Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000365662
Ethics application status
Approved
Date submitted
29/03/2023
Date registered
13/04/2023
Date last updated
13/04/2023
Date data sharing statement initially provided
13/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing health literacy needs in COVID-19 risk communication
Scientific title
Examining the impact of a novel COVID-19 risk communication tool on knowledge about COVID-19 vaccines in Australian adults
Secondary ID [1] 309339 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 329538 0
Condition category
Condition code
Public Health 326472 326472 0 0
Health promotion/education
Infection 326473 326473 0 0
Other infectious diseases
Respiratory 326474 326474 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The digital Covid Risk Calculator (CoRiCal) tool has been developed by a team of Australian GPs and epidemiologists in collaboration with the Immunisation Coalition to facilitate informed choice about COVID-19 vaccination risk and benefits: https://corical.immunisationcoalition.org.au.

INTERVENTIONS:
Participants will be randomised to 1 of 4 conditions via the Qualtrics Randomiser feature.

The three interventions include:



1.Standard CoRiCal output: Output directly from the CoRiCal calculator on the risks and benefits of the Pfizer vaccine. For the purposes of this study, the information is relevant for a 38 year old female who has received 3 COVID-19 vaccine doses (based on average population data).



The output includes 4 graphs and explanatory text answering the following questions:

1) What is my chance of getting COVID-19?

2) If I get COVID-19, what are my chances of dying?

3) What is my chance of having inflammation of my heart muscle (myocarditis)?

4) What is my chance of dying from inflammation of my heart muscle (myocarditis)?



The risks will be reported in absolute risk format. No changes will be made to the output.



2.Video of CoRiCal output in absolute risk format: The standard CoRiCal output information (in absolute risk format) will be explained in a video, delivered in a PowerPoint style with animations, icons and voice over explaining the information. The video will explain the 4 graphs in 2 minutes.



3.Video of CoRiCal output in 1 in x chance format: The standard CoRiCal output information (in 1 in x chance format) will be explained in a video, delivered in a PowerPoint style with animations, icons and voice over explaining the information. The video will explain the 4 graphs in 2 minutes.
Intervention code [1] 325774 0
Prevention
Intervention code [2] 325775 0
Behaviour
Comparator / control treatment
Control participants will be given standard written Australian government information on the Pfizer vaccine (https://www.health.gov.au/sites/default/files/documents/2022/08/covid-19-vaccination-information-on-comirnaty-pfizer-covid-19-vaccine.pdf). This will take approximately 2-5 minutes to read.
Control group
Active

Outcomes
Primary outcome [1] 334316 0
Understanding of messaging – measured using the average agreement score to the following 8 questions

1: The chance of catching COVID-19 is lower if you have a COVID-19 vaccine

2: The more doses of vaccine you get, the less likely you are to catch COVID-19

3: The chance of dying from COVID-19 is lower if you have a COVID-19 vaccine

4: The more doses of vaccine you get, the less likely you are to die from COVID-19

5: There is always a very small chance you can get inflammation of the heart muscle (myocarditis), unrelated to COVID-19

6: There is a very small increase in the chance of getting myocarditis after having a COVID-19 vaccine

7: There is a bigger increase in the chance of getting myocarditis after catching COVID-19

8: You are more likely to get myocarditis from catching COVID-19 than from a vaccine
Timepoint [1] 334316 0
Immediately post-intervention
Secondary outcome [1] 420233 0
Personal relevance adapted from Scherer et al (2013):

Show how much you agree with the following:

[7 point scale from Strongly disagree to Strongly agree]

a. I found the information was created personally for me

b. I felt that the information was relevant to me

c. I felt that the information was designed specifically for me
Timepoint [1] 420233 0
Immediately post-intervention
Secondary outcome [2] 420234 0
Negative/Positive emotional response from validated Berlin Emotional Responses to Risk Instrument (BERRI) scale by Petrova et al. (2022):

How do you feel about the information you just saw?

