Effect of Health Education on Promoting Influenza Vaccination Health Literacy

Study Overview
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Brief Summary
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The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on influenza vaccination rates and health literacy in primary school students in the city of Dongguan in China. Individuals aged 7 to 12 years who are in grades 4-5 in primary schools in Dongguan will be enrolled. 20 primary schools will be randomly selected, with half designated as intervention group schools and the remaining half as control group schools. The intervention group will receive a monthly health education intervention focused on influenza vaccination for 5 months, while the control group will continue with their routine school health education for 5 months. Researchers will compare the differences in influenza vaccination rates and influenza vaccination health literacy levels between the intervention and control groups after 5 months to see if health education can promote influenza vaccination health literacy among primary school students.

Detailed Description
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Introduction: Influenza is a major public health threat, and vaccination is the most effective prevention method. However, vaccination coverage remains suboptimal. Low health literacy regarding influenza vaccination may contribute to vaccine hesitancy. This study aims to evaluate the effect of health education interventions on influenza vaccination rates and health literacy. Methods and analysis: This cluster randomized controlled trial will enroll 3036 students in grades 4-5 from 20 primary schools in Dongguan City, China. Schools will be randomized to an intervention group receiving influenza vaccination health education or a control group receiving routine health education. The primary outcome is influenza vaccination rate. Secondary outcomes include health literacy levels, influenza diagnosis rate, influenza-like illness incidence, and vaccine protection rate. Data will be collected through questionnaires, influenza surveillance, and self-reports at baseline and study conclusion. Ethics and dissemination: Ethical approval has been sought from the Ethics Committee of the School of Public Health, Sun Yat-sen University. Findings from the study will be made accessible to both peer-reviewed journals and key stakeholders.

Official Title
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Effect of Health Education on Promoting Influenza Vaccination Health Literacy Among Primary School Students

Conditions
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Vaccination; Infection, Influenza

Intervention / Treatment
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* Combination Product: Health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary school students within the age range of 7-12 years. Students and their parents who voluntarily agree to participate in the study and provide signed informed consent. Permanent residents of Dongguan City who are expected to complete the project without transferring schools during the study period. Exclusion Criteria: Individuals with contraindications to influenza vaccination, who have recently received an influenza vaccination, diagnosed with influenza or confirmed as influenza-like cases at the commencement of the study. Unwilling to participate in the project.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group will receive a monthly health education intervention focused on influenza vaccination literacy for 5 months. | Combination Product: Health education<br>* The intervention group will receive a health education intervention focused on influenza vaccination literacy, while the control group will continue with their standard school health education without any additional intervention. An influenza vaccination health education including topics such as the importance of influenza vaccination, benefits of vaccination, and vaccination methods, will be developed and reviewed by an expert group. The package for the intervention group will include educational activities, distribution of promotional materials, vaccination services, and distribution of vaccination souvenirs.<br>|
| No Intervention: Control<br>The control group will continue with their routine school health education for 5 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influenza vaccination rate | he influenza vaccination rate will be calculated as the number of vaccinated individuals divided by the total number of individuals, multiplied by 100%. | Within 20 weeks from enrollment | 
| influenza vaccination health literacy level | Regarding the influenza vaccination health literacy level, each correct answer for the health literacy research questionnaire will be scored as one point, with incorrect answers receiving no points. Based on the scores, health literacy levels will be categorized as low, medium, or high. | baseline and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influenza incidence | The influenza incidence will be calculated as the number of individuals diagnosed with influenza divided by the total number of individuals, multiplied by 100% | Within 20 weeks from enrollment | 
| influenza vaccine protection rate | The influenza vaccine protection rate will be calculated as the difference between the incidence rate in unvaccinated individuals and the incidence rate in vaccinated individuals, divided by the incidence rate in unvaccinated individuals, multiplied by 100%. | Within 20 weeks from enrollment | 
| influenza-like illness incidence | The ILI incidence will be calculated as the number of ILI cases divided by the total number of participants, multiplied by 100%. | Within 20 weeks from enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health education, health literacy, schools, China