An interventional study of Intervention letter and Control letter in Influenza, Human, sponsored by Public Health England. Withdrawn. Open to participants aged 4 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Public Health England · Not applicable, Interventional, and Other
This study will investigate whether influenza vaccine uptake by school-age children (in school-based clinics) can be increased by making behavioural-insight informed changes to the invitation process which encourage parents to return consent forms.
Previous research has shown that small changes to the invitation phrasing and/or process informed by understanding and insights into behaviour can be used to increase a desired behaviour (e.g. uptake of health checks, reducing primary care antibiotic prescribing).
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.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
Browse Influenza, Human studies →Public Health England is the lead sponsor of 37 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Behavioural insights informed invitation letter and SMS/email reminder message
Other: Intervention letter · Other: Reminder
Behavioural insights informed invitation letter only
Other: Intervention letter
Control invitation letter and SMS/email reminder message
Other: Control letter · Other: Reminder
Control invitation letter only
Other: Control letter
Behavioural-insight informed letter template
Invitation letter used by local area last year (updated as required)
Behavioural-insight informed SMS/email reminder message to return consent form
Influenza immunisation uptake in school years 1-3
Proportion of children in school years 1-3 who receive influenza immunisation as part of the national childhood immunisation programme
Time frame: 5 months
Influenza immunisation uptake in school years 4-6
Proportion of children in school years 4-6 who receive influenza immunisation
Time frame: 5 months
Influenza immunisation uptake in Reception school year
Proportion of children in Reception school year who receive influenza immunisation
Time frame: 5 months
Influenza immunisation uptake in each school year
Proportion of children in each school year who receive influenza immunisation
Time frame: 5 months
Influenza immunisation consent in school years 1-3
Proportion of children in school years 1-3 for who consent is neither given nor withheld (i.e. non-responders)
Time frame: 5 months
Influenza immunisation consent in school years 4-6
Proportion of children in school years 4-6 for who consent is neither given nor withheld (i.e. non-responders)
Time frame: 5 months
Influenza immunisation consent in Reception school year
Proportion of children in Reception school year for who consent is neither given nor withheld (i.e. non-responders)
Time frame: 5 months
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2016 to primary completion in Mar 2017, 6 months.
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This study is withdrawn, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Public Health England