COVID-19 Vaccines, Pediatric ALL, Telemedicine, Vaccine Hesitancy
Conditions
Keywords
COVID-19, COVID-19 vaccination, Pediatric COVID-19 vaccination, mobile health, mHealth
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.
Interventions
BEHAVIORALCOVID-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.
OTHERGeneral Health App
A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies.
Sponsors
National Institutes of Health (NIH)
University of Nebraska
University of Montana
IDeA States Pediatric Clinical Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Children Who Complete COVID-19 Vaccination, as Verified in State, Clinic, or Participant-held Records | Week 24 | Initiation and completion of the COVID-19 vaccine series during the 24-week intervention period. Vaccine series completion will be per ACIP guidance for the vaccine product. For children who receive a product that requires more than 2 doses for the primary series, receipt of up to 3 doses will be considered complete. Vaccine doses will be valid if given within 24-week study intervention. Additional doses for primary series completion will be valid if they are in accordance with ACIP-recommended interval minus a 4-day grace period. There will be no maximum interval between valid doses. An incorrect second vaccine product (i.e., mixed series) will be invalid. The statistical team will use a mixed model with the binomial distribution and the logit link to compare the two intervention groups and the proportions of children who complete COVID-19 vaccination, using a site random effect and controlling for clustering by caregiver. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Children Who Receive ≥1 Dose of the COVID-19 Vaccination Series, as Verified in State, Clinic, or Participant-held Records | Week 24 | For each vaccine-eligible child, this secondary endpoint will be defined as whether or not the child initiates the COVID-19 vaccine series during the 16 weeks of study participation. Vaccine series initiation will be receipt of at least 1 valid dose of any COVID-19 vaccine product. Vaccine doses for series initiation will only be valid for study purposes if given within the 16 weeks of study participation. The statistical team will use a mixed model with the binomial distribution and the logit link to compare the two intervention groups with respect to the proportions of children who initiate COVID-19 vaccination, using site as a random effect and controlling for clustering by caregiver. |
| 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 | 16 weeks | The Strategic Advisory Group of Experts on Immunization (SAGE) working group on vaccine hesitancy developed a vaccine hesitancy measure, the Vaccine Hesitancy Scale (VHS). The study team will evaluate parental attitude toward pediatric COVID-19 vaccination by using the vaccine hesitancy questionnaire that includes ten statements with ordinal responses using a 5-point Likert scale (1=strongly disagree,...,5=strongly agree). A composite vaccine hesitancy score was computed based on the sum of the 10 items after reverse coding items 1, 2, 3, 4, 6, 7, and 8 (range of 10 to 50). The reverse coding allowed for directionality uniformed across the 10 items; therefore, higher composite score indicated more hesitancy overall. We report summary statistics including means and standard deviation at baseline and week 16. A linear mixed mode was used to account for parent/caregivers nested within clinics and allow adjustment for baseline SAGE composite score. |
Countries
United States
Participant flow
Pre-assignment details
The protocol enrollment number of 727 represent the total number of parents/caregivers that were enrolled and randomized. For the study the unit of randomization is the parent/caregiver. The primary and secondary outcomes of interest, vaccine series completion and vaccine series initiation, were collected at the children level. Among these 727 parents/caregivers, there was a total of 1,207 children enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Vaccine Uptake App: Parents/Caregivers 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.
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. | 360 |
| General Health App: Parents/Caregivers 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.
General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies. | 365 |
| Vaccine Uptake App: Children 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.
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. | 611 |
| General Health App: Children 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.
General Health App: A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies. | 594 |
| Total | 1,930 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Each group had an ineligible child (i.e., one over 18 years old and one less than 6-months old). | 1 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Vaccine Uptake App: Children | General Health App: Children | Vaccine Uptake App: Parents/Caregivers | General Health App: Parents/Caregivers |
|---|---|---|---|---|---|
| Age, Customized Age, Customized 12 - 17 years | 194 Participants | 95 Participants | 99 Participants | — | — |
| Age, Customized Age, Customized 5 - 11 years | 467 Participants | 243 Participants | 224 Participants | — | — |
| Age, Customized Age, Customized 6 months - 5 years | 544 Participants | 273 Participants | 271 Participants | — | — |
| Caregiver Education Bachelor's degree | 90 Participants | 0 Participants | 0 Participants | 45 Participants | 45 Participants |
| Caregiver Education <= High school or GED completed | 154 Participants | 0 Participants | 0 Participants | 94 Participants | 60 Participants |
| Caregiver Education Master's/Doctoral | 46 Participants | 0 Participants | 0 Participants | 23 Participants | 23 Participants |
| Caregiver Education Missing | 9 Participants | 0 Participants | 0 Participants | 5 Participants | 4 Participants |
| Caregiver Education Some college/technical/vocational | 202 Participants | 0 Participants | 0 Participants | 85 Participants | 117 Participants |
| Caregiver Education Unknown/prefer not to answer | 11 Participants | 0 Participants | 0 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 335 Participants | 115 Participants | 95 Participants | 61 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1592 Participants | 495 Participants | 499 Participants | 298 Participants | 300 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
| Number of Children | 1 Number of Children | — | — | 1 Number of Children | 1 Number of Children |
