Promoting Altruism to Enhance Vaccine Acceptance

Not Applicable

Completed

• Conditions: Vaccine Refusal
• Interventions: Behavioral: educational intervention

• Registration Number: NCT04568590
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Study Start: 2020-10-19
• Primary Completion: 2021-10-26
• Study Completion: 2021-10-26
• Status Verified: 2022-07
• Results First Submitted: 2022-10-13
• Results First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Results First Posted: 2024-08-12
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine Hesitant	educational intervention	Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention.

Primary Outcome Measures

Name	Time	Method
Change in Vaccine Hesitancy Scores Pre- and Post-Intervention.	Baseline (Pre-intervention) and Post-Intervention, up to 4 hours	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.
Pre-Intervention Vaccine Hesitancy Score	baseline	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 Vaccine Hesitancy Score	Post-Intervention up to 4 Hours	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Influenza Vaccine Uptake	baseline	The subject's child's electronic health record will be accessed to document whether that patient received the seasonal influenza vaccine during the baseline visit.
Pre-Intervention Altruism Scale	baseline	Scale ranges from 20-100 with a higher score denoting higher altruism.

Trial Locations

Locations (1)

Wake Forest Univesity Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States