Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | COVID-19 Vaccination | Study protocol

Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial

Authors: Russell J. McCulloh, Paul M. Darden, Jessica Snowden, Songthip Ounpraseuth, Jeannette Lee, Martina Clarke, Sophia R. Newcomer, Linda Fu, DeAnn Hubberd, Jaime Baldner, Maryam Garza, Ellen Kerns

Published in: Trials | Issue 1/2022

Login to get access

Abstract

Background

Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and other medically underserved communities. The research objective of the current protocol is to determine the effectiveness of a vaccine communication mobile health (mHealth) application (app) on parental decisions to vaccinate their children against COVID-19.

Methods

Custodial parents/caregivers with ≥ 1 child eligible for COVID-19 vaccination who have not yet received the vaccine will be randomized to download one of two mHealth apps. The intervention app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will receive eight weekly push notifications followed by two monthly push notifications (cues to action) regarding vaccinating their child. Through branching logic, users will access customized content based on their locality, degree of rurality-urbanicity, primary language (English/Spanish), race/ethnicity, and child’s age to address COVID-19 vaccine knowledge and confidence gaps. The control app will provide push notifications and 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). The primary outcome is the proportion of children who complete COVID-19 vaccination series. Secondary outcomes include the proportion of children who receive ≥ 1 dose of COVID-19 vaccine and changes in parent/caregiver scores from baseline to immediately post-intervention on the modified WHO SAGE Vaccine Hesitancy Scale adapted for the COVID-19 vaccine.

Discussion

The COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-19 vaccination rates across diverse settings and provide an evidentiary base for app-based vaccine communication tools that can be adapted to future vaccine-deployment efforts.

