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| ID | Type | Description | Link |
|---|---|---|---|
| U24OD024957 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of Nebraska | OTHER |
| University of Montana | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Uptake App | Experimental | 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. |
|
| General Health App | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccine Uptake App | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Parent/Caregiver Inclusion Criteria:
Child Inclusion Criteria:
Parent/Caregiver Exclusion Criteria:
Child Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russell J. McCulloh, MD | University of Nebraska | Principal Investigator |
| Ellen Kerns, PhD | University of Nebraska | Principal Investigator |
| Paul Darden, MD | University of Arkansas | Principal Investigator |
| Songthip T Ounpraseuth, PhD | University of Arkansas | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Research Institute | Little Rock | Arkansas | 72202 | United States | ||
| Nemours Children's Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36307830 | Derived | 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. | |
| 36238712 | Derived | 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. |
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We will conduct this trial in accordance with the following publication and data sharing policies and regulations:
Per data sharing polices of NIH and the ISPCTN
to be announced
Not provided
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2023 | Sep 25, 2024 |
Not provided
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.
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| General Health App | Other | A mobile application (app) that will provide general pediatric health and infection prevention and mitigation strategies. |
|
| Week 24 |
| 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. | 16 weeks |
| Wilmington |
| Delaware |
| 19803 |
| United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96813 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Norton Children's Research Institute | Louisville | Kentucky | 40202 | United States |
| Our Lady of the Lake Regional Medical Center | Baton Rouge | Louisiana | 70808 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Dartmouth Hitchcock Clinic | Lebanon | New Hampshire | 03756 | United States |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87102 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Avera Research Institute | Sioux Falls | South Dakota | 57108 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
A total of 727 parent/caregiver were enrolled and randomized. Two participants were ineligible (1 from Vaccine Uptake App and 1 from General Health App) since one had a child over 18 years old and the other had a child < 6 months old. Therefore, the final analytical sample size was 725 parent/caregiver (Vaccine Uptake App N = 360 and General Health App N = 365) and 1205 children (Vaccine Uptake App N = 611 and General Health App N = 594).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Measure Description: Age was not collected for parent/caregiver. | Measure Description: Age was not collected for parent/caregiver. | Count of Participants | Participants |
| |||||||||
| Sex/Gender, Customized | The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row. | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | The number analyzed in the row represents the number of parent/caregiver and children in each of the four defined groups (Vaccine Uptake App Parents/Caregivers; General Health Parent/Caregivers; Vaccine Uptake Children; General Health Children). However, the total overall number represents the sum of parent/caregiver plus children for each row. | Count of Participants | Participants |
| ||||||||||
| Caregiver Education | For the education measure, only 512 parent/caregivers completed the baseline survey (General Health App N = 255 and Vaccine Uptake App N = 257). | Count of Participants | Participants |
| ||||||||||
| Number of Children | The number analyzed in the row represents the number of parent/caregiver since this measure is only relevant at the parent/caregiver level. | Median | Inter-Quartile Range | Number of Children |
| |||||||||
| Rurality (self-reported) | The number analyzed in the row represents the number of parent/caregiver since rurality is only reported at the parent/caregiver level. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 16 weeks |
|
32 weeks
The unit of randomization was at the parent/caregiver level. We randomized 727 parent/caregiver (2 participants were ineligible with one participant having an only child over 18 years old while another participant had an only child under 6 months old). The unit of analysis is at the children level. There were a total of 1205 children (General Health App N=594 and Vaccine Uptake N=611). There were no adverse events reported at the parent/caregiver level.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 594 | 0 | 594 | 1 | 594 |
| EG001 | 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. | 0 | 611 | 0 | 611 | 0 | 611 |
| EG002 | 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. | 0 | 365 | 0 | 365 | 0 | 365 |
| EG003 | 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. | 0 | 360 | 0 | 360 | 0 | 360 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Metabolism and nutrition disorders | Non-systematic Assessment | New onset diabetes |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Songthip Ounpraseuth | University of Arkansas for Medical Sciences | 501-686-7233 | stounpraseuth@uams.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2023 | Sep 26, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2022 | Mar 20, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000088823 | Vaccination Hesitancy |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
|
|
| Female |
|
|
| Not listed/prefer not to answer |
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| Some college/technical/vocational |
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| Bachelor's degree |
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| Master's/Doctoral |
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| Unknown/prefer not to answer |
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| Missing |
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| No |
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| OG001 | 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. |
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| OG001 | 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. |
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