Childhood Influenza Immunisation Invitation Trial in Schools
NCT ID: NCT02883972
Last Updated: 2023-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-09-30
2017-04-30
Brief Summary
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Detailed Description
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This trial will determine whether a behaviour-insight informed invitation letter and/or reminder Short Message Service (SMS)/email message can increase return of consent forms and thereby increase uptake of childhood flu vaccine in schools.
The trial will take place within the existing national childhood immunisation programme in participating areas in England. Randomisation will be at the school-level (stratified by local authority). All eligible children within a school will therefore be in the same arm of the trial and be subject to the same invitation process. Outcome data will be routinely collected, school-level influenza vaccine uptake data. Data will also be collected on the implementation of email/SMS reminders in all schools.
The analysis will investigate the main effects of the interventions and their interactions, take into account provider, local authority and school effects and explore the impact of other factors such as deprivation indicators.
An analysis of letters used by providers of childhood influenza immunisation in schools not involved in the trial will also be conducted. All providers will be asked to submit a copy of their invitation letter for the 2016/17 programme and these will be analysed using the Theoretical Domains Framework.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
NONE
Study Groups
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Intervention letter and reminder
Behavioural insights informed invitation letter and SMS/email reminder message
Intervention letter
Behavioural-insight informed letter template
Reminder
Behavioural-insight informed SMS/email reminder message to return consent form
Intervention letter
Behavioural insights informed invitation letter only
Intervention letter
Behavioural-insight informed letter template
Control letter and reminder
Control invitation letter and SMS/email reminder message
Control letter
Invitation letter used by local area last year (updated as required)
Reminder
Behavioural-insight informed SMS/email reminder message to return consent form
Control letter
Control invitation letter only
Control letter
Invitation letter used by local area last year (updated as required)
Interventions
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Intervention letter
Behavioural-insight informed letter template
Control letter
Invitation letter used by local area last year (updated as required)
Reminder
Behavioural-insight informed SMS/email reminder message to return consent form
Eligibility Criteria
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Inclusion Criteria
* Eligible for influenza immunisation
Exclusion Criteria
4 Years
11 Years
ALL
Yes
Sponsors
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Public Health England
OTHER_GOV
Responsible Party
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Principal Investigators
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Tim Chadborn, BSc MSc PhD
Role: PRINCIPAL_INVESTIGATOR
Public Health England
References
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Howell-Jones R, Gold N, Bowen S, Bunten A, Tan K, Saei A, Jones S, MacDonald P, Watson R, Bennett KF, Chadborn T. Can uptake of childhood influenza immunisation through schools and GP practices be increased through behaviourally-informed invitation letters and reminders: two pragmatic randomized controlled trials. BMC Public Health. 2023 Jan 20;23(1):143. doi: 10.1186/s12889-022-14439-4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016_FluInvSch
Identifier Type: -
Identifier Source: org_study_id
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