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Trial registered on ANZCTR
Registration number
ACTRN12620000804987
Ethics application status
Approved
Date submitted
1/06/2020
Date registered
10/08/2020
Date last updated
10/08/2020
Date data sharing statement initially provided
10/08/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Vaxcards: A statewide trial on the effectiveness of a collectible card game on the education and uptake of vaccination
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Scientific title
A Statewide trial on the effectiveness of a collectible card game on the education and uptake of vaccination with a pragmatic cluster randomised control trial.
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Secondary ID [1]
301419
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
This record is a follow-up study of ACTRN12618001753246
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Health condition
Health condition(s) or problem(s) studied:
vaccination education
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vaccine uptake
317965
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Condition category
Condition code
Infection
315779
315779
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0
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Other infectious diseases
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Public Health
316000
316000
0
0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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 for vaccination is done separately by the Department of Health and Human Services. For this study, we will offer parents the chance to return the vaxcards game intervention if they do not wish for their children to participate. 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.
All students in the normal vaccination program are provided the consent form for community vaccination by the council for content to vaccinate. The experimental group will also be provided a 1 page handout about receiving a game of vaxcards when their consent form is returned. In term 1 the students who return their consent form will be provided a pack of the vaccination card game Vaxcards. The return rate of consent forms will form the primary outcome measure.
There will be slight variations in the timing of the intervention among sub groups in the experimental group.
1. receiving the starter pack of vaxcards at the time of the council consent form, school posters, teachers provided lesson plans, HPV card at time of vaccination.
-starter pack contains: instructions on how to play the game, names and characters of 11 diseases (hepatitis B, measles, meningococcal, pneumococcal, rotavirus, rubella, mumps, varicella, dipthteria, pertussis, tetanus and HPV). Cards contain information on the disease symptoms, vector, method of infection eg droplet/blood, incidence. worldwide mortality.
2. receiving the starter pack of vaxcards at the time of the council consent form, school posters, teachers provided lesson plans, HPV card at time of vaccination, class sets of full packs.
-full pack contains all disease character cards (influenza, measles, meningococcal, mumps, pertussis, rubella, tetanus, hpv, dengue, HIV, hookworm, leishmaniasis, malaria, schistosomiasis, dipthteria, hepatitis B, chagas, smallpox, polio, cooler, typhoid, hepatitis A, Japanese encephalitis, tuberculosis, rabies, yellow fever, rotavirus, varicella.)
3. receiving the random pack of vaxcards at the time of the council consent form, school posters, teachers provided lesson plans, class sets of full packs.
-random packs will contain 7 random characters above + always contain year 7 vaccine specific cards HPV, dipthteria, tetanus, pertussis.
4. receiving the full pack of vaxcards at the time of the council consent handout, school posters, teachers provided lesson plans.
For the teacher-provided lesson plans:
- modules/topics covered during the intervention lessons include: herd immunity, why are people vaccine hesitant, risk and benefit of vaccines, story of smallpox eradication, how vaccines work, differences between pathogens, how disease spreads, how vaccines are made.
- the frequency and duration of intervention lessons will be decided by the teacher but modules are provided include 3-4 x 50minute lessons
- teachers providing these lessons will be provided videos and material links for reading/upskilling prior to class delivery.
After Vaccination programs are complete, both experimental and control group students and parents will be asked to complete the attached knowledge, attitudes and behaviours survey delivered through an email link or by mail by the school to the Qualtrics platform where they will be provided information and consent to the survey. This will form the secondary outcome measurement.
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 parents and students with instructions for completing survey with explanatory statement and consent box hosted by Qualtrix
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Intervention code [1]
317731
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Other interventions
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Comparator / control treatment
The control group will participate in the routine vaccination program and will not be consented for the primary outcome measurement of vaccination, as this will be routinely collected by the council and consent for this is separately done by the Department of health and human services. We will, however, measure their consent return rate. The reason to not consent them is so they do not have a change to their consent rates with an observer effect. This has been presented to the ethics committee and accepted as they would usually go through the consent form return process as part of normal council vaccinations and the consent process to the vaccination is separate to converting for the trial. Their vaccinaiton card return rates will simply be recorded for comparison to the intervention groups as a baseline measure.
Control Schools participating in the trial will email parents and students with instructions for completing survey with an explanatory statement and consent box hosted by Qualtrix 2 weeks after vaccination.
Control schools will be offered a printable copy of the intervention for group 1, the starter set box 1 month after surveys have been collected and informed of the study.
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Control group
Active
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Outcomes
Primary outcome [1]
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Return rate of 'yes' consent form for vaccination of the groups, routinely collected by the councils for both the intervention and control groups.
This data will be collected from the councils by data sharing summary totals at the school level, as they are routinely recorded and provided to the health department.
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Assessment method [1]
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Timepoint [1]
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timepoint 0 will be the vaccination program data from 2019 for each school.
(2020 vaccination data will not be used as timepoint 0 baseline due to the interruption of schools programs from COVID19)
end of council vaccination program for 2021 to the participating schools will form timepoint 1.
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Secondary outcome [1]
383490
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quantitative survey composite data of parental knowledge, attitudes and behaviors towards vaccination. Survey used will be the validated Vaccine Confidence Index(tm)
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Assessment method [1]
383490
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Timepoint [1]
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2 weeks after vaccination in the council school vaccination program for 2021
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Eligibility
Key inclusion criteria
State of Victoria school vaccination program for year 7 students and parents of students.
