Influenza, HumanNCT02883972
Childhood Influenza Immunisation Invitation Trial in Schools
A study testing Intervention letter and Reminder in people with Influenza, Human, run by Public Health England.
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. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Intervention letter and Reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attendance at a school where national childhood influenza immunisation programme is delivered by a provider participating in the trial
- Eligible for influenza immunisation
Who cannot join
- Ineligible for influenza immunisation
About this study
Official title: Can Uptake of Childhood Influenza Immunisation Through Schools be Increased Through Behavioural-insight Informed Changes to the Invitation Process?
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.
Read the detailed 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.
- Conditions
- Influenza, Human
- Being tested
- Intervention letter, Control letter, Reminder
- Keywords
- Immunization, Behavioural insights, Children
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention letterOther
Behavioural-insight informed letter template
Control letterOther
Invitation letter used by local area last year (updated as required)
ReminderOther
Behavioural-insight informed SMS/email reminder message to return consent form
| Study group | Role | What they receive |
|---|---|---|
| Intervention letter and reminder | Experimental | Behavioural insights informed invitation letter and SMS/email reminder message Receives: Other: Intervention letter; Other: Reminder |
| Intervention letter | Experimental | Behavioural insights informed invitation letter only Receives: Other: Intervention letter |
| Control letter and reminder | Experimental | Control invitation letter and SMS/email reminder message Receives: Other: Control letter; Other: Reminder |
| Control letter | Active comparator | Control invitation letter only Receives: Other: Control letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months
Secondary outcomes (6)
Influenza immunisation uptake in school years 4-6
Proportion of children in school years 4-6 who receive influenza immunisation
Measured: 5 months
Influenza immunisation uptake in Reception school year
Proportion of children in Reception school year who receive influenza immunisation
Measured: 5 months
Influenza immunisation uptake in each school year
Proportion of children in each school year who receive influenza immunisation
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017
- Study completionApr 2017
Why it stopped: Ethical approval was withdrawn by the National Research Ethics Service as they were unable to make contact with the research team despite trying many times.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tim Chadborn, BSc MSc PhD, Principal investigator, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883972
- Sponsor's protocol ID
- 2016_FluInvSch
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36670376
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Uptake of Childhood Influenza Immunisation Through Schools be Increased Through Behavioural-insight Informed Changes to the Invitation Process?
- ClinicalTrials.gov ID
- NCT02883972
- Acronym / sponsor ID
- 2016_FluInvSch
- Conditions
- Influenza, Human
- Keywords
- Immunization, Behavioural insights, Children
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ethical approval was withdrawn by the National Research Ethics Service as they were unable to make contact with the research team despite trying many times.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention letter and reminder | Experimental | Other: Intervention letter, Other: ReminderBehavioural insights informed invitation letter and SMS/email reminder message |
| Intervention letter | Experimental | Other: Intervention letterBehavioural insights informed invitation letter only |
| Control letter and reminder | Experimental | Other: Control letter, Other: ReminderControl invitation letter and SMS/email reminder message |
| Control letter | Active comparator | Other: Control letterControl invitation letter only |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Attendance at a school where national childhood influenza immunisation programme is delivered by a provider participating in the trial
- Eligible for influenza immunisation
Key exclusion criteria (1 listed)
- Ineligible for influenza immunisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention letterBehavioural-insight informed letter template | Other | Intervention letter, Intervention letter and reminder |
| Control letterInvitation letter used by local area last year (updated as required) | Other | Control letter, Control letter and reminder |
| ReminderBehavioural-insight informed SMS/email reminder message to return consent form | Other | Control letter and reminder, Intervention letter and reminder |
Primary outcome
Influenza immunisation uptake in school years 1-3
Time frame: 5 months
Proportion of children in school years 1-3 who receive influenza immunisation as part of the national childhood immunisation programme
6 secondary outcomes
Influenza immunisation uptake in school years 4-6
Time frame: 5 months
Influenza immunisation uptake in Reception school year
Time frame: 5 months
Influenza immunisation uptake in each school year
Time frame: 5 months
Influenza immunisation consent in school years 1-3
Time frame: 5 months
Influenza immunisation consent in school years 4-6
Time frame: 5 months
Influenza immunisation consent in Reception school year
Time frame: 5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 36670376Howell-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Chadborn, BSc MSc PhD principal investigator
Public Health England
Questions about this trial
What is this clinical trial studying?
A study testing Intervention letter and Reminder in people with Influenza, Human, run by Public Health England.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza immunisation uptake in school years 1-3 (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.