Back to resultsTesting for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD)
Primary Purpose
Covid19
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVID-19 RT-PCR test
COVID-19 Vaccine Education Campaign
Sponsored by
About this trial
This is an interventional health services research trial for Covid19
Eligibility Criteria
Inclusion Criteria:
Students:
- 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)
Staff
- 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:
Students
- Contraindication to nasal swab
- Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
Staff
- Contraindication to nasal swab
- Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
Sites / Locations
- Mary Cariola Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Students and staff at Mary Cariola Center
Arm Description
All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.
Outcomes
Primary Outcome Measures
Number of students infected with COVID-19
Number of students who test positive for COVID-19 at least once using a nasal swab test.
Number of staff infected with COVID-19
Number of staff who test positive for COVID-19 at least once using a nasal swab test.
Mean change in anxiety in students
Anxiety will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher anxiety.
Mean change in anxiety in staff
Anxiety will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher anxiety.
Mean change in depression in students
Depression will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher depression.
Mean change in depression in staff
Depression will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher depression.
Mean change in fatigue in students
Fatigue will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher fatigue.
Mean change in fatigue in staff
Fatigue will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher fatigue.
Mean change in social functioning in students
Social functioning will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher social disfunction.
Mean change in social functioning in staff
Social functioning will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher social disfunction.
Secondary Outcome Measures
Full Information
NCT ID
NCT04887129
First Posted
May 13, 2021
Last Updated
October 9, 2023
Sponsor
University of Rochester
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT04887129
Brief Title
Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD)
Official Title
COV-IDD: Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
950 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Students and staff at Mary Cariola Center
Arm Type
Experimental
Arm Description
All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.
Intervention Type
Diagnostic Test
Intervention Name(s)
COVID-19 RT-PCR test
Intervention Description
Participating individuals (students and employees) will be tested for COVID-19 (RT-PCR) using a specimen collected using a mid-turbinate swab.
This asymptomatic testing regime starts on or after (if scheduling testing requires this to begin on a different day) enrollment and is repeated every 5-14 days for up to 16 months . Anyone testing positive is followed up as described below for symptomatic individuals.
Those presenting with symptoms will be also tested for COVID-19 (RT-PCR). Those with negative test results will return to the asymptomatic testing protocol.
Students who test positive are retested then 3 days until two negative tests. Employees who test positive also be tested every 3 days until two negative tests.
Intervention Type
Other
Intervention Name(s)
COVID-19 Vaccine Education Campaign
Intervention Description
Utilizing information from focus groups, the investigators will develop and deploy an educational campaign aimed at improving vaccine hesitancy and student health
Primary Outcome Measure Information:
Title
Number of students infected with COVID-19
Description
Number of students who test positive for COVID-19 at least once using a nasal swab test.
Time Frame
16 months
Title
Number of staff infected with COVID-19
Description
Number of staff who test positive for COVID-19 at least once using a nasal swab test.
Time Frame
16 months
Title
Mean change in anxiety in students
Description
Anxiety will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher anxiety.
Time Frame
baseline to 16 months
Title
Mean change in anxiety in staff
Description
Anxiety will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher anxiety.
Time Frame
baseline to 16 months
Title
Mean change in depression in students
Description
Depression will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher depression.
Time Frame
baseline to 16 months
Title
Mean change in depression in staff
Description
Depression will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher depression.
Time Frame
baseline to 16 months
Title
Mean change in fatigue in students
Description
Fatigue will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher fatigue.
Time Frame
baseline to 16 months
Title
Mean change in fatigue in staff
Description
Fatigue will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher fatigue.
Time Frame
baseline to 16 months
Title
Mean change in social functioning in students
Description
Social functioning will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher social disfunction.
Time Frame
baseline to 16 months
Title
Mean change in social functioning in staff
Description
Social functioning will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher social disfunction.
Time Frame
baseline to 16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Students:
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)
Staff
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:
Students
Contraindication to nasal swab
Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
Staff
Contraindication to nasal swab
Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
Facility Information:
Facility Name
Mary Cariola Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD)
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