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Trial registered on ANZCTR


Registration number
ACTRN12618000636257
Ethics application status
Approved
Date submitted
12/04/2018
Date registered
23/04/2018
Date last updated
29/04/2019
Date data sharing statement initially provided
29/04/2019
Date results information initially provided
29/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact of short automated text message reminder system in improving influenza vaccine uptake in children with chronic lung conditions: a randomised controlled trial
Scientific title
Investigating the impact of short automated text message reminder system in improving influenza vaccine uptake in children with chronic lung conditions: a randomised controlled trial
Secondary ID [1] 294577 0
None
Universal Trial Number (UTN)
U1111-1212-2492
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 307360 0
Congenital diaphragmatic hernia 307361 0
Trachea-oesophageal fistula 307362 0
non-CF bronchiectasis 307363 0
Condition category
Condition code
Respiratory 306469 306469 0 0
Asthma
Respiratory 306470 306470 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions involve an education flyer and SMS text reminder. Parents of children aged between 6 months and 18 years with chronic lung diseases, including asthma, non-CF bronchiectasis, trachea-oesophageal fistula and congenital diaphragmatic hernia, will be randomly assigned into 3 groups (i.e. 2 interventions and one control group.).
Both intervention groups will receive an education flyer advising them to vaccinate their children. The flyer, adapted from the "Flu card" of the Centres for Disease Control and Prevention, includes general information about influenza (i.e. signs and symptoms) and flu vaccine, and the importance of vaccinating children with chronic lung diseases as they are at risk of developing serious complications, One of the intervention groups will receive additional SMS text reminder message twice a month for 6 months from 1 May 2018 to 31 October 2018. The SMS text reminder reads as
"XX’s (child’s name) doctor at Sydney Children’s Hospital recommends that XX receives the flu shot every year. The flu shot can protect your child’s health by reducing the risk of serious complications from flu. Remember it’s time for XX to take this year’s flu shot. Please take XX to your doctor to have a flu shot as soon as possible".
Intervention code [1] 300868 0
Prevention
Comparator / control treatment
Control group will not receive any education flyer or text reminder message.
Control group
Active

Outcomes
Primary outcome [1] 305477 0
An online survey, which is designed specially for this study, will be sent to both interventions and control groups. The percentage of participants who have their children immunized against influenza will be compared among the three groups.
Timepoint [1] 305477 0
The online survey will be distributed to all 3 study groups on 1 November 2018.
Secondary outcome [1] 345383 0
Parental attitude towards influenza vaccination will be assessed by the same online survey as mentioned above for the primary outcome, which is designed specifically for this study.
Timepoint [1] 345383 0
The online survey will be distributed to all 3 study groups on 1 November 2018.
Secondary outcome [2] 345672 0
Parental attitude towards the text reminder message will be assessed by the same online survey as mentioned above for the primary outcome, which is designed specifically for this study.
Timepoint [2] 345672 0
The online survey will be distributed to all 3 study groups on 1 November 2018.
Secondary outcome [3] 345687 0
Parental attitude towards the education flyer will be assessed by the same online survey as mentioned above for the primary outcome, which is designed specifically for this study.
Timepoint [3] 345687 0
The online survey will be distributed to all 3 study groups on 1 November 2018.

Eligibility
Key inclusion criteria
Parents of children attending the High Risk Asthma Clinic, Trachea-oesophageal Fistula, and Congenital Diaphragmatic Hernia Clinic at the Sydney Children's Hospital. during 2010-2016 for clinical care.
Minimum age
6 Months
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents of children with cystic fibrosis or without a valid contact address and number;
those who do not have access to a smart phone or do not understand English will not be included

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization using a computer randomization program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design with a block size of 6.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analysis will be done using individual participant as unit of analysis. Differences in the frequency of influenza vaccine uptake and self-reported reasons for declining influenza vaccination will be assessed using chi-square exact tests and relative rates of influenza vaccination with confidence intervals will be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10631 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 22350 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 299194 0
Charities/Societies/Foundations
Name [1] 299194 0
Rotary Club of Sydney Cove
Address [1] 299194 0
Circular Quay
Eastern Pontoon
Sydney NSW 2000
Country [1] 299194 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Rotary Club of Sydney Cove
Address
Circular Quay
Eastern Pontoon
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 298457 0
None
Name [1] 298457 0
Address [1] 298457 0
Country [1] 298457 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300119 0
Sydney Children's Hospitals Network Ethics Committee
Ethics committee address [1] 300119 0
Children's Hospital at Westmead
Crn Hawkesbury Road and Hainsworth Street
Westmead 2145
NSW
Ethics committee country [1] 300119 0
Australia
Date submitted for ethics approval [1] 300119 0
22/01/2018
Approval date [1] 300119 0
14/03/2018
Ethics approval number [1] 300119 0
LNR/18/SCHN/31

Summary
Brief summary
Influenza vaccination coverage in children with chronic lung conditions has been poor in Australia. This study aims to find out whether text message reminder system is effective in improving influenza vaccination uptake in these children. Parents of children with chronic lung diseases who attended the Sydney Children's Hospital Randwick during 2010-16 will be recruited to participate in this study, which will be carried out between May and October 2018. Participants will be randomised into 3 groups i.e. one control and 2 intervention groups. For those in the intervention groups, they will receive an education flyer with information about influenza vaccination via postal mail at the beginning of the flu season. In addition,one of the intervention groups will receive vaccination reminder text message twice a month during the study period. No education flyer or text message will be sent to participants in the control arm. At the end of the study period, a link to an online survey will be delivered to all participants via text messages. Differences in influenza vaccination rate will be compared among the three groups using chi square exact tests and attitudes toward influenza vaccine and reminder system will be examined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82626 0
Dr Nusrat Homaira
Address 82626 0
Level 8, The Bright Alliance Building
Cnr Avoca and High Street
Randwick
NSW 2031
Country 82626 0
Australia
Phone 82626 0
+61 2 93825526
Fax 82626 0
Email 82626 0
n.homaira@unsw.edu.au
Contact person for public queries
Name 82627 0
Dr Nusrat Homaira
Address 82627 0
Level 8, The Bright Alliance Building
Cnr Avoca and High Street
Randwick
NSW 2031
Country 82627 0
Australia
Phone 82627 0
+61 2 93825526
Fax 82627 0
Email 82627 0
n.homaira@unsw.edu.au
Contact person for scientific queries
Name 82628 0
Dr Nusrat Homaira
Address 82628 0
Level 8, The Bright Alliance Building
Cnr Avoca and High Street
Randwick
NSW 2031
Country 82628 0
Australia
Phone 82628 0
+61 2 93825526
Fax 82628 0
Email 82628 0
n.homaira@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Insufficient funding
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary