Status:

COMPLETED

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

Lead Sponsor:

University of Wisconsin, Madison

Collaborating Sponsors:

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

Conditions:

COVID-19

Children With Medical Complexity (CMC)

Eligibility:

All Genders

18+ years

Phase:

NA

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 i...

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 sche...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

April 27 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 15 2023

Estimated Enrollment :

51 Patients enrolled

Trial Details

Trial ID

NCT04895085

Start Date

April 27 2021

End Date

September 15 2023

Last Update

June 7 2024

Active Locations (1)

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1

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States, 53792-4108