N/A N=51 Health Services Research

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

COVID-19 · Children With Medical Complexity (CMC)

Bottom Line

View on ClinicalTrials.gov: NCT04895085 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcome: Primary: Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants Approached — 51; 33 Caregiver/child dyads

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BinaxNOW Rapid Antigen System (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants Approached	51; 33	—
PRIMARY Change in Mean Number of Weekly in Home COVID-19 Tests	1.8	—
PRIMARY Change in COVID Test Rate at Home: Number of Total Tests Completed as Compared to Number of Tests Expected	3254; 2572	—
PRIMARY Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed	729	—
PRIMARY Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed	39; 3254	—
PRIMARY Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 Testing	1; 109	—
PRIMARY Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled Participants	32; 19	—
PRIMARY Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School	12; 39; 9; 39; 12; 34	—
PRIMARY Change in Susceptibility: School Takes Precautions	24; 27; 17; 31; 20; 26	—
PRIMARY Change in Susceptibility: Likely to Get COVID-19	22; 29; 18; 30; 21; 24	—
PRIMARY Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected	20; 18; 25; 14; 29; 14	—
PRIMARY Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced	17; 21; 20; 19; 18; 25	—
PRIMARY Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences	17; 21; 21; 18; 19; 24	—
PRIMARY Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)	33; 18; 29; 19; 29; 17	—
PRIMARY Change in Perceived Benefits to Attend School: Important to Health	37; 14; 29; 19; 31; 15	—
PRIMARY Change in Perceived Benefits to Attend School: In-person Schooling	35; 15; 33; 15; 32; 14	—
PRIMARY Change in Perceived Benefits to Attend School: Therapy Needs	38; 13; 32; 16; 33; 13	—
PRIMARY Change in Perceived Benefits to Attend School: Positive for Family	37; 13; 37; 11; 38; 8	—
PRIMARY Change in Perceived Benefits to Attend School: Positive for Staff	34; 16; 36; 11; 32; 14	—
PRIMARY Change in Perceived Benefits to Attend School: Keep Jobs	32; 19; 29; 19; 26; 20	—
PRIMARY Change in Barriers to School Attendance: Number of People	21; 30; 14; 34; 17; 29	—
PRIMARY Change in Barriers to School Attendance: Proximity	18; 32; 12; 36; 18; 28	—
PRIMARY Change in Barriers to School Attendance: PPE	24; 27; 20; 28; 25; 21	—
PRIMARY Change in Barriers to School Attendance: Testing	11; 40; 14; 34; 16; 29	—
PRIMARY Change in Barriers to School Attendance: Following Recommendations	13; 38; 15; 33; 14; 32	—
PRIMARY Change in Barriers to School Attendance: Transportation	5; 46; 1; 47; 3; 43	—
PRIMARY Change in Barriers to School Attendance: Wash	43; 8; 45; 3; 41; 5	—
PRIMARY Change in Barriers to School Attendance: Close Contact	47; 4; 42; 6; 41; 5	—
PRIMARY Change in Barriers to School Attendance: Masking	24; 27; 23; 25; 21; 25	—
PRIMARY Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)	29; 22; 31; 17; 34; 12	—
PRIMARY 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	29; 22; 35; 13; 35; 11	—
PRIMARY 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	14; 8; 9; 4; 8; 3	—

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.

Eligibility Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04895085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.