19.
The study lasts for up to 16 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 72 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IDD Student of the Mary Cariola Center
- •Age 3 - 18
- •Have a parent/guardian who can give informed consent
- •In the judgement of the Mary Cariola Medical Staff will be able to safely participate in the study procedures (nasal swab, phlebotomy)
- •Age 18 - 72
- •Able give informed consent
- •Anticipated duration of remaining employment less than 1 month (e.g. retiring)
- •Must be willing to participate in RT-PCR and antibody testing
排除标准
- •Contraindication to nasal swab
- •Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
- •Contraindication to nasal swab
- •Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
结局指标
主要结局
Number Infected With COVID-19
时间窗: 16 months
Number of students or staff who test positive for COVID-19 at least once using a nasal swab test.
Change in the Percentage of Participants Reporting Anxiety
时间窗: baseline to 16 months
Anxiety will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having anxiety if they were moderate or severe.
Change in the Percentage of Participants Classified as Depressed
时间窗: baseline to 16 months
Depression was measured using the PROMIS-29 assessment. Students or staff were classified within normal range, mild, moderate or severe. They were counted as having depression if they were moderate or severe.
Change in the Percentage of Participants Classified With Fatigue
时间窗: baseline to 16 months
Fatigue will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having fatigue if they were moderate or severe.
Change in Percentage of Participants With Deficits in Social Functioning
时间窗: baseline to 16 months
Social functioning will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having social functioning deficits if they were moderate or severe.
次要结局
未报告次要终点
研究者
John Foxe
Professor
University of Rochester