Effect of Health Education on Promoting Influenza Vaccination Health Literacy

• ClinicalTrials.gov Identifier: NCT06048406
• Recruitment Status: Recruiting
• First Posted: September 21, 2023
• Last Update Posted: February 21, 2024
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Lin Xu, Sun Yat-sen University

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.

Condition or disease	Intervention/treatment	Phase
Vaccination; Infection; Influenza	Combination Product: Health education	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 3036 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcomes Assessor will not know the intervention status of the participants.
• Primary Purpose: Health Services Research
• Official Title: Effect of Health Education on Promoting Influenza Vaccination Health Literacy Among Primary School Students
• Actual Study Start Date: September 11, 2023
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; The intervention group will receive a monthly health education intervention focused on influenza vaccination literacy for 5 months.	Combination Product: Health education; 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.
No Intervention: Control; The control group will continue with their routine school health education for 5 months.

Outcome Measures

Primary Outcome Measures :

1. influenza vaccination rate [ Time Frame: 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%.

Secondary Outcome Measures :

1. influenza vaccination health literacy level [ Time Frame: Within 20 weeks from enrollment ]
   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.
2. influenza incidence [ Time Frame: Within 20 weeks from enrollment ]
   The influenza incidence will be calculated as the number of individuals diagnosed with influenza divided by the total number of individuals, multiplied by 100%
3. influenza vaccine protection rate [ Time Frame: Within 20 weeks from enrollment ]
   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%.
4. influenza-like illness incidence [ Time Frame: Within 20 weeks from enrollment ]
   The ILI incidence will be calculated as the number of ILI cases divided by the total number of participants, multiplied by 100%.

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Lin Xu, PhD; 86-20-87335523; shellylxu@gmail.com

Contact: Chen Jingyi, Master; +86-13602477650; jychen0501@163.com

Locations

China, Guangdong

Dongguang Center for Disease Control and Prevention; Recruiting

Dongguang, Guangdong, China, 510000

Contact: Lin Xu, PhD +8613602477650 xulin27@mail.sysu.edu.cn

Sponsors and Collaborators

Sun Yat-sen University

Investigators

• Principal Investigator: Lin Xu, PhD; Sun Yat-sen University

  Study Documents (Full-Text)

Documents provided by Lin Xu, Sun Yat-sen University:

Study Protocol and Statistical Analysis Plan  [PDF] September 1, 2023

More Information

• Responsible Party: Lin Xu, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT06048406
• Other Study ID Numbers: SunYat-senU20230908
• First Posted: September 21, 2023
• Last Update Posted: February 21, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lin Xu, Sun Yat-sen University:

health education; health literacy; schools; China

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases