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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

vaccination education

vaccine uptake

Condition category

Condition code

Infection

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]

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]

Return rate of 'yes' consent form for vaccination of the groups

Timepoint [1]

end of council vaccination program for 2019 to the participating schools

Secondary outcome [1]

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]

after vaccination in community school vaccination program

Secondary outcome [2]

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]

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]

University

Name [1]

Monash University

Address [1]

Department of General Practice,
Ferntree Gully Rd
Notting hill 3168
Victoria

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash Research Office,  26 Sports Walk, Monash University, Wellington Road, Clayton VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/10/2018

Approval date [1]

17/10/2018

Ethics approval number [1]

16814

Summary

Brief summary

In this study we aim to test a tool that has been designed for incentivising and educating vaccination among the school age population. The primary outcome will measure return rates of consent forms of those incentivised to do so with the collection of the vaccine card game ‘Vaxcards’. Secondary outcome measures will assess the effectiveness for the tool to increase knowledge and move attitudes towards behaviour change among school age vaccine recipients and their parents.

We hypothesise that consent form return rates for community school vaccination will increase to those offered a pack of vaxcards. We also hypothesized that children and parents who receive a pack of vaxcards will show improved knowledge, attitudes and behaviors towards vaccination

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/375909-Project 16814 - Certificate of Approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Daniel Epstein

Address

building 1
department general practice, Monash University
270 ferntree gully road
notting hill
vic 3168

Country

Australia

Phone

+61 3 99024514

Fax

[email protected]

Contact person for public queries

Name

Daniel Epstein

Address

building 1
department general practice, Monash University
270 ferntree gully road
notting hill
vic 3168

Country

Australia

Phone

+61 3 99024514

Fax

[email protected]

Contact person for scientific queries

Name

Daniel Epstein

Address

building 1
department general practice, Monash University
270 ferntree gully road
notting hill
vic 3168

Country

Australia

Phone

+61 3 99024514

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Recruiting for research on sensitive topics in schools: an experience with Vaxcards, a collectable vaccine card game.	2021	https://dx.doi.org/10.1186/s13063-021-05288-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically