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Trial registered on ANZCTR
Registration number
ACTRN12618000789268
Ethics application status
Approved
Date submitted
19/04/2018
Date registered
10/05/2018
Date last updated
7/11/2022
Date data sharing statement initially provided
5/06/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
AUTOMATIC: Adaptive Trial of Messaging to Improve Immunisation Coverage
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Scientific title
Randomised multi-arm Bayesian adaptive trial of SMS reminders to improve the timeliness of routine vaccination in children
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Secondary ID [1]
290481
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None
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Universal Trial Number (UTN)
U1111-1189-6054
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Trial acronym
AUTOMATIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vaccination
300855
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Vaccine coverage
300858
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Immunisation
300859
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Condition category
Condition code
Infection
300679
300679
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
One of 12 active arms covering two domains: (i) SMS content (neutral, positive, negative or social norms) and (ii) timing (-14, 0 or +7 days relative to the vaccination due date);
Neutral messages consist of :“[CLINIC NAME]: [Child’s name] is due for a X-month vaccination on XX/XX/XX. To book or opt-out of SMS, call XXXX XXXX. Replies are not monitored, pls ignore SMS if you have an appt”
Positive messages consist of :“[CLINIC NAME]: [Child’s name] is due for a vaccination on XX/XX/XX. Vaccinating on time gives [Child’s name] the best defence against infectious diseases. To book or opt-out of SMS, call XXXX XXXX. Replies are not monitored, pls ignore SMS if you have an appt”
Negative messages consist of :“[CLINIC NAME]: [Child’s name] is due for a vaccination on XX/XX/XX. Delaying a child’s vaccination can put them and other children at risk. To book or opt-out of SMS, call XXXX XXXX. Replies are not monitored, pls ignore SMS if you have an appt”
Social norm messages consist of :“[CLINIC NAME]: [Child’s name] is due for a vaccination on XX/XX/XX. Vaccinating on time protects [Child’s name] and other children who are too young to be vaccinated. To book or opt-out of SMS, call XXXX XXXX. Replies are not monitored, pls ignore SMS if you have an appt”
Neutral SMS sent 14 days before the due-date
OR
Positive SMS sent 14 days before the due-date
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Negative SMS sent 14 days before the due-date
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Social Norms SMS sent 14 days before the due-date
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Neutral SMS sent on the due-date
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Positive SMS sent on the due-date
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Negative SMS sent on the due-date
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Social Norms SMS sent on the due-date
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Neutral SMS sent 7 days after the due-date
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Positive SMS sent 7 days after the due-date
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Negative SMS sent 7 days after the due-date
OR
Social Norms SMS sent 7 days after the due-date
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Intervention code [1]
296339
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Behaviour
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Comparator / control treatment
No SMS reminder (Control Group)
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Control group
Active
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Outcomes
Primary outcome [1]
300101
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Vaccination status (vaccinated or unvaccinated) at 28 days after scheduled vaccine due date for the index child for the index vaccine. On occasion, vaccination might occur prior to the due date. Such occasions will be counted as vaccinated by 28 days after the due date if it occurs no more than 14 days before the scheduled due date.
Parents may have multiple children eligible for study inclusion and each child may receive multiple vaccine doses during the trial period. The index child is the first child scheduled to be vaccinated after the parent’s randomisation date and the index vaccine is the first scheduled vaccine date for each child after the parent’s randomisation date.
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Assessment method [1]
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Timepoint [1]
300101
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Vaccination status at 28 days after the vaccine due date as measured by the difference between date of index vaccine administration and due date as recorded in the SmartVax system.
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Secondary outcome [1]
329046
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Time to vaccination (in days): difference in days relative to the scheduled due date from 14 days before to the date of administration of the index vaccine for the index child, censored at 42 days post vaccine due-date. Time to vaccination (in days): difference in days relative to the scheduled due date from 14 days before to the date of administration of the index vaccine for the index child, censored at 42 days post vaccine due-date.