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Minimum age
11
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
none
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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)
Allocation is concealed to the statistician through a central computer randomization code
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sample
Clusters randomly selected.
Each school is a cluster.
- Aiming for 75% metro 25% rural/regional representation
we aim for:
18/24 treatment clusters in metro
54/72 control clusters in metro
6/24 treatment clusters in non-metro
18/72 control clusters in non-metro
Randomization stratification
Each ‘treatment cluster/school’ will be randomly matched with three ‘control cluster/school’.
Matching stratification variables are:
- LGA
- Size (less than 100pupils; 100+)
- Vaccine_baseline (low/high determined by above or below 80%)
If necessary, if an LGA doesn’t have 4 comparable schools, then we will match using these
stratification variables:
- Size (less than100pupils; 100+)
- Vaccine_baseline (low/high determined by above or below 80%)
- Metro/non-metro
- Indexed relative social disadvantage (IRSD) quintile or quartile
Randomization logic
Schools are drawn from the state of Victoria without replacement. This means that once a school
has been randomly selected, it cannot be selected again.
First at the Local Government Area (council) level
1. Randomly select a LGA area in Victoria:
o If LGA has 4 comparable schools, then go to Box 1.
2. Repeat step 1, ensuring new cluster names are created.
3. Stop when one of the two options come first:
4. Stop when we have 75% metro schools. Then target non-metro areas.
or
5. Stop when we have 25% metro schools. Then target metro areas.
Box 1:
Randomly start at a, b, c, or d:
randomly select one school (create new cluster name eg “clusterTa1”),
allocate as treatment “intervention a”.
randomly select three control schools (create new cluster names eg
clusterC1, clusterC2, clusterC3) with same Size (less than 100pupils; 100+) and
Vaccine_baseline (low/high)
repeat step (a) immediately but allocate as treatment “intervention b”
randomly select three control schools with same Size and Vaccine_baseline
repeat step (a) but allocate as treatment “intervention c”
randomly select three control schools with same Size and Vaccine_baseline
repeat step (a) but allocate as treatment “intervention d”
randomly select three control schools with same Size and Vaccine_baseline
complete a-d above before going to step 2 above.
To allocate schools to one of four treatment groups, randomisation by minimiation was done to ensure a balance of these variables in each of the 4 Tx groups:
- school Size (less than 100pupils; 100+)
- Vaccine_baseline (low/high determined by above or below 80%)
- Metro/non-metro
- single sex
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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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
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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2021
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Actual
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Date of last participant enrolment
Anticipated
31/01/2021
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Actual
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Date of last data collection
Anticipated
1/12/2021
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Actual
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Sample size
Target
11700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
305858
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Government body
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Name [1]
305858
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Department of Premier and Cabinet
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Address [1]
305858
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1 Treasury Place, Melbourne, VIC 3002
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Country [1]
305858
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Australia
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Funding source category [2]
306020
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University
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Name [2]
306020
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Monash University
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Address [2]
306020
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Department of General Practice, Ferntree gully road, Notting Hill Victoria 3168
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Country [2]
306020
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Australia
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Funding source category [3]
306021
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Commercial sector/Industry
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Name [3]
306021
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Public Health Association Australia and GSK
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Address [3]
306021
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20 Napier Cl, Deakin ACT 2600
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Country [3]
306021
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
Department of General Practice,
Ferntree Gully Rd
Notting hill 3168
Victoria
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Country
Australia
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Secondary sponsor category [1]
306306
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Government body
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Name [1]
306306
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Department of Premier and Cabinet
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Address [1]
306306
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Behavioural Insights Team
1 Treasury Place, Melbourne
Vic 3000
Aus
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Country [1]
306306
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Australia
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Other collaborator category [1]
281340
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Government body
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Name [1]
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Department of Health and Human Services
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Address [1]
281340
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50 Lonsdale St, Melbourne VIC 3000
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Country [1]
281340
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306118
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Monash University Human Research Ethics Committee (MUHREC)
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Ethics committee address [1]
306118
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26 Sports Walk, Clayton VIC 3168
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Ethics committee country [1]
306118
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Australia
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Date submitted for ethics approval [1]
306118
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31/07/2019
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Approval date [1]
306118
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31/10/2019
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Ethics approval number [1]
306118
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22340
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Summary
Brief summary
In this statewide 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 the proportion of vaccination rates 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.
We will be testing several arms of the intervention to see the most effective means of delivery and timing of the intervention.
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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 Daniel S Epstein
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Address
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Department of General Practice
1/270 Ferntree Gully Rd, Notting Hill VIC 3168
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Country
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Australia
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Phone
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+61 3 99024514
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Fax
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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 Daniel S Epstein
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Address
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Department of General Practice
1/270 Ferntree Gully Rd, Notting Hill VIC 3168
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Country
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Australia
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Phone
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+61 3 99024514
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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 Daniel S Epstein
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Address
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Department of General Practice
1/270 Ferntree Gully Rd, Notting Hill VIC 3168
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Country
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Australia
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Phone
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+61 3 99024514
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Fax
102776
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Email
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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
Data will not be collected at an individual level, but at school level.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
8129
Ethical approval
379929-(Uploaded-01-06-2020-14-39-55)-Study-related document.pdf
8130
Informed consent form
379929-(Uploaded-22-06-2020-10-15-33)-Study-related document.pdf
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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