Clinical trials registration

ClinicalTrials.gov NCT05386355. Registered on May 23, 2022.
Literature
1.
Mahase E. Covid-19: Moderna applies for US and EU approval as vaccine trial reports 94.1% efficacy. BMJ. 2020;371:m4709.CrossRefPubMed
2.
Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69(50):1922–4.CrossRefPubMedPubMedCentral
3.
4.
COVID Collaborative LR, UnidosUS, NAACP. COVID Collaborative Survey: Coronavirus Vaccination Hesitancy in the Black and Latinx Communities November 23, 2020 2020.
5.
6.
7.
8.
Chou WS, Burgdorf CE, Gaysynsky A, Hunter CM. COVID-19 Vaccination Communication: Applying Behavioral and Social Science to Address Vaccine Hesitancy and Foster Vaccine Confidence. 2020.
9.
National Institutes of Health Community Engagement Alliance (CEAL), Communication Work Group. Addressing COVID-19 Misinformation: A Tip Sheet for Health Professionals Working with Community Members. Toolkit: Adapting Fact-Based Information to the Needs of Communities: A Guide Web site. https://​covid19community​.​nih.​gov/​communication-resources. Published 2021. Updated April 19, 2021. Accessed 14 Sept 2021.
10.
11.
12.
13.
Szilagyi PG, Shah MD, Delgado JR, Thomas K, Vizueta N, Cui Y, Vangala S, Shetgiri R, Kapteyn A. Parents’ Intentions and Perceptions About COVID-19 Vaccination for Their Children: Results From a National Survey. Pediatrics. 2021;3:e2021052335.
14.
Nguyen KH, Srivastav A, Razzaghi H, et al. COVID-19 Vaccination Intent, Perceptions, and Reasons for Not Vaccinating Among Groups Prioritized for Early Vaccination - United States, September and December 2020. MMWR Morb Mortal Wkly Rep. 2021;70:217–22.CrossRefPubMedPubMedCentral
15.
Snowden J, Darden P, Palumbo P, Saul P, Lee J. The institutional development award states pediatric clinical trials network: building research capacity among the rural and medically underserved. Curr Opin Pediatr. 2018;30(2):297–302.CrossRefPubMedPubMedCentral
16.
Saelee R, Zell E, Murthy BP, Castro-Roman P, Fast H, Meng L, Shaw L, Gibbs-Scharf L, Chorba T, Harris LQ, Murthy N. Disparities in COVID-19 Vaccination Coverage Between Urban and Rural Counties - United States, December 14, 2020-January 31, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(9):335–40.CrossRefPubMedPubMedCentral
17.
Ndugga N, Pham O, Hill L, Artiga S, Parker N. Latest Data on COVID-19 Vaccinations by Race/Ethnicity. 2022.
18.
Champion VSC. The Health Belief Model. In: Glanz KRB, Viswanath K, editors. Health Behavior and Health Education. 4th ed. San Francisco: Jossey-Bass; 2008. p. 45–65.
19.
Mercadante AR, Law AV. Will they, or Won’t they? Examining patients’ vaccine intention for flu and COVID-19 using the Health Belief Model. Res Social Adm Pharm. 2020.
20.
Gilkey MB, Magnus BE, Reiter PL, McRee AL, Dempsey AF, Brewer NT. The Vaccination Confidence Scale: a brief measure of parents’ vaccination beliefs. Vaccine. 2014;32(47):6259–65.
21.
The Security Rule. Health Information Privacy Web site. Published 2017. Accessed 12 June 2017.
22.
Keelan KWKAJ. Using Mobile Technology To Overcome Jurisdictional Challenges To A Coordinated Immunization Policy. In: Health Affairs Blog, vol. 2. USA: SAS; 2014.
23.
Fadda M, Galimberti E, Fiordelli M, Romanò L, Zanetti A, Schulz PJ. Effectiveness of a smartphone app to increase parents’ knowledge and empowerment in the MMR vaccination decision: A randomized controlled trial. Hum Vaccin Immunother. 2017;13(11):2512–21.CrossRefPubMedPubMedCentral
24.
Wilson K, Atkinson KM, Westeinde J. Apps for immunization: Leveraging mobile devices to place the individual at the center of care. Hum Vaccin Immunother. 2015;11(10):2395–9.CrossRefPubMedPubMedCentral
25.
Shourie S, Jackson C, Cheater FM, et al. A cluster randomised controlled trial of a web based decision aid to support parents’ decisions about their child’s Measles Mumps and Rubella (MMR) vaccination. Vaccine. 2013;31(50):6003–10.CrossRefPubMedPubMedCentral
26.
Tubeuf S, Edlin R, Shourie S, Cheater FM, Bekker H, Jackson C. Cost effectiveness of a web-based decision aid for parents deciding about MMR vaccination: a three-arm cluster randomised controlled trial in primary care. Br J Gen Pract. 2014;64(625):e493-499.CrossRefPubMedPubMedCentral
27.
Levine G, Salifu A, Mohammed I, Fink G. Mobile nudges and financial incentives to improve coverage of timely neonatal vaccination in rural areas (GEVaP trial): A 3-armed cluster randomized controlled trial in Northern Ghana. PLoS ONE. 2021;16(5):e0247485.CrossRefPubMedPubMedCentral
28.
29.
Fu LY, Bonhomme LA, Cooper SC, Joseph JG, Zimet GD. Educational interventions to increase HPV vaccination acceptance: a systematic review. Vaccine. 2014;32(17):1901–20.CrossRefPubMedPubMedCentral
30.
Larkey LK, Hecht M. A model of effects of narrative as culture-centric health promotion. J Health Commun. 2010;15(2):114–35.CrossRefPubMed
31.
Hopfer S, Clippard JR. College women’s HPV vaccine decision narratives. Qual Health Res. 2011;21(2):262–77.CrossRefPubMed
