NCT02883972

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 25, 2023

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

July 22, 2016

Last Update Submit

April 21, 2023

Conditions

Influenza, Human

Keywords

ImmunizationBehavioural insightsChildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Influenza immunisation uptake in school years 4-6

    5 months

  • Influenza immunisation uptake in Reception school year

    5 months

  • Influenza immunisation uptake in each school year

    5 months

  • Influenza immunisation consent in school years 1-3

    5 months

  • Influenza immunisation consent in school years 4-6

    5 months

  • +1 more secondary outcomes

Study Arms (4)

Intervention letter and reminder

EXPERIMENTAL

Behavioural insights informed invitation letter and SMS/email reminder message

Other: Intervention letterOther: Reminder

Intervention letter

EXPERIMENTAL

Behavioural insights informed invitation letter only

Other: Intervention letter

Control letter and reminder

EXPERIMENTAL

Control invitation letter and SMS/email reminder message

Other: Control letterOther: Reminder

Control letter

ACTIVE COMPARATOR

Control invitation letter only

Other: Control letter

Interventions

Intervention letterOTHER

Behavioural-insight informed letter template

Intervention letterIntervention letter and reminder
Control letterOTHER

Invitation letter used by local area last year (updated as required)

Control letterControl letter and reminder
ReminderOTHER

Behavioural-insight informed SMS/email reminder message to return consent form

Control letter and reminderIntervention letter and reminder

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Attendance at a school where national childhood influenza immunisation programme is delivered by a provider participating in the trial
  • Eligible for influenza immunisation

You may not qualify if:

  • Ineligible for influenza immunisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36670376DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Tim Chadborn, BSc MSc PhD

    Public Health England

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 30, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

April 25, 2023

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share