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Assessment method [1]
329046
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Timepoint [1]
329046
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Any time between baseline (14 days prior to the scheduled vaccine date) and follow-up (28 days after the scheduled vaccine date). Events that occur prior to scheduled vaccine date will be coded as occurring on the scheduled vaccine date.
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Secondary outcome [2]
329047
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Time to vaccination from 14 days prior to vaccine due-date to the next vaccine administration date for every eligible scheduled vaccine for each child, censored at 42 days post vaccine due-date, grouped by child ID and nested in parent ID in the statistical analysis. Eligible scheduled child vaccines are those that occur after the parent’s randomisation date.
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Assessment method [2]
329047
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Timepoint [2]
329047
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Each child for any vaccine will contribute data from 14 days prior until 42 days after their individual scheduled vaccine date to this analysis.
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Secondary outcome [3]
329612
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Vaccination status (vaccinated or unvaccinated) at 28 days after the scheduled vaccine due date for all vaccines and all children.
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Assessment method [3]
329612
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Timepoint [3]
329612
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Each child for all vaccines will contribute data from 14 days prior until 28 days after their individual scheduled vaccine date to this analysis.
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Eligibility
Key inclusion criteria
Parents (18 years and older) of children aged 6 weeks – 4 years who are registered with a SmartVax registered GP clinic or community vaccination clinic
Parents must have a mobile phone number registered with the vaccine provider
The child must be due for an upcoming vaccine during the trial period
The child at the clinic previously, excluding 6 week old children their first vaccine dose
Eligible children must have their most recent details entered into their electronic medicalhealth record, including the parent mobile phone number and the child’s date of birth and name.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
The parent(s) of the child have previously requested not to be contacted by the clinic via SMS
Parents who in the opinion of clinic staff would be unsuitable for inclusion in the study, for example because they are known to attend for routine vaccinations elsewhere, they have relocated outside of the clinic catchment area, the registered mobile phone number is known to be obsolete or wrong, or because they are registered as conscientious objectors to vaccination
The critical information required to produce a unique identification number has not been entered properly into the practice’s electronic medical record (i.e. parent mobile phone number, child’s date of birth, child’s first and surname)
Children known or suspected to be Ttwins and triplets will be excluded; producing a unique identification number will not be possible for siblings with the same birthdate
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Study design
Purpose of the study
Educational / counselling / training
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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)
The people administering and receiving the intervention are blinded prior to the SMS being sent as the allocation and delivery systems are centalised and automated.
The people recording the data and maintaining the trial database are blinded to intervention allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Response adaptive computer based central randomisation
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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
Bayesian adaptive, randomised, multi-arm pragmatic trial
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
This is a Bayesian response-adaptive, randomised, multi-arm, pragmatic trial. The primary outcome is vaccination status (administered or not administered) by 28 days after the scheduled due date. Inferences in the trial will be based on a Bayesian logistic regression model for the primary outcome as a function of the interventions (type of message: neural, positive, negative, or social norms; and timing: -14, 0 or 7 days relative to scheduled due date), which will be used to calculate the posterior probability of superiority of each intervention arm conditional on the data observed. These posterior probabilities will be used to inform pre-specified decisions at scheduled interim analyses as the trial progresses. The first interim analysis occurs when the primary outcome has been observed on 1,500 participants, and subsequent interim analyses occur every additional 500 participants. For model parameters, weakly-informative prior distributions are specified. Model adjustment is made for the participants site, time of enrolment into the study, and the age at which the scheduled vaccination is to occur (2 months, 4 months, 6 months, 12 months, or 48 months).
The use of response-adaptive randomisation means that if an intervention allocation weighting is proportional to its probability of being the most effective intervention. Pre-specified decision rules are in place such that if at any interim analysis an intervention is declared inferior to control (no SMS message) that arm will be permanently dropped and if any single arm is declared more effective than control, then the control arm will be permanently dropped.
