Promoting Altruism to Enhance Vaccine Acceptance
Cohort Study to Determine the Effect of an Educational Intervention Focusing on Herd Immunity to Enhance Vaccination Uptake Rates
1 other identifier
interventional
510
1 country
1
Brief Summary
Subjects enrolled in this study are eligible for the seasonal influenza vaccine. The purpose of this research study is to figure out if increasing individuals' awareness of the benefits of herd immunity, specifically to the local pediatric oncology community, can improve vaccination uptake rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedStudy Start
First participant enrolled
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2021
CompletedResults Posted
Study results publicly available
August 12, 2024
CompletedAugust 12, 2024
July 1, 2022
1 year
September 17, 2020
October 13, 2022
March 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Vaccine Hesitancy Scores Pre- and Post-Intervention.
8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant.
Baseline (Pre-intervention) and Post-Intervention, up to 4 hours
Pre-Intervention Vaccine Hesitancy Score
8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant.
baseline
Post-Intervention Vaccine Hesitancy Score
8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant.
Post-Intervention up to 4 Hours
Secondary Outcomes (2)
Rate of Influenza Vaccine Uptake
baseline
Pre-Intervention Altruism Scale
baseline
Other Outcomes (1)
Complex Interaction Interviews
Month 9
Study Arms (1)
Vaccine Hesitant
EXPERIMENTALSubjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention.
Interventions
If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script.
Eligibility Criteria
You may qualify if:
- All legal guardians of children aged 6 months and up who are influenza vaccine-eligible and present to the pediatric clinic.
You may not qualify if:
- Legal guardians of children who are not influenza vaccine-eligible including children less than 6 months of age, children on immunosuppressive medications, and children with underlying medical conditions resulting in an immunocompromised state.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest Univesity Health Sciences
Winston-Salem, North Carolina, 27157, United States
Related Publications (1)
Marlowe E, Pranikoff S, Borsheim B, Salafian K, Halvorson EE, Kram DE. Pilot study to determine effect of an altruism intervention focusing on herd immunity to enhance influenza vaccination rates. Vaccine. 2022 Nov 2;40(46):6625-6630. doi: 10.1016/j.vaccine.2022.09.074. Epub 2022 Oct 6.
PMID: 36210252DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elizabeth Halvorson, MD, MS
- Organization
- Wake Forest University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Halvorson, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2020
First Posted
September 29, 2020
Study Start
October 19, 2020
Primary Completion
October 26, 2021
Study Completion
October 26, 2021
Last Updated
August 12, 2024
Results First Posted
August 12, 2024
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- All data will be available beginning 9 months and ending 36 months following article publication.
- Access Criteria
- Please contact PI to request access to data beginning 9 months and ending 36 months after article publication.
All of the individual participant data collected during the trial, after deidentification, will be available. The Study Protocol, Statistical Analysis Plan, and Informed Consent Form will also be available. All data will be available beginning 9 months and ending 36 months following article publication. The study team intends to share with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication.