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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02883972
Other study ID # 2016_FluInvSch
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date April 2017

Study information

Verified date July 2016
Source Public Health England
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 11 Years
Eligibility Inclusion Criteria: - Attendance at a school where national childhood influenza immunisation programme is delivered by a provider participating in the trial - Eligible for influenza immunisation Exclusion Criteria: - Ineligible for influenza immunisation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Public Health England

Outcome

Type Measure Description Time frame Safety issue
Primary 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 5 months
Secondary Influenza immunisation uptake in school years 4-6 Proportion of children in school years 4-6 who receive influenza immunisation 5 months
Secondary Influenza immunisation uptake in Reception school year Proportion of children in Reception school year who receive influenza immunisation 5 months
Secondary Influenza immunisation uptake in each school year Proportion of children in each school year who receive influenza immunisation 5 months
Secondary 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) 5 months
Secondary 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) 5 months
Secondary 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) 5 months
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