Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool

NCT05386355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1934

Last updated 2025-03-11

Study results available
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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 is that unvaccinated children of caregivers assigned to the Vaccine Uptake app will be more likely to achieve COVID-19 vaccine series completion than those children whose caregivers are assigned to the General Health app.

Conditions

  • COVID-19 Vaccines
  • Telemedicine
  • Vaccine Hesitancy
  • Pediatric ALL

Interventions

BEHAVIORAL

COVID-19 Vaccine Uptake App

A mHealth mobile application (app) that will provide educational and logistical information about the COVID-19 vaccination for children. The target audience will be parents of unvaccinated children.

OTHER

General Health App

A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • University of Nebraska

    collaborator OTHER
  • University of Montana

    collaborator OTHER
  • IDeA States Pediatric Clinical Trials Network

    lead NETWORK

Principal Investigators

  • Russell J. McCulloh, MD · University of Nebraska

  • Ellen Kerns, PhD · University of Nebraska

  • Paul Darden, MD · University of Arkansas

  • Songthip T Ounpraseuth, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2023-09-25
Completion
2023-09-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386355 on ClinicalTrials.gov