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临床试验/NCT06048406
NCT06048406Unknown不适用

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

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 3,036 人开始时间: 2023年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
3,036
试验地点
1
主要终点
influenza vaccination rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes Assessor will not know the intervention status of the participants.

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Intervention

Experimental

The intervention group will receive a monthly health education intervention focused on influenza vaccination literacy for 5 months.

干预措施: Health education (Combination Product)

Control

No Intervention

The control group will continue with their routine school health education for 5 months.

结局指标

主要结局

influenza vaccination rate

时间窗: Within 20 weeks from enrollment

he influenza vaccination rate will be calculated as the number of vaccinated individuals divided by the total number of individuals, multiplied by 100%.

次要结局

  • influenza vaccine protection rate(Within 20 weeks from enrollment)
  • influenza incidence(Within 20 weeks from enrollment)
  • influenza-like illness incidence(Within 20 weeks from enrollment)
  • influenza vaccination health literacy level(Within 20 weeks from enrollment)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin Xu

Professor

Sun Yat-sen University

研究点 (1)

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