Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001753246
Ethics application status
Approved
Date submitted
7/10/2018
Date registered
25/10/2018
Date last updated
25/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Vaxcards: A study on the effectiveness of a collectible card game on the education and uptake of vaccination
Scientific title
The effectiveness of a collectible card game on the education and uptake of vaccination with a pragmatic cluster randomised control trial.
Secondary ID [1] 295958 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vaccination education 309559 0
vaccine uptake 309560 0
Condition category
Condition code
Infection 308382 308382 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The school children will already be undertaking the vaccination program as part of their year 7 program at their school and consent will not be sort from them to participate in the scheduled vaccination program. De-identified, routinely collected information about returned consent forms will be provided to the investigators by Casey Council for the schools involved in the trial.

The experimental group will be provided a hand out with the consent form for vaccination that will serve the purpose of the explanatory statement and consent to receive the intervention (a pack of Vaxcards) or not in a tick box to be returned with the consent forms for their routine vaccination.

The pack of vaxcards contains 10 character cards that represent the disease vaccinated against in the immunization schedule and information about these diseases.

The intervention will be delivered once and are intended to be kept by participants and are provided with instructions on how to play the game but not provided indications of use, they may play with the cards as they wish. There are no strategies implemented to assess/monitor adherence to the intervention.

Schools participating in the vaccination program will email and mail parents and students with instructions for completing survey with explanatory statement and consent box hosted by Qualtrix
Intervention code [1] 312363 0
Other interventions
Comparator / control treatment
District council school vaccination program for year 7 students through consent of the participating schools. 23 Schools will be ranked in previous vaccination rate from council program and split into top 50 and bottom 50 percent, labelled high and low groups. These will be each cluster randomized to the control and experimental group for intervention.
The control group will participate in this routine vaccination program and will not be consented for the primary outcome measurement routinely collected by the council.
Control group will be explained the trial after vaccination and be offered the intervention if desired with a parental explanatory sheet after vaccination and after the primary outcome measurement has been recorded. They will be offered the option to receive the Vaxcards at the end of the vaccination program in August 2019.

Schools participating in the vaccination program will email and mail parents and students with instructions for completing survey with explanatory statement and consent box hosted by Qualtrix
Control group
Active

Outcomes
Primary outcome [1] 307359 0
Return rate of 'yes' consent form for vaccination of the groups
Timepoint [1] 307359 0
end of council vaccination program for 2019 to the participating schools
Secondary outcome [1] 351595 0
quantitative survey composite data of parental knowledge, attitudes and behaviors towards vaccination. Survey used will be the validated PACV tool https://www.ncbi.nlm.nih.gov/pubmed/27566902
Timepoint [1] 351595 0
after vaccination in community school vaccination program
Secondary outcome [2] 352963 0
quantitative survey composite data of student knowledge, attitudes and behaviors towards vaccination.
Survey used will be the modified PACV tool https://www.ncbi.nlm.nih.gov/pubmed/25659278
Timepoint [2] 352963 0
after vaccination in community school vaccination program

Eligibility
Key inclusion criteria
District of Casey council school vaccination program for year 7 students and parents of students.
Minimum age
11 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

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)
Allocation is concealed to the statistician through a central computer randomization code
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
25 schools will be block randomised to two groups (of 11 and 12). In 2018, there were 12 schools with less than 100 year 7 students and 11 schools with 100 or more. There were 8 schools with a card return less than 90%. To ensure balanced proportions of these school characteristics in the test and control groups, we will stratify the randomisation by: school number of year 7 students ('less than 100'/'100 or more') and card return (<90%/+90%).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study has ample power ( greater than 95%) to detect a change in proportion of 5%. Power calculation done using Stata statistical software stepped-wedge: for 23 clusters defined at the level of the school, the primary outcome measure is the return of the form (yes/no) from 120 students per school, significance level set at 0.05, intraclass correlation coefficient (ICC) within schools of 0.3, approximately half the schools receiving the intervention (ie steps equal to 1) , and data examined at two time points (baseline, year 1).

Quantitative surveys on likert scales will be analysed using chi-squared.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2018
Actual
Date of last participant enrolment
Anticipated
31/01/2019
Actual
Date of last data collection
Anticipated
1/08/2019
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300554 0
University
Name [1] 300554 0
Monash University
Country [1] 300554 0
Australia
Primary sponsor type
University
Name
Monash University department of general practice
Address
270 ferntree gully road
notting hill
vic
aus
3168
Country
Australia
Secondary sponsor category [1] 300125 0
None
Name [1] 300125 0
Address [1] 300125 0
Country [1] 300125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301348 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 301348 0
Ethics committee country [1] 301348 0
Australia
Date submitted for ethics approval [1] 301348 0
03/10/2018
Approval date [1] 301348 0
17/10/2018
Ethics approval number [1] 301348 0
16814

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3182 3182 0 0
/AnzctrAttachments/375909-Project 16814 - Certificate of Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 86694 0
Dr Daniel Epstein
Address 86694 0
building 1
department general practice, Monash University
270 ferntree gully road
notting hill
vic 3168
Country 86694 0
Australia
Phone 86694 0
+61 3 99024514
Fax 86694 0
Email 86694 0
[email protected]
Contact person for public queries
Name 86695 0
Daniel Epstein
Address 86695 0
building 1
department general practice, Monash University
270 ferntree gully road
notting hill
vic 3168
Country 86695 0
Australia
Phone 86695 0
+61 3 99024514
Fax 86695 0
Email 86695 0
[email protected]
Contact person for scientific queries
Name 86696 0
Daniel Epstein
Address 86696 0
building 1
department general practice, Monash University
270 ferntree gully road
notting hill
vic 3168
Country 86696 0
Australia
Phone 86696 0
+61 3 99024514
Fax 86696 0
Email 86696 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseRecruiting for research on sensitive topics in schools: an experience with Vaxcards, a collectable vaccine card game.2021https://dx.doi.org/10.1186/s13063-021-05288-4
N.B. These documents automatically identified may not have been verified by the study sponsor.