A secondary outcome is the time to vaccination in days for each participant relative to the scheduled due date. This outcome will be analysed using a discrete-time cumulative logistic model with similar adjustments and priors as the primary outcome model. The baseline log-hazard will be modelled flexibly using penalised O'Sullivan splines. Intervention effects are assumed to satisfy an assumption of proportional continuation ratios and are time-varying in that the intervention effect only applies from the time the SMS message was sent.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
31/08/2020
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Actual
14/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
10000
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Accrual to date
6583
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
294898
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Government body
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Name [1]
294898
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WA Department of Health
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Address [1]
294898
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189 Royal St
Perth WA 6000
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Country [1]
294898
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Australia
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Funding source category [2]
302968
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Other Collaborative groups
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Name [2]
302968
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RACP Foundation
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Address [2]
302968
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145 Macquarie St NSW 2000
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Country [2]
302968
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Australia
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Funding source category [3]
309964
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Charities/Societies/Foundations
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Name [3]
309964
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Ramaciotti Foundation
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Address [3]
309964
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GPO Box 4171, Sydney NSW 2001
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Country [3]
309964
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Telethon Kids Institute
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Address
100 Roberts Road Subiaco WA 6008
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Country
Australia
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Secondary sponsor category [1]
293736
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None
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Name [1]
293736
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Address [1]
293736
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Country [1]
293736
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296275
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University of Western Australia Human Research Ethics Committee
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Ethics committee address [1]
296275
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The University of Western Australia (M459) 35 Stirling Highway Crawley, Perth Western Australia 6009
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Ethics committee country [1]
296275
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Australia
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Date submitted for ethics approval [1]
296275
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23/11/2016
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Approval date [1]
296275
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30/05/2017
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Ethics approval number [1]
296275
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RA/4/1/8810
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Summary
Brief summary
We aim to conduct randomised multi-arm Bayesian adaptive trial of SMS reminders to determine whether personalised provider-initiated SMS reminders are effective for improving the timeliness of routine vaccination among Australian children. Parents will be enrolled across multiple SmartVax GP clinics and community-based providers in Western Australia.
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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
70242
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Dr Tom Snelling
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Address
70242
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Telethon Kids Institute
100 Roberts Rd
Subiaco WA 6008
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Country
70242
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Australia
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Phone
70242
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+61 401355389
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Fax
70242
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Email
70242
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tom.snelling@sydney.edu.au
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Contact person for public queries
Name
70243
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Tom Snelling
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Address
70243
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Telethon Kids Institute
100 Roberts Rd
Subiaco WA 6008
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Country
70243
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Australia
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Phone
70243
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+61 401355389
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Fax
70243
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Email
70243
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tom.snelling@sydney.edu.au
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Contact person for scientific queries
Name
70244
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Tom Snelling
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Address
70244
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Telethon Kids Institute
100 Roberts Rd
Subiaco WA 6008
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Country
70244
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Australia
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Phone
70244
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+61 401355389
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Fax
70244
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Email
70244
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tom.snelling@sydney.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Summary-level trial results will be shared and individual participant data can be requested subject to necessary HREC approvals. As a minimum, data sharing will include de-identified participant data including group allocation and time difference between scheduled vaccine date and vaccine administration date (in days).
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When will data be available (start and end dates)?
Summary-level results will be available 12 months after study completion, where study completion is 3 months after the last participant has been recruited or when the trial has stopped early for success or failure.
Individual data availability:
Start Date: 1 year after study completion
End Date: 5 years after study completion.
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Available to whom?
Researchers who provide a formal proposal and statistical analysis plan to the study team, including research hypotheses, how they will use data and how the results will be disseminated, will be considered, pending necessary ethics and governance approvals.
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Available for what types of analyses?
The data is suitable for efficacy analyses based on time to event data. No safety data is available.
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How or where can data be obtained?
A mechanism will be determined between the Chief Investigator, trial sponsor and the researchers requesting the data. This will include controlled access documented in a data use agreement between the researchers and the trial sponsor.
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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
Source
Title
Year of Publication
DOI
Embase
The AuTOMATIC trial: a study protocol for a multi-arm Bayesian adaptive randomised controlled trial of text messaging to improve childhood immunisation coverage.
2023
https://dx.doi.org/10.1186/s13063-023-07097-3
N.B. These documents automatically identified may not have been verified by the study sponsor.
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