Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000698572
Ethics application status
Approved
Date submitted
10/05/2024
Date registered
3/06/2024
Date last updated
11/08/2024
Date data sharing statement initially provided
3/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of information presentation and cognitive load on views toward COVID-19 booster vaccines
Scientific title
Impact of information presentation and cognitive load on COVID-19 booster vaccine intentions, attitudes, and knowledge in Australian adults
Secondary ID [1] 312100 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID 333769 0
COVID-19 333876 0
Condition category
Condition code
Public Health 330444 330444 0 0
Health promotion/education
Infection 330550 330550 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the effects of presenting long COVID and booster-related information on vaccine intentions, knowledge, and attitudes, when the information is presented in terms of either general or specific outcomes. General information will show the likelihood of developing at least one long COVID symptom (with vs. without boosters), while specific information will additionally show likelihoods for 5 specific long COVID symptomatic categories (cardiovascular, gastrointestinal, pulmonary, metabolic, neurological).
Additionally, some participants will be allocated to a cognitive load condition, wherein they will be asked to memorise and later recall a 7-digit number. The purpose of this is to investigate whether an interaction exists between presentation type and cognitive load.

Participants (from the student population) will be able to access the survey link via the Usyd SONApsych website, once they have signed up to participate in the study.

Upon starting the survey, participants will be randomised to 1 of 4 conditions via the Qualtrics Randomiser feature. The four conditions are:

1. General-with-load (general long COVID information and additional cognitive load)
2. General-no-load (general information and no additional cognitive load)
3. Specific-with-load (specific long COVID information and additional cognitive load)
4. Specific-no-load (specific long COVID information and no additional cognitive load)

Each information package is anticipated to take 1-2 minutes to read. Participants who are asked to recall the 7-digit number will be asked to do so right after they have viewed the long COVID information (i.e. they will have to retain the 7-digit number for the duration that they are viewing the long COVID information).

To monitor attention to the survey, we will include an attention check in the outcome questions. The question will ask participants to select a certain response.
Intervention code [1] 328562 0
Behaviour
Comparator / control treatment
General-no-load will be the comparator (general information with no cognitive load task)
Control group
Active

Outcomes
Primary outcome [1] 338204 0
Vaccine intention
Assessment method [1] 338204 0
Participants will answer a question assessing their intentions to receive booster vaccines, after viewing the long Covid information. The question is as follows: I intend to get the next booster when it is recommended for me: [7 point scale from Very Likely (1) to Very Unlikely (7)]
Timepoint [1] 338204 0
Immediately following intervention
Primary outcome [2] 338311 0
Vaccine intention
Assessment method [2] 338311 0
Participants will be asked to respond to the following question assessing vaccine intention, which consists of 6 statements. Responses to each statement will be assessed together, i.e. to generate a composite score of vaccine intention. Please answer the following questions about the booster vaccination: a) I am willing to do anything to get vaccinated against COVID-19 b) I am determined to get a vaccination against COVID-19 c) I would do my best to avoid the vaccine d) I have seriously thought about receiving the COVID-19 vaccine e) I think the COVID-19 vaccine is not safe f) I would prefer to stay at home, rather than get vaccinated against COVID-19 [7 point scale, from Total disagreement to Total Agreement]
Timepoint [2] 338311 0
Immediately following intervention
Secondary outcome [1] 434959 0
Vaccine attitudes
Assessment method [1] 434959 0
Semantic differentials question in questionnaire assessing attitudes toward booster vaccines: 1. To receive a booster vaccination against COVID-19 is: [7 point scale for each semantic differential] a. Bad-good b. Stupid-wise c. Dangerous-safe d. Useless-effective e. Unpleasant-pleasant f. Irresponsible-responsible g. Disturbing-reassuring
Timepoint [1] 434959 0
Immediately following intervention
Secondary outcome [2] 434960 0
Vaccine/long COVID knowledge
Assessment method [2] 434960 0
Participants will be asked the following multiple choice knowledge questions in the questionnaire: 1. Recall the output you were shown earlier. What is the approximate risk of having at least one long COVID symptom (after contracting COVID) if you have received two boosters? a. 1 in 2 b. 1 in 5 c. 1 in 3 d. 1 in 10 2. What is the approximate risk of having at least one long COVID symptom (after contracting COVID) if you received no boosters? a. 1 in 2 b. 1 in 5 c. 1 in 3 d. 1 in 10 Note: For all vaccine/long COVID knowledge questions, we also aim to look at the composite of responses to these questions. However, we will also conduct independent analyses of responses to the questions as further analysis, and have thus put these in separate response boxes for convenience.
Timepoint [2] 434960 0
Immediately after intervention
Secondary outcome [3] 435569 0
Vaccine/long COVID knowledge
Assessment method [3] 435569 0
Question Receiving COVID booster vaccination: a. Reduces the likelihood of experiencing long COVID symptoms b. Increases the likelihood of experiencing long COVID symptoms c. Has no effect on the likelihood of experiencing long COVID symptoms
Timepoint [3] 435569 0
Immediately after intervention
Secondary outcome [4] 435570 0
Vaccine/long COVID knowledge
Assessment method [4] 435570 0
Question Which of the following were mentioned as long COVID symptom categories (select all that apply)? a. Gastrointestinal b. Neurological c. Skeletal d. Pulmonary e. Psychological f. Cardiovascular g. Metabolic h. Dermatological i. Muscular
Timepoint [4] 435570 0
Immediately after intervention

Eligibility
Key inclusion criteria
Live in Australia, aged 18 or above, able to read and write English
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
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Qualtrics platform includes a “Randomiser” that evenly and randomly allocates participants to each condition. Participants will be randomly allocated to one of the four conditions through this randomiser function.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with Qualtrics Randomiser software
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/07/2024
Actual
29/07/2024
Date of last participant enrolment
Anticipated
15/09/2024
Actual
Date of last data collection
Anticipated
15/09/2024
Actual
Sample size
Target
171
Accrual to date
160
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316458 0
University
Name [1] 316458 0
School of Psychology at University of Sydney
Country [1] 316458 0
Australia
Primary sponsor type
University
Name
School of Psychology at University of Sydney
Country
Australia
Secondary sponsor category [1] 318632 0
None
Name [1] 318632 0
Country [1] 318632 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315248 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 315248 0
Ethics committee country [1] 315248 0
Australia
Date submitted for ethics approval [1] 315248 0
08/04/2024
Approval date [1] 315248 0
24/07/2024
Ethics approval number [1] 315248 0
2024/487

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 134126 0
A/Prof Carissa Bonner
Address 134126 0
Edward Ford