COVID-19NCT04895085
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
A study testing BinaxNOW Rapid Antigen System in people with COVID-19 and Children With Medical Complexity (CMC), run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Children With Medical Complexity (CMC)
- What is being tested?
- BinaxNOW Rapid Antigen System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- Failure to meet all inclusion criteria.
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792-4108
About this study
Official title: ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort SARS-CoV-2 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance
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.
Read the detailed description
During the first three months of the study, caregivers will be asked to perform the BinaxNOW Rapid Antigen test on their child twice-weekly. After the first three months of the study, the testing schedule will depend on the statewide (WI) community spread rate. If the rate of spread is above the threshold for higher risk of transmission in schools (defined by the CDC as ≥ 25 new cases per 100,000 population in past 7 days) caregivers will be asked to continue twice-weekly surveillance. If it is below the threshold, caregivers will be offered the option to continue twice-weekly testing or switch to symptomatic-only testing. The study staff will notify caregivers of changes in testing frequency during their weekly communication. Caregivers will be asked to document their testing activities, results, and any possible COVID-19 symptoms on a Parent Testing Log.
If testing produces a negative result, the caregiver will be instructed to document the test result on their testing log. While false negative tests are possible with asymptomatic individuals, there will be no change in standard mitigation measures based on the test results (mandatory masks in school, social distancing, hand hygiene, etc.).
If testing produces a positive result from an asymptomatic individual, the caregiver will be instructed to contact the study team immediately and then obtain a PCR (polymerase chain reaction) test within 48 hours. The study staff will assist the caregiver in making arrangements for this test. In the case of positive tests, children will be restricted from school activities per public health guidelines until the results of the PCR testing are known. If the PCR test returns as a negative result and the child is attending school in-person, they will be allowed to return to school the next day (or if symptomatic, once symptoms resolve). If the PCR returns as positive, the caregiver will be instructed to keep the child at home per public health guidelines. To support families and ensure these steps occur, the study staff will call families daily following positive tests.
- Conditions
- COVID-19, Children With Medical Complexity (CMC)
- Being tested
- BinaxNOW Rapid Antigen System
- Keywords
- Caregiver, in-person school attendance, In-home COVID testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BinaxNOW Rapid Antigen SystemDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver of Children with medical complexity (CMC) | Experimental | Not described Receives: Diagnostic Test: BinaxNOW Rapid Antigen System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Study duration (up to 21 months)
Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed
Data will be collected from parents via survey.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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?"
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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
Measured: 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
Measured: 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.
Measured: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start27 Apr 2021
- Primary completion15 Jun 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ryan Coller, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895085
- Sponsor's protocol ID
- 2021-0462
- Other IDs
- 1OT2HD107558-01, A536771, SMPH/PEDIATRICS, Protocol Version 04/12/21, 2022-0594
- Status last verified
- May 2024
- First submitted
- 14 May 2021
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort SARS-CoV-2 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance
- ClinicalTrials.gov ID
- NCT04895085
- Acronym / sponsor ID
- 2021-0462
- Conditions
- COVID-19, Children With Medical Complexity (CMC)
- Keywords
- Caregiver, in-person school attendance, In-home COVID testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During the first three months of the study, caregivers will be asked to perform the BinaxNOW Rapid Antigen test on their child twice-weekly. After the first three months of the study, the testing schedule will depend on the statewide (WI) community spread rate. If the rate of spread is above the threshold for higher risk of transmission in schools (defined by the CDC as ≥ 25 new cases per 100,000 population in past 7 days) caregivers will be asked to continue twice-weekly surveillance. If it is below the threshold, caregivers will be offered the option to continue twice-weekly testing or switch to symptomatic-only testing. The study staff will notify caregivers of changes in testing frequency during their weekly communication. Caregivers will be asked to document their testing activities, results, and any possible COVID-19 symptoms on a Parent Testing Log.
If testing produces a negative result, the caregiver will be instructed to document the test result on their testing log. While false negative tests are possible with asymptomatic individuals, there will be no change in standard mitigation measures based on the test results (mandatory masks in school, social distancing, hand hygiene, etc.).
If testing produces a positive result from an asymptomatic individual, the caregiver will be instructed to contact the study team immediately and then obtain a PCR (polymerase chain reaction) test within 48 hours. The study staff will assist the caregiver in making arrangements for this test. In the case of positive tests, children will be restricted from school activities per public health guidelines until the results of the PCR testing are known. If the PCR test returns as a negative result and the child is attending school in-person, they will be allowed to return to school the next day (or if symptomatic, once symptoms resolve). If the PCR returns as positive, the caregiver will be instructed to keep the child at home per public health guidelines. To support families and ensure these steps occur, the study staff will call families daily following positive tests.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Caregiver of Children with medical complexity (CMC) | Experimental | Diagnostic Test: BinaxNOW Rapid Antigen System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- Failure to meet all inclusion criteria.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BinaxNOW Rapid Antigen SystemBinaxNOW 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. | Diagnostic test | Caregiver of Children with medical complexity (CMC) |
Primary outcome
Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants Approached
Time frame: Study duration (up to 21 months)
Feasibility of home based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log.
Change in Mean Number of Weekly in Home COVID-19 Tests
Time frame: Every week up to 21 months
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.
Change in COVID Test Rate at Home: Number of Total Tests Completed as Compared to Number of Tests Expected
Time frame: Study duration (up to 21 months)
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.
Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed
Time frame: Study duration (up to 21 months)
Data will be collected from parents via survey.
Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed
Time frame: Study duration (up to 21 months)
Data will be collected from parents via survey.
Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 Testing
Time frame: Study duration (up to 21 months)
Data will be collected from parents via survey.
Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled Participants
Time frame: At month 3
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).
Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
"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)
Change in Susceptibility: School Takes Precautions
Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Susceptibility: Likely to Get COVID-19
Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected
Time frame: 15 month, 18 month, 21 month, 24 month
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")
Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced
Time frame: 15 month, 18 month, 21 month, 24 month
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")
Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences
Time frame: 15 month, 18 month, 21 month, 24 month
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")
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month
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?"
Change in Perceived Benefits to Attend School: Important to Health
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Perceived Benefits to Attend School: In-person Schooling
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Perceived Benefits to Attend School: Therapy Needs
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Perceived Benefits to Attend School: Positive for Family
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Perceived Benefits to Attend School: Positive for Staff
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Perceived Benefits to Attend School: Keep Jobs
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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
Change in Barriers to School Attendance: Number of People
Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Barriers to School Attendance: Proximity
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Barriers to School Attendance: PPE
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Barriers to School Attendance: Testing
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Barriers to School Attendance: Following Recommendations
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Barriers to School Attendance: Transportation
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Barriers to School Attendance: Wash
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Barriers to School Attendance: Close Contact
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Barriers to School Attendance: Masking
Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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")
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
Participants will answer the following survey question in Yes/No: * "Teachers/staff have asked for my child to attend school."- Y/N
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
Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
Participant will be asked the attendance question in survey. It will be answered in Yes/No
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
Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Coller, MD, MPH principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BinaxNOW Rapid Antigen System in people with COVID-19 and Children With Medical Complexity (CMC), run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants Approached (time frame: Study duration (up to 21 months)). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.