[7 point scale from Not at all to Extremely)

a. Assured

b. Hopeful

c. Relieved

d. Anxious

e. Afraid

f. Worried
Timepoint [2] 420234 0
Immediately post-intervention
Secondary outcome [3] 420235 0
Perceptions of the information/video from Davis et al. (2016):

Please show below how you felt about the information/video you just saw. The information/video was…

[5 point scale from Strongly disagree to Strongly agree]

a. worth remembering

b. attention-grabbing

c. powerful

d. informative

e. meaningful

f. convincing
Timepoint [3] 420235 0
Immediately post-intervention
Secondary outcome [4] 420236 0
Message credibility from Appleman and Sunder (2015):

How well do the following adjectives describe the content you just read/watched?

[7 point scale from Describes very poorly to Describes very well]

a. accurate

b. authentic

c. believable
Timepoint [4] 420236 0
Immediately post-intervention
Secondary outcome [5] 420237 0
Intention to get COVID-19 booster from McCaffery et al. (2020):

When the next booster is recommended, I intend to get it:

[7 point scale from Strongly disagree to Strongly agree]
Timepoint [5] 420237 0
Immediately post-intervention
Secondary outcome [6] 420238 0
Qualitative measure, a free response text question at the end of the Qualtrics form asking: Do you have any feedback on improving the COVID-19 vaccination information you saw?
Timepoint [6] 420238 0
Immediately post-intervention

Eligibility
Key inclusion criteria
Live in Australia, aged 18 or above
Minimum age
18 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)
Participants will be recruited from the general Australian public using a market research company, Dynata, which has an extensive participant database. Participants will be able to read the PIS and Consent Form before accessing the survey questions.
The survey itself will be hosted on the Qualtrics platform, which allows randomisation of participants such that participants are evenly randomised to each given condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Qualtrics platform includes a “Randomizer” tool to evenly allocate participants to each condition. Participants will be randomised once, to the control, the standard CoRiCal output, the absolute risk video and the 1 in x chance video.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analyses

Regression models will be used to answer research question, controlling for covariates. A priori sample size calculations determined that 500 participants per randomised group would yield >90% power to detect a small effect size in the primary outcomes of knowledge and intention to take the next recommended COVID-19 vaccine, assuming a two-sided alpha of 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/04/2023
Actual
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
1/06/2023
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313539 0
Commercial sector/Industry
Name [1] 313539 0
GSK Award via the Public Health Association of Australia
Country [1] 313539 0
Australia
Primary sponsor type
University
Name
Sydney Health Literacy Lab at the University of Sydney
Address
Room 128C Edward Ford Building A27, The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 315316 0
None
Name [1] 315316 0
Address [1] 315316 0
Country [1] 315316 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312722 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 312722 0
Ethics committee country [1] 312722 0
Australia
Date submitted for ethics approval [1] 312722 0
Approval date [1] 312722 0
02/02/2023
Ethics approval number [1] 312722 0
2022/90

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125670 0
Dr Carissa Bonner
Address 125670 0
Rm 226A, Edward Ford Building A27, The University of Sydney, NSW , 2006
Country 125670 0
Australia
Phone 125670 0
+61 2 9351 7125
Fax 125670 0
Email 125670 0
[email protected]
Contact person for public queries
Name 125671 0
Carissa Bonner
Address 125671 0
Rm 226A, Edward Ford Building A27, The University of Sydney, NSW , 2006
Country 125671 0
Australia
Phone 125671 0
+61 2 9351 7125
Fax 125671 0
Email 125671 0
[email protected]
Contact person for scientific queries
Name 125672 0
Carissa Bonner
Address 125672 0
Rm 226A, Edward Ford Building A27, The University of Sydney, NSW , 2006
Country 125672 0
Australia
Phone 125672 0
+61 2 9351 7125
Fax 125672 0
Email 125672 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
Participant confidentiality pertaining to recruitment via market research panels.


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.