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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
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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
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Secondary ID [1]
294577
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None
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Universal Trial Number (UTN)
U1111-1212-2492
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
307360
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Congenital diaphragmatic hernia
307361
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Trachea-oesophageal fistula
307362
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non-CF bronchiectasis
307363
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Condition category
Condition code
Respiratory
306469
306469
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0
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Asthma
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Respiratory
306470
306470
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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".
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Intervention code [1]
300868
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Prevention
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Comparator / control treatment
Control group will not receive any education flyer or text reminder message.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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The online survey will be distributed to all 3 study groups on 1 November 2018.
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Secondary outcome [1]
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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.
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Assessment method [1]
345383
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Timepoint [1]
345383
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The online survey will be distributed to all 3 study groups on 1 November 2018.
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Secondary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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The online survey will be distributed to all 3 study groups on 1 November 2018.
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Secondary outcome [3]
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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.
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Assessment method [3]
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Timepoint [3]
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The online survey will be distributed to all 3 study groups on 1 November 2018.
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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.
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Minimum age
6
Months
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization using a computer randomization program.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design with a block size of 6.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
30/04/2018
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Actual
26/04/2018
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Date of last participant enrolment
Anticipated
13/05/2018
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Actual
31/05/2018
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Date of last data collection
Anticipated
30/11/2018
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Actual
1/12/2018
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Sample size
Target
600
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Accrual to date
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Final
69
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
10631
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Sydney Children's Hospital - Randwick
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Recruitment postcode(s) [1]
22350
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2031 - Randwick
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Funding & Sponsors
Funding source category [1]
299194
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Charities/Societies/Foundations
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Name [1]
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Rotary Club of Sydney Cove
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Address [1]
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Circular Quay
Eastern Pontoon
Sydney NSW 2000
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Country [1]
299194
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Rotary Club of Sydney Cove
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Address
Circular Quay
Eastern Pontoon
Sydney NSW 2000
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Country
Australia
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Secondary sponsor category [1]
298457
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None
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Name [1]
298457
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Address [1]
298457
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Country [1]
298457
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Children's Hospitals Network Ethics Committee
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Ethics committee address [1]
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Children's Hospital at Westmead
Crn Hawkesbury Road and Hainsworth Street
Westmead 2145
NSW
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Ethics committee country [1]
300119
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Australia
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Date submitted for ethics approval [1]
300119
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22/01/2018
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Approval date [1]
300119
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14/03/2018
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Ethics approval number [1]
300119
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LNR/18/SCHN/31
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Nusrat Homaira
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Address
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Level 8, The Bright Alliance Building
Cnr Avoca and High Street
Randwick
NSW 2031
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Country
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Australia
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Phone
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+61 2 93825526
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Fax
82626
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Nusrat Homaira
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Address
82627
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Level 8, The Bright Alliance Building
Cnr Avoca and High Street
Randwick
NSW 2031
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Country
82627
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Australia
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Phone
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+61 2 93825526
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Nusrat Homaira
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Address
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Level 8, The Bright Alliance Building
Cnr Avoca and High Street
Randwick
NSW 2031
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Country
82628
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Australia
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Phone
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+61 2 93825526
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Fax
82628
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Email
82628
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Insufficient funding
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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