Clinical trial NCT05386355: Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool
Official title: Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Vaccines
Telemedicine
Vaccine Hesitancy
Pediatric ALL
Keywords: COVID-19
COVID-19 vaccination
Pediatric COVID-19 vaccination
mobile health
mHealth
Lead sponsor: IDeA States Pediatric Clinical Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institutes of Health (NIH)
name: University of Nebraska
name: University of Montana
First posted: 2022-05-23
Enrollment: 1934
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will use a 1:1 parallel design at the caregiver level to assign caregivers to the intervention (Vaccine Uptake app) or the control (General Health app) arm. The study team will stratify randomization by participating clinic and in varying block of participants using a permuted design. Randomization will occur after enrollment and before the baseline assessment.
Primary purpose: OTHER

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.

Eligibility criteria: Parent/Caregiver 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
* 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 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

Parent/Caregiver 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

Child Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of Children Who Complete COVID-19 Vaccination, as Verified in State, Clinic, or Participant-held Records
timeFrame: Week 24
Secondary outcomes:
measure: Proportion of Children Who Receive ≥1 Dose of the COVID-19 Vaccination Series, as Verified in State, Clinic, or Participant-held Records
timeFrame: Week 24
measure: Change in Enrolled Parent/Caregiver Domain Scores From Baseline to Immediately Post-intervention on the Modified WHO SAGE Vaccine Hesitancy Scale Adapted for the COVID-19 Vaccine
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Research Institute
state: Arkansas
city: Wilmington
country: United States
facility: Nemours Children's Health
state: Delaware
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Children's Research Institute
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Clinic
state: New Hampshire
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Nebraska
name: Russell J. McCulloh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nebraska
name: Ellen Kerns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Paul Darden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Songthip T Ounpraseuth, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.