ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort COVID-19 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance

NCT04895085 | Completed Results FDA Device

• 6 other identifiers: 2021-04621OT2HD107558-01A536771SMPH/PEDIATRICSProtocol Version 04/12/212022-0594
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to learn about the factors parents consider when deciding whether their child will go to school in-person or attend from home. Investigators are also interested in learning whether access to in-home COVID testing is of value to parents and also whether it affects decision-making about returning to school. This study is being done at UW-Madison in partnership between the Department of Pediatrics and the Department of Industrial and Systems Engineering. A total of 50 caregivers (plus their children with medical complexity) will participate in this study. Additionally, 20 caregivers involved in the study may also be invited to participate in a one-hour, virtual visit in which the caregiver demonstrates and discusses how they perform in-home COVID testing with their child. The results of the study may help researchers advance their understanding of in-home testing strategies for children with medical complexity.

Conditions

COVID-19; Children With Medical Complexity (CMC)

Keywords

Caregiver; in-person school attendance; In-home COVID testing

Outcome Measures

Primary Outcomes (32)

• Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants Approached

  Feasibility of home based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log.

  Study duration (up to 21 months)

• Change in Mean Number of Weekly in Home COVID-19 Tests

  Feasibility of home based COVID-19 testing will be evaluated by the mean number of weekly in home COVID-19 tests run by parents/caregivers. Data will be collected by survey.

  Every week up to 21 months

• Change in COVID Test Rate at Home: Number of Total Tests Completed as Compared to Number of Tests Expected

  Data will be collected by survey. * Tests expected: Various scenarios factor into the tests expected value. Caregivers were expected to test their child twice a week every week for the first three months. After that time, caregivers could opt-in to surveillance testing (expected testing twice a week every week) or proceed with symptomatic-only testing (no "expected" tests for caregivers). Additionally, caregivers were not expected to test for 90 days after their child tested positive. * Tests completed: Caregivers were allowed to test more often than twice a week if appropriate (e.g., exposure to COVID-19). All symptomatic-only tests were not considered expected tests. These factors allowed the number of tests completed to exceed the number of tests expected.

  Study duration (up to 21 months)

• Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed

  Data will be collected from parents via survey.

  Study duration (up to 21 months)

• Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed

  Data will be collected from parents via survey.

  Study duration (up to 21 months)

• Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 Testing

  Data will be collected from parents via survey.

  Study duration (up to 21 months)

• Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled Participants

  Data will be collected from parents via survey. \- Caregivers were expected to test their child twice a week every week for the first three months. After that time, caregivers could opt-in to surveillance testing (expected testing twice a week every week) or proceed with symptomatic-only testing (no "expected" tests for caregivers).

  At month 3

• Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School

  "How many of the people who interact with your child at school have been fully vaccinated?" Response options: "None", "A few", "Some" "Most", "All", "Don't Know" Dichotomized into: ("Most" or "All") vs. ("None", "A few", "Some", "Don't Know)

  baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Susceptibility: School Takes Precautions

  The following question from the Participant's perceived susceptibility survey will be answered dichotomously and presented qualitatively: * How comfortable are you with...the ability of your child's school to take all precautions to stop the spread of COVID-19? * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Susceptibility: Likely to Get COVID-19

  Following questions from the Participant's perceived susceptibility survey will be answered dichotomously (agree or disagree) and presented qualitatively. * In your opinion, how likely is your child to get sick with COVID-19 by attending school in-person? * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected

  Parent survey perceived severity construct variables will include: * If your child was sick with COVID-19, how likely would...their health be severely affected * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  15 month, 18 month, 21 month, 24 month

• Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced

  Parent survey perceived severity construct variables will be: * "If your child was sick with COVID-19, how likely would...their health be permanently reduced" * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  15 month, 18 month, 21 month, 24 month

• Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences

  Parent survey perceived severity construct variables will be: * "If my child was sick with COVID-19, they would have grave health consequences." * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  15 month, 18 month, 21 month, 24 month

• Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)

  Participants will answer the following survey question in quite a bit / a great deal vs not: * "Based on the situation right now, how much do you want your child to attend school in-person at least some of the time?"

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month

• Change in Perceived Benefits to Attend School: Important to Health

  Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. * How important is attending school in-person to your child's overall health? * Dichotomized into: ("Not at all important", "A little important", "Somewhat important") vs. ("Very important", "Extremely important")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Perceived Benefits to Attend School: In-person Schooling

  Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, and impact on family. Survey will be analyzed qualitatively. * Compared to fully virtual school, how much better or worse is attending any school in-person for your child? * Dichotomized into: ("Quite a bit worse", "Somewhat worse", "A little bit worse", "Neither better nor worse") vs. ("A little bit better", "Somewhat better", "Quite a bit better")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Perceived Benefits to Attend School: Therapy Needs

  Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. * How much of your child's therapy needs are only met by attending school in-person? * Dichotomized into: ("None", "A few", "Some" vs. "Most", "All")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Perceived Benefits to Attend School: Positive for Family

  Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. * How positive or negative is your child attending school in-person for...your family * Dichotomized into: ("Very negative", "Somewhat negative", "A little negative", "Neutral") vs. ("A little positive", "Somewhat positive", "Very positive")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Perceived Benefits to Attend School: Positive for Staff

  Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. * How positive or negative is your child attending school in-person for...the staff and teachers * Dichotomized into: ("Very negative", "Somewhat negative", "A little negative", "Neutral") vs. ("A little positive", "Somewhat positive", "Very positive")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Perceived Benefits to Attend School: Keep Jobs

  Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. * Does your child attending school in-person help the adults in your family to keep their jobs? * Response options: Yes / No

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Barriers to School Attendance: Number of People

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with the number of people around your child at school? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Barriers to School Attendance: Proximity

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with how close people have to be to your child at school? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Barriers to School Attendance: PPE

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with the amount personal protective equipment (PPE), such as masks and gloves, available at school? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Barriers to School Attendance: Testing

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with the amount of COVID-19 testing among school staff and classmates? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Barriers to School Attendance: Following Recommendations

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with how closely parents of classmates follow recommendations to keep your child safe? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Barriers to School Attendance: Transportation

  Survey will have following questions which will be answered dichotomously very/extremely vs not. * How difficult is it to transport your child to or from school as a result of COVID-19? * Dichotomized as: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Barriers to School Attendance: Wash

  Survey will have following questions which will be answered dichotomously very/extremely vs not. * In your child's school, do they have access to necessary facilities to wash? * Dichotomized as: ("Yes, all of the time", "Yes, most of the time") vs. ("Some of the time", "Rarely", "Not at all")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Barriers to School Attendance: Close Contact

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * While in school, is your child required to be in close contact (i.e., within 6 ft) with others? 'Others' includes teachers, aides, nurses, and classmates. * Dichotomized as: ("Yes, all of the time", "Yes, most of the time") vs. ("Some of the time", "Rarely", "Not at all")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Barriers to School Attendance: Masking

  Survey will have following questions which will be answered dichotomously very/extremely vs not. * While in school, is your child able to wear a mask? * Dichotomized as: ("Yes, all of the time", "Yes, most of the time") vs. ("Some of the time", "Rarely", "Not at all")

  Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)

  Participants will answer the following survey question in Yes/No: * "Teachers/staff have asked for my child to attend school."- Y/N

  baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N

  Participant will be asked the attendance question in survey. It will be answered in Yes/No

  baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

• Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N

  Participant will be asked the attendance question in survey. It will be answered in Yes/No. Survey branching logic asked this question only to participants whose child was not currently attending school in person, either full-time or as part of a hybrid or part-time schedule. The number analyzed represents the number of participants that answered this question.

  baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Study Arms (1)

Caregiver of Children with medical complexity (CMC)

EXPERIMENTAL

Diagnostic Test: BinaxNOW Rapid Antigen System

Interventions

BinaxNOW Rapid Antigen System DIAGNOSTIC_TEST

BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.

Caregiver of Children with medical complexity (CMC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, the caregiver/child must meet the following criteria:
• The caregiver is willing to comply with all study procedures and expects to be available for the duration of the study.
• The caregiver is at least 18 years of age.
• The caregiver is proficient in English.
• The caregiver is self-identified as the primary caregiver (parent, foster parent, legal guardian) of a CMC who is aged 5-16 years at the start of the study and who is enrolled in the Pediatric Complex Care Program (PCCP) at the University of WI-Madison.
• The caregiver is currently providing care on an ongoing basis to their CMC. The child may not be housed in a skilled nursing facility, an acute care or transitional facility, a rehabilitative hospital, a medical group home or in a foster home (unless the primary caregiver for the study is the foster parent).
• The caregiver has access to a web-enabled device (phone, tablet, or computer).
• Caregiver and child are residents of Wisconsin.
• The child attended in-person school pre-pandemic. (Child can currently be attending school in-person, remotely or a hybrid combination).
• The caregiver provides a written informed consent form.

You may not qualify if:

• The child is hospitalized at the time of enrollment (visit may be rescheduled)
• Children not currently enrolled in public or private school and whose caregiver has no plan to enroll them in the Fall of 2021 (e.g., children currently homeschooling with plans to homeschool in the Fall of 2021 are ineligible).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792-4108, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Ryan Coller
• Organization: University of Wisconsin School of Medicine and Public Health

rcoller@pediatrics.wisc.edu

608-263-9408

Study Officials

• Ryan Coller, MD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single site study taking place over 24 months and involving (50) caregivers and their children with medical complexity. Additionally, (20) of these caregivers will be invited to participate in an hour-long, virtual contextual inquiry session.

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 20, 2021
• Study Start: April 27, 2021
• Primary Completion: June 15, 2023
• Study Completion: September 15, 2023
• Last Updated: June 7, 2024
• Results First Posted: June 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)