Promoting Altruism to Enhance Vaccine Acceptance

NCT ID: NCT04568590

Last Updated: 2024-08-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2021-10-26

Brief Summary

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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.

Detailed Description

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The purpose of this study is to identify associations with influenza vaccine hesitancy, including parental demographics and altruism score, in families with healthy children attending two pediatric practices.

Also, in the cohort of families with baseline vaccine hesitancy, to assess the effectiveness of a pilot educational intervention focusing on the development of herd immunity for pediatric oncology patients by measuring:

1. The change in vaccine hesitancy scores pre- and post-intervention.
2. The rate of influenza vaccine uptake compared to historic controls from previous influenza seasons.

Another aim is to explore the relationship between baseline influenza vaccine hesitancy rates and baseline altruism scores. Effectiveness of this intervention is dependent on parental altruism levels; therefore, the study team also seeks to determine if there is an association between parental altruism and vaccine hesitancy for their children.

This is a single-arm prospective cohort study. The study will enroll legal guardians of children who are influenza vaccine-eligible to measure their vaccine hesitancy scores, altruism scores, and the impact of an educational intervention focused on herd immunity on the guardians' vaccine hesitancy score.

Conditions

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Vaccine Refusal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Vaccine Hesitant

Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention.

Group Type EXPERIMENTAL

educational intervention

Intervention Type BEHAVIORAL

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.

Interventions

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educational intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All legal guardians of children aged 6 months and up who are influenza vaccine-eligible and present to the pediatric clinic.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Halvorson, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Univesity Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36210252 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00068446

Identifier Type: -

Identifier Source: org_study_id

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