Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool: a Randomized, Controlled Trial

Status: Completed
Location: See all (15) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

• 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

Locations
United States
Arkansas
Arkansas Children's Research Institute
Little Rock
Delaware
Nemours Children's Health
Wilmington
Hawaii
Kapiolani Medical Center for Women and Children
Honolulu
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
Norton Children's Research Institute
Louisville
Louisiana
Our Lady of the Lake Regional Medical Center
Baton Rouge
Mississippi
University of Mississippi Medical Center
Jackson
Nebraska
University of Nebraska Medical Center
Omaha
New Hampshire
Dartmouth Hitchcock Clinic
Lebanon
New Mexico
University of New Mexico Health Sciences Center
Albuquerque
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Medical University of South Carolina
Charleston
South Dakota
Avera Research Institute
Sioux Falls
West Virginia
West Virginia University
Morgantown
Time Frame
Start Date: 2022-07-18
Completion Date: 2023-09-25
Participants
Target number of participants: 727
Treatments
Experimental: Vaccine Uptake App
24-week (8 weeks with weekly push notifications; 2 monthly push notifications for 2 months \[1 notification per month\]; 8 weeks without) exposure to a mobile phone application (app) designed to improve parental knowledge, attitudes, and self-efficacy regarding pediatric COVID-19 vaccination. The app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will also receive eight weekly nudges and 1 monthly nudge for 2 months (cues to action) regarding vaccinating their child that will be sent to participants via push notifications to their mobile devices. Through branching logic, users will access content tailored to their COVID-19 vaccine knowledge and confidence gaps, locality, degree of rural-urban primary residence, primary language (English/Spanish), race/ethnicity, and child's age.
Active_comparator: General Health App
24-week (8 with weekly push notifications; 2 monthly push notifications for 2 months \[1 notification per month\]; 8 weeks without) exposure to a mobile phone app designed to provide information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). Eight weekly nudges and 1 monthly nudge for 2 months regarding these topics will be sent to participants via push notifications to their mobile devices.
Sponsors
Collaborators: University of Nebraska, University of Montana, National Institutes of Health (NIH)
Leads: IDeA States Pediatric Clinical Trials Network

This content was sourced from clinicaltrials.gov