32.
Wilson K, Atkinson KM, Penney G. Development and release of a national immunization app for Canada (ImmunizeCA). Vaccine. 2015;33(14):1629–32.CrossRefPubMed
33.
Feemster KA, Head KJ, Panozzo CA, O’Dell SM, Zimet GD, Kornides ML. Efficacy of tailored messages to improve behavioral intent to accept HPV vaccination among mothers may be moderated by sociodemographics. Prev Med Rep. 2021;23:101413.CrossRefPubMedPubMedCentral
34.
Myers A, Ipsen C, Lissau A. COVID-19 vaccination hesitancy among Americans with disabilities aged 18–65: An exploratory analysis. Disabil Health J. 2022;15(1):101223.CrossRefPubMed
35.
Kerns EK, Staggs VS, Fouquet SD, McCulloh RJ. Estimating the impact of deploying an electronic clinical decision support tool as part of a national practice improvement project. J Am Med Inform Assoc. 2019;26(7):630–6.CrossRefPubMedPubMedCentral
36.
37.
McCulloh RJ, Fouquet SD, Herigon J, Biondi EA, Kennedy B, Kerns E, DePorre A, Markham JL, Chan YR, Nelson K, Newland JG. Development and implementation of a mobile device-based pediatric electronic decision support tool as part of a national practice standardization project. J Am Med Inform Assoc. 2018;25(9):1175–82.CrossRefPubMedPubMedCentral
38.
Roberts JR, Morella K, Dawley EH, et al. Direct-to-adolescent text messaging for vaccine reminders: What will parents permit? Vaccine. 2018;36(20):2788–93.CrossRefPubMedPubMedCentral
39.
Carney PA, Hatch B, Stock I, et al. A stepped-wedge cluster randomized trial designed to improve completion of HPV vaccine series and reduce missed opportunities to vaccinate in rural primary care practices. Implement Sci. 2019;14(1):30.CrossRefPubMedPubMedCentral
40.
Taylor JA, Darden PM, Brooks DA, Hendricks JW, Wasserman RC, Bocian AB. Association between parents’ preferences and perceptions of barriers to vaccination and the immunization status of their children: a study from Pediatric Research in Office Settings and the National Medical Association. Pediatrics. 2002;110(6):1110–6.CrossRefPubMed
41.
Detoc M, Launay O, Dualé C, et al. Barriers and motivations for participation in preventive vaccine clinical trials: Experience of 5 clinical research sites. Vaccine. 2019;37(44):6633–9.CrossRefPubMed
42.
43.
44.
45.
46.
Hesitancy SWGoV. Report of the Sage Working Group on Vaccine Hesitancy. 2014.
47.
Usability Evaluation In Industry. 1 ed. London, UK: CRC Press; 1996.
48.
49.
50.
Southwell BG, Niederdeppe J, Cappella JN, et al. Misinformation as a misunderstood challenge to public health. Am J Prev Med. 2019;57(2):282–5.CrossRefPubMed
51.
52.
53.
Fadda M, Galimberti E, Fiordelli M, Romanò L, Zanetti A, Schulz PJ. Effectiveness of a smartphone app to increase parents’ knowledge and empowerment in the MMR vaccination decision: A randomized controlled trial. Hum Vaccin Immunother. 2017;13(11):2512–21.
54.
Shourie S, Jackson C, Cheater FM, Bekker HL, Edlin R, Tubeuf S, Harrison W, McAleese E, Schweiger M, Bleasby B, Hammond L. A cluster randomised controlled trial of a web based decision aid to support parents’ decisions about their child’s Measles Mumps and Rubella (MMR) vaccination. Vaccine. 2013;31(50):6003–10.
55.
Kempe A, Stockwell MS, Szilagyi P. The Contribution of Reminder-Recall to Vaccine Delivery Efforts: A Narrative Review. Acad Pediatr. 2021;21(4s):S17-s23.CrossRefPubMed
56.
de Cock C, van Velthoven M, Milne-Ives M, Mooney M, Meinert E. Use of Apps to Promote Childhood Vaccination: Systematic Review. JMIR Mhealth Uhealth. 2020;8(5):e17371.
57.
58.
Metadata
Title
Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial
Authors
Russell J. McCulloh
Paul M. Darden
Jessica Snowden
Songthip Ounpraseuth
Jeannette Lee
Martina Clarke
Sophia R. Newcomer
Linda Fu
DeAnn Hubberd
Jaime Baldner
Maryam Garza
Ellen Kerns
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06819-3

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue

Study protocol

Effects of transcranial direct current stimulation on patients with post-stroke fatigue: a study protocol for a double-blind randomized controlled trial

Study protocol

PolyMyalgia Rheumatica treatment with Methotrexate in Optimal Dose in an Early disease phase (PMR MODE): study protocol for a multicenter double-blind placebo controlled trial

Study protocol

A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary syndrome: study protocol for the TIGER STUDY

Methodology

A novel Bayesian adaptive design incorporating both primary and secondary endpoints for randomized IIB chemoprevention study of women at increased risk for breast cancer

Study protocol

Effects of acupuncture treatment on postoperative gastrointestinal dysfunction in colorectal cancer: study protocol for randomized controlled trials

Study protocol

Ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arresT (PROTECT): study protocol for a randomized, placebo-controlled trial