Back to results

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

Primary Purpose

COVID-19, Children With Medical Complexity (CMC)

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BinaxNOW Rapid Antigen System

About this trial

This is an interventional health services research trial for COVID-19 focused on measuring Caregiver, in-person school attendance, In-home COVID testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Sites / Locations

University of Wisconsin School of Medicine and Public Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Caregiver of Children with medical complexity (CMC)

Arm Description

Outcomes

Primary Outcome Measures

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.

Change in Mean number of weekly in home COVID-19 tests

Feasibility of home based COVID-19 testing will be evaluated by 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

Data will be collected by survey.

Change in Symptomatic test rate: number of symptomatic tests completed compared to total number of participants enrolled

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

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

Data will be collected from parents via survey.

Surveillance opt in: number of participants opting into surveillance compared to total number of enrolled participants

Data will be collected from parents via survey.

Change in susceptibility: Number of fully vaccinated people who interact with participant's child at school

Change in susceptibility: Survey items answered dichotomously (agree or disagree)

Following questions from the Participant's perceived susceptibility survey will be answered dichotomously (agree or disagree) 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? In your opinion, how likely is your child to get sick with COVID-19 by attending school in-person?

Change in percentage of participants who chose each option in response to the perceived severity survey question

Parent survey perceived severity construct variables will be: "If my child was sick with COVID-19, their health would be severely affected." "If my child was sick with COVID-19, they would have grave health consequences." "If my child was sick with COVID-19, their health would be permanently reduced."

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?"

Change in perceived benefits to attend school

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.

Change in barriers to school attendance: Survey answered dichotomously very/extremely [comfortable] vs not.

Survey will have following questions which will be answered dichotomously very/extremely [comfortable] vs not. It How comfortable are you with... the number of people around your child at school? how close people have to be to your child at school? the amount personal protective equipment (PPE), such as masks and gloves, available at school? the amount of COVID-19 testing among school staff and classmates? how closely parents of classmates follow recommendations to keep your child safe? How difficult is it to transport your child to or from school as a result of COVID-19? In your child's school, do they have access to necessary facilities to wash? 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. While in school, is your child able to wear a mask?

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04895085

First Posted

May 14, 2021

Last Updated

July 31, 2023

Sponsor

University of Wisconsin, Madison

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT04895085

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 27, 2021 (Actual)

Primary Completion Date

June 15, 2023 (Actual)

Study Completion Date

September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Children With Medical Complexity (CMC)

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Caregiver of Children with medical complexity (CMC)

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

BinaxNOW Rapid Antigen System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Protocol uptake: Number of Participants Consented Compared to Number of participants approached

Description

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

Time Frame

Study duration (up to 21 months)

Title

Change in Mean number of weekly in home COVID-19 tests

Description

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

Time Frame

Every week up to 21 months

Title

Change in COVID test rate at home: Number of total tests completed as compared to number of tests expected

Description

Data will be collected by survey.

Time Frame

Study duration (up to 21 months)

Title

Change in Symptomatic test rate: number of symptomatic tests completed compared to total number of participants enrolled

Description

Data will be collected from parents via survey.

Time Frame

Study duration (up to 21 months)

Title

Change in Positive rate: Number of positive COVID-19 tests compared to total number of tests performed

Description

Data will be collected from parents via survey.

Time Frame

Study duration (up to 21 months)

Title

Change in False-positive rate: number of negative confirmatory Polymerase chain reaction (PCR) as compared to total PCR run for COVID-19 testing

Description

Data will be collected from parents via survey.

Time Frame

Study duration (up to 21 months)

Title

Surveillance opt in: number of participants opting into surveillance compared to total number of enrolled participants

Description

Data will be collected from parents via survey.

Time Frame

At month 3

Title

Change in susceptibility: Number of fully vaccinated people who interact with participant's child at school

Time Frame