Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool

NCT ID: NCT05386355

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1934 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2023-09-25

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 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.

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 study enrollment.

The primary objective is to determine the effect of a parent-facing, vaccination decision-making mobile health (mHealth) tool on children's COVID-19 vaccine series completion. The endpoint of this objective is the proportion of children who complete COVID-19 vaccination, as verified in state, clinic, or participant-held records.

Secondary Objective 1 is to determine the effect of a parent-facing, vaccination decision-making mHealth tool on children's COVID-19 vaccine series initiation. The endpoint of this objective is the proportion of children who receive ≥1 dose of the COVID-19 vaccination series, as verified in state, clinic, or participant-held records

Secondary Objective 2 is to determine the effect of a parent-facing, vaccination decision-making mHealth tool on parental attitude toward pediatric COVID-19 vaccination. The endpoint of this objective is the change in enrolled parent/caregiver domain scores from baseline to week 16 on the modified World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) Vaccine Hesitancy Scale adapted for the COVID-19 Vaccine.

Enrolling sites will recruit participants. These sites will collaborate with outpatient practices within Environmental influences on Child Health Outcomes (ECHO) Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) states that provide primary care services to children (<18 years old). Sites will serve a population base of at least 40% Medicaid/uninsured children, <60% non-Hispanic White children, or >40% of families residing in rural communities. Sites are encouraged, but not required, to have a high Spanish-speaking population.

Study interventions are a Vaccine Uptake App and General Health App. The Vaccine Uptake App will include 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.

The General Health App will include 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 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). Nudges regarding these topics will be sent to participants via push notifications to their mobile devices.

The study duration is 24 months (6 months study start-up; up to 8 months rolling enrollment; 7 months final participants' completion; 3 months analysis). Participant duration is 27 weeks.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

COVID-19 Vaccine Uptake App

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

General Health App

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

General Health App

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

• 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

• Not a patient of a participating clinic
• Prior receipt of least one dose of COVID-19 vaccine
• Receiving or scheduled to receive COVID-19 vaccination at the time of parental consent
• Known medical contraindication to all COVID-19 vaccines
• Ineligible to receive COVID-19 vaccine
• Prior or current participation in a COVID-19 vaccine study of any kind

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: collaborator

University of Montana

OTHER

Sponsor Role: collaborator

IDeA States Pediatric Clinical Trials Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell J. McCulloh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Ellen Kerns, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Paul Darden, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Songthip T Ounpraseuth, PhD

Role: STUDY_DIRECTOR

University of Arkansas

Locations

Arkansas Children's Research Institute

Little Rock, Arkansas, United States

Nemours Children's Health

Wilmington, Delaware, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Norton Children's Research Institute

Louisville, Kentucky, United States

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Dartmouth Hitchcock Clinic

Lebanon, New Hampshire, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Avera Research Institute

Sioux Falls, South Dakota, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

References

McCulloh RJ, Darden PM, Snowden J, Ounpraseuth S, Lee J, Clarke M, Newcomer SR, Fu L, Hubberd D, Baldner J, Garza M, Kerns E. Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial. Trials. 2022 Oct 28;23(1):911. doi: 10.1186/s13063-022-06819-3.

Reference Type: DERIVED

PMID: 36307830 (View on PubMed)

McCulloh RJ, Darden P, Snowden J, Ounpraseuth S, Lee J, Clarke M, Newcomer SR, Fu L, Hubberd D, Baldner J, Garza M, Kerns E. Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUP): a randomized, controlled trial. Res Sq [Preprint]. 2022 Oct 10:rs.3.rs-2070396. doi: 10.21203/rs.3.rs-2070396/v1.

Reference Type: DERIVED

PMID: 36238712 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U24OD024957

Identifier Type: NIH

Identifier Source: secondary_id

View Link

273761

Identifier Type: -

Identifier Source: org_study_id