| Race (NIH/OMB) American Indian or Alaska Native | 26 Participants | 5 Participants | 9 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 0 Participants | 6 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 706 Participants | 222 Participants | 222 Participants | 130 Participants | 132 Participants |
| Race (NIH/OMB) More than one race | 138 Participants | 52 Participants | 50 Participants | 17 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 158 Participants | 47 Participants | 48 Participants | 30 Participants | 33 Participants |
| Race (NIH/OMB) White | 886 Participants | 282 Participants | 258 Participants | 179 Participants | 167 Participants |
| Rurality (self-reported) No | 476 Participants | — | — | 245 Participants | 231 Participants |
| Rurality (self-reported) Yes | 249 Participants | — | — | 115 Participants | 134 Participants |
| Sex/Gender, Customized Female | 1260 Participants | 285 Participants | 294 Participants | 341 Participants | 340 Participants |
| Sex/Gender, Customized Male | 669 Participants | 326 Participants | 300 Participants | 18 Participants | 25 Participants |
| Sex/Gender, Customized Not listed/prefer not to answer | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 594 | 0 / 611 | 0 / 365 | 0 / 360 |
| other Total, other adverse events | 1 / 594 | 0 / 611 | 0 / 365 | 0 / 360 |
| serious Total, serious adverse events | 0 / 594 | 0 / 611 | 0 / 365 | 0 / 360 |
Outcome results
Primary
Proportion of Children Who Complete COVID-19 Vaccination, as Verified in State, Clinic, or Participant-held Records
Initiation and completion of the COVID-19 vaccine series during the 24-week intervention period. Vaccine series completion will be per ACIP guidance for the vaccine product. For children who receive a product that requires more than 2 doses for the primary series, receipt of up to 3 doses will be considered complete. Vaccine doses will be valid if given within 24-week study intervention. Additional doses for primary series completion will be valid if they are in accordance with ACIP-recommended interval minus a 4-day grace period. There will be no maximum interval between valid doses. An incorrect second vaccine product (i.e., mixed series) will be invalid. The statistical team will use a mixed model with the binomial distribution and the logit link to compare the two intervention groups and the proportions of children who complete COVID-19 vaccination, using a site random effect and controlling for clustering by caregiver.
Time frame: Week 24
Population: Randomization was at the parent/caregiver level; however, the unit of analysis for the primary (vaccine series completion) and secondary (vaccine series initiation) are at the children level. There were total of 1205 children (Vaccine Uptake N=611 and General Health N=595). Among the 1205, the vaccine completion outcome contained 11 missing observations (5 from Vaccine Uptake and 6 from General Health group).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaccine Uptake App: Children | Proportion of Children Who Complete COVID-19 Vaccination, as Verified in State, Clinic, or Participant-held Records | 13 Participants |
| General Health App: Children | Proportion of Children Who Complete COVID-19 Vaccination, as Verified in State, Clinic, or Participant-held Records | 7 Participants |
Comparison: A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.95% CI: [0.59, 5.35]
Secondary
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
The Strategic Advisory Group of Experts on Immunization (SAGE) working group on vaccine hesitancy developed a vaccine hesitancy measure, the Vaccine Hesitancy Scale (VHS). The study team will evaluate parental attitude toward pediatric COVID-19 vaccination by using the vaccine hesitancy questionnaire that includes ten statements with ordinal responses using a 5-point Likert scale (1=strongly disagree,...,5=strongly agree). A composite vaccine hesitancy score was computed based on the sum of the 10 items after reverse coding items 1, 2, 3, 4, 6, 7, and 8 (range of 10 to 50). The reverse coding allowed for directionality uniformed across the 10 items; therefore, higher composite score indicated more hesitancy overall. We report summary statistics including means and standard deviation at baseline and week 16. A linear mixed mode was used to account for parent/caregivers nested within clinics and allow adjustment for baseline SAGE composite score.
Time frame: 16 weeks
Population: The vaccine hesitancy secondary outcome is analyzed at the parent/caregiver level. Among the 725 parent/caregiver randomized, a total of 512 parent/caregiver completed the baseline survey.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Vaccine Uptake App: Children | 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 | 23.33 score on a scale |
| General Health App: Children | 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 | 23.10 score on a scale |
p-value: 0.63895% CI: [-1.19, 0.73]Mixed Models Analysis
Secondary
Proportion of Children Who Receive ≥1 Dose of the COVID-19 Vaccination Series, as Verified in State, Clinic, or Participant-held Records
For each vaccine-eligible child, this secondary endpoint will be defined as whether or not the child initiates the COVID-19 vaccine series during the 16 weeks of study participation. Vaccine series initiation will be receipt of at least 1 valid dose of any COVID-19 vaccine product. Vaccine doses for series initiation will only be valid for study purposes if given within the 16 weeks of study participation. The statistical team will use a mixed model with the binomial distribution and the logit link to compare the two intervention groups with respect to the proportions of children who initiate COVID-19 vaccination, using site as a random effect and controlling for clustering by caregiver.
Time frame: Week 24
Population: Randomization was at the parent/caregiver level; however, the unit of analysis for the primary (vaccine series completion) and secondary (vaccine series initiation) are at the children level. There were total of 1205 children (Vaccine Uptake N=611 and General Health N=595). Among the 1205, the vaccine completion outcome contained 11 missing observations (5 from Vaccine Uptake and 6 from General Health group).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaccine Uptake App: Children | Proportion of Children Who Receive ≥1 Dose of the COVID-19 Vaccination Series, as Verified in State, Clinic, or Participant-held Records | 22 Participants |
| General Health App: Children | Proportion of Children Who Receive ≥1 Dose of the COVID-19 Vaccination Series, as Verified in State, Clinic, or Participant-held Records | 25 Participants |
Comparison: A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.95% CI: [0.42, 1.65]