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Clinical trial

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

ID
Name
SunYat-senU20230908
Description
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.
Trial arms
Trial start
2023-09-11
Estimated PCD
2024-06-30
Trial end
2024-06-30
Status
Recruiting
Treatment
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.
Arms:
Intervention
Size
3036
Primary endpoint
influenza vaccination rate
Within 20 weeks from enrollment
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Outcomes Assessor will not know the intervention status of the participants.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 3036, 'type': 'ESTIMATED'}}
Updated at
2024-02-21

1 organization

1 product

2 indications

Organization
Sun Yat-sen University
Product
Health education
Indication
Vaccination
Indication
Influenza