Status:
COMPLETED
Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool
Lead Sponsor:
IDeA States Pediatric Clinical Trials Network
Collaborating Sponsors:
National Institutes of Health (NIH)
University of Nebraska
Conditions:
COVID-19 Vaccines
Telemedicine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will determine the effectiveness of a vaccine communication mobile health app on parental decisions to vaccinate their children against coronavirus disease 2019 (COVID-19). The hypothesis ...
Detailed Description
This is a site-level block-randomized trial. The study population is Custodial parents/caregivers with ≥1 child eligible for COVID-19 vaccination who has not yet received the vaccine at the time of st...
Eligibility Criteria
Inclusion
- Parent/Caregiver
- Age of majority, as defined by the state of residency
- Access to a mobile device that can store and run the study app for 24 weeks. Devices that can run the app include mobile phones and tablets running Android or iOS operating systems
- Able to speak and read in English or Spanish
- Be a parent/caregiver with primary medical decision-making and legal authority to consent to vaccination decisions for at least one child who meets the child inclusion criteria
- Child
- Age 6 months to less than age of majority, as defined by the child's state of residence
- Has not received any doses of COVID-19 vaccine based on parent/caregiver report
- Eligible to receive COVID-19 vaccine
- Patient at a participating clinic
- Parent/Caregiver
Exclusion
- Has only a child or children with known contraindication to all COVID-19 vaccines
- Has only a child or children whose other parent/caregiver is already a current or past participant in the study
- Has a child or children enrolled in any other COVID-19 vaccine study of any kind
- Past or present participation in a COVID-19 vaccine or behavioral trial
- Has a cognitive impairment that limits their ability to engage with the app content and/or make medical decisions regarding vaccination, based on the site investigator's assessment and local human subjects research policies
- Child
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2023
Estimated Enrollment :
1934 Patients enrolled
Trial Details
Trial ID
NCT05386355
Start Date
July 18 2022
End Date
September 25 2023
Last Update
March 11 2025
Active Locations (15)
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1
Arkansas Children's Research Institute
Little Rock, Arkansas, United States, 72202
2
Nemours Children's Health
Wilmington, Delaware, United States, 19803
3
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96813
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160