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Clinical Trials/ACTRN12621000463875
ACTRN12621000463875
Completed
未知

The effect of a multi-component intervention targeting influenza vaccination uptake in children and adolescents with special risk medical conditions at the provider and parent levels: a randomised controlled trial.

Women's and Children's Health Network0 sites619 target enrollmentApril 20, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Influenza
Sponsor
Women's and Children's Health Network
Enrollment
619
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Parents (of children aged 6 months to 18 years with Special Risk Medical Conditions (SRMC)) were enrolled from April 15th to August 13th, 2021, and randomised (1:1 ratio) to standard care or intervention, stratified by age-group (<5, 5-14, >14- <18 years). The primary outcome was influenza vaccination, confirmed by the AIR. There were a total of 18 sub-specialty doctors involved in the implementation of the study from one of six specialty departments at the Women's and Children's Hospital (diabetes/endocrine, neurology, respiratory, rheumatology, cardiology and gastroenterology). Over the intervention period (April to end August), a total of 2831 children were screened for a medical condition recognised by the Australian Immunisation Handbook as being eligible for free influenza vaccination regardless of age. Of these children, 619 were randomised to the two treatment groups and 2212 were ineligible according to protocol exclusions. A total of 600 participants were included in the statistical analysis (standard=302; mean age 11.4 years; intervention=298; mean age 11.5 years. Flutext-4U intervention participants had higher influenza vaccine receipt (38.6%), compared to participants receiving standard care. In this study, among children and adolescents with SRMC at a paediatric tertiary hospital, a multicomponent intervention that included a parent SMS message was superior to standard care and resulted in more timely influenza vaccine receipt.

Registry
who.int
Start Date
April 20, 2021
End Date
December 17, 2021
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Women's and Children's Health Network

Eligibility Criteria

Inclusion Criteria

  • Sub\-specialists \& GPs:
  • All medical practitioners working under the diabetes, neurology, respiratory, gastroenterology, rheumatology, cardiology sub\-specialties at the WCH and the child’s referring GP.
  • Each participant must meet all of the following criteria to be enrolled in this trial:
  • Parent of a child/adolescent with a special risk medical condition putting them at increased risk of serious influenza complications such as: heart disease or chronic lung conditions; severe asthma (those who need frequent GP visits or multiple medications); nervous system diseases, which may affect breathing, e.g. Multiple Sclerosis; diabetes or kidney disease; lowered immunity, either due to disease or treatment, e.g. cancer or rheumatoid arthritis treatment; certain blood disorders; and children taking aspirin long term.
  • Have a WCH outpatient appointment with sub\- specialities: diabetes, neurology, respiratory, gastroenterology, rheumatology or cardiology between April and the end of July 2021\.

Exclusion Criteria

  • Patients meeting any of the following criteria will be excluded from the trial:
  • Previous receipt of influenza vaccine in 2021, prior to trial commencement (defined as receipt on AIR).
  • Younger sibling of another trial participant (to ensure parents are not randomised twice).
  • No listed mobile phone number for parent / guardian on WCH patient registration.
  • New patients without a confirmed special risk medical condition diagnosis.
  • Children or adolescents with a diagnosis of Cystic Fibrosis. These children already receive additional vaccine delivery support and influenza vaccine messaging within the WCH environment.

Outcomes

Primary Outcomes

Not specified

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