COV-IDD: Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 392
- Locations
- 2
- Primary Endpoint
- Number Infected With COVID-19
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 72 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Contraindication to nasal swab
- •Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
- •Contraindication to nasal swab
- •Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
Outcomes
Primary Outcomes
Number Infected With COVID-19
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
John Foxe
Professor
University of Rochester