Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001510235
Ethics application status
Approved
Date submitted
31/08/2018
Date registered
7/09/2018
Date last updated
24/03/2021
Date data sharing statement initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Short Message Service (SMS)- Reminders on Vaccine Hesitancy in Parents of Newborns
Scientific title
The Effect of Short Message Service (SMS)- Reminders on Vaccine Hesitancy in Parents of Newborns
Secondary ID [1] 295936 0
Nil known
Universal Trial Number (UTN)
U1111-1219-7737
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood preventable infections 309441 0
Condition category
Condition code
Infection 308284 308284 0 0
Other infectious diseases
Public Health 308368 308368 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: SMS-Reminder to New Parents
Method: Delivered via phone through mass SMS services.
Timing: 6 weeks post-natally, prior to their child's 6-8 week vaccination. Interventional SMS only sent once.
1) Group A (intervention): Telethon Kids health message: Your child is now due for their 2 month vaccination. Delaying a child’s vaccination can put them and other children at risk. Do not reply to this text message
2) Group B (control): Telethon Kids health message: Sleeping your baby on its back is safest for preventing SIDS (Sudden Infant Death Syndrome). Do not reply to this text message
Intervention code [1] 312260 0
Prevention
Intervention code [2] 312261 0
Behaviour
Comparator / control treatment
The control group receives the SMS at the same time as the treatment group however, the contents differ. The SMS sent to this group is around prevention of SIDS, not vaccinations.
Control group
Active

Outcomes
Primary outcome [1] 307255 0
Change in Vaccine Hesitancy Category as measured by PACV Short Scale
- Low Hesitancy (score 0-4)
- Medium Hesitancy(score 5-6)
- High Hesitancy (score 7-10)
Timepoint [1] 307255 0
Hesitancy questionnaire administered 4 weeks before intervention and 6 weeks after intervention.
Change in score on the questionnaire (and hence category) evaluated.
Secondary outcome [1] 351292 0
Nil.
Timepoint [1] 351292 0
Nil.

Eligibility
Key inclusion criteria
1. Parent(s) are above the age of 18
2. Parent(s) are English speaking (primary or secondary)
3. Mother is greater than or equal to 28 weeks pregnant
4. Parent(s) have a mobile phone with text messaging and data/wifi connection capabilities
5. Parent(s) are able to be contacted via mobile phone during the course of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Parent(s) who are unsuitable for the study as advised by clinic staff
2. Parent(s) suffer from a condition that interferes with their ability to give informed consent and/or comply with the study
3. Parent(s) with a baby born greater than or equal to 38 weeks.

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 randomisation through computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation process created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: A sample size of 274 participants (137 per invention arm) is required to detect at least a 30% reduction in the proportion of participants categorised as low vaccine hesitancy (score 0-4 out of 10) on the PACV short scale. This is based on: (i) expected proportions of low, medium and high vaccine hesitancy in the control arm of 72%, 13% and 15%, respectively11; (ii) 30% change from low to medium vaccine hesitancy category for the SMS intervention arm (thus the proportions for the low, medium and high categories would be 50%, 35% and 15%, respectively); (iii) significance level (a) of 5%; (iv) power of 80%; (v) equal allocation to intervention arms; and (v) sample size formula for the Wilcoxon-Mann-Whitney test by Zhao et al

Statistical Methods:
Demographic and other baseline characteristics will be summarised by assigned intervention arm (intent-to-treat). Categorical variables will be summarised by frequencies and percentages. Continuous variables with symmetric distributions will be summarised by intervention arm using mean and standard deviation, whereas continuous variables with asymmetric distributions will be summarised using median and interquartile range (25% and 75% percentiles).

PACV short scale category (ie. low, medium, high vaccine hesitancy) at the 12 week post-natal timepoint (primary outcome) will be compared between the negative-message SMS and control SMS arms using the Wilcoxon-Mann-Whitney test. The use of low, medium and high vaccine hesitancy categories will aid interpretation of the results, however, the individual scores for the PACV short scale will also be analysed using the Wilcoxon-Mann-Whitney test. Results from both analyses will be presented with approximate 95% confidence intervals and associated p-values.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
As specified early, due to time limitations
Date of first participant enrolment
Anticipated
14/09/2018
Actual
27/05/2019
Date of last participant enrolment
Anticipated
Actual
30/01/2020
Date of last data collection
Anticipated
Actual
30/06/2020
Sample size
Target
274
Accrual to date
Final
185
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11747 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 23831 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 300534 0
Other Collaborative groups
Name [1] 300534 0
Telethon Kids Institute
Country [1] 300534 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
Northern Entrance, Perth Children's Hospital,
15 Hospital Ave, Nedlands Western Australia 6009
Country
Australia
Secondary sponsor category [1] 300018 0
None
Name [1] 300018 0
Address [1] 300018 0
Country [1] 300018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301327 0
Women and Newborn Health Service Ethics Committee,
Ethics committee address [1] 301327 0
Ethics committee country [1] 301327 0
Australia
Date submitted for ethics approval [1] 301327 0
01/05/2018
Approval date [1] 301327 0
16/07/2018
Ethics approval number [1] 301327 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3050 3050 0 0
/AnzctrAttachments/375893-Ethics Approval!.pdf (Ethics approval)
Attachments [2] 3051 3051 0 0
/AnzctrAttachments/375893-The Effect of SMS Reminders on Vaccine Hesitancy_FINAL SUBMIT ONE.doc (Protocol)
Attachments [3] 3052 3052 0 0
/AnzctrAttachments/375893-17830_Participant Information Sheet_V01 (2).pdf (Participant information/consent)
Attachments [4] 3053 3053 0 0
/AnzctrAttachments/375893-17830_Consent_to_contact_V1.0.pdf (Participant information/consent)

Contacts
Principal investigator
Name 86630 0
A/Prof Thomas Snelling
Address 86630 0
Telethon Kids Institute
15 Hospital Ave, Nedlands WA 6009
Country 86630 0
Australia
Phone 86630 0
+61 8 6319 1817
Fax 86630 0
Email 86630 0
[email protected]
Contact person for public queries
Name 86631 0
Mudra Shah
Address 86631 0
Telethon Kids Institute
15 Hospital Ave, Nedlands WA 6009
Country 86631 0
Australia
Phone 86631 0
+61426863464
Fax 86631 0
Email 86631 0
[email protected]
Contact person for scientific queries
Name 86632 0
Mudra Shah
Address 86632 0
Telethon Kids Institute
15 Hospital Ave, Nedlands WA 6009
Country 86632 0
Australia
Phone 86632 0
+61426863464
Fax 86632 0
Email 86632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be disclosed to protect confidentiality. Individually identifiable or re-identifiable data will be stored on the Telethon Kids Institute centrally maintained computer network where access (including Virtual Private Network access) is securely controlled.


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.