search
Back to results

Effect of Health Education on Promoting Influenza Vaccination Health Literacy

Primary Purpose

Vaccination; Infection, Influenza

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Health education
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vaccination; Infection focused on measuring health education, health literacy, schools, China

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dongguang Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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%.
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.

Secondary Outcome Measures

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%
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%.
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%.

Full Information

First Posted
September 8, 2023
Last Updated
September 27, 2023
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT06048406
Brief Title
Effect of Health Education on Promoting Influenza Vaccination Health Literacy
Official Title
Effect of Health Education on Promoting Influenza Vaccination Health Literacy Among Primary School Students
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination; Infection, Influenza
Keywords
health education, health literacy, schools, China

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor will not know the intervention status of the participants.
Allocation
Randomized
Enrollment
3036 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group will receive a monthly health education intervention focused on influenza vaccination literacy for 5 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will continue with their routine school health education for 5 months.
Intervention Type
Combination Product
Intervention Name(s)
Health education
Intervention Description
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.
Primary Outcome Measure Information:
Title
influenza vaccination rate
Description
he influenza vaccination rate will be calculated as the number of vaccinated individuals divided by the total number of individuals, multiplied by 100%.
Time Frame
Within 20 weeks from enrollment
Title
influenza vaccination health literacy level
Description
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.
Time Frame
baseline and 20 weeks
Secondary Outcome Measure Information:
Title
influenza incidence
Description
The influenza incidence will be calculated as the number of individuals diagnosed with influenza divided by the total number of individuals, multiplied by 100%
Time Frame
Within 20 weeks from enrollment
Title
influenza vaccine protection rate
Description
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%.
Time Frame
Within 20 weeks from enrollment
Title
influenza-like illness incidence
Description
The ILI incidence will be calculated as the number of ILI cases divided by the total number of participants, multiplied by 100%.
Time Frame
Within 20 weeks from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Xu, PhD
Phone
86-20-87335523
Email
shellylxu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Jingyi, Master
Phone
+86-13602477650
Email
jychen0501@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Xu, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguang Center for Disease Control and Prevention
City
Dongguang
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Xu, PhD
Phone
+8613602477650
Email
xulin27@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Health Education on Promoting Influenza Vaccination Health Literacy

We'll reach out to this number within 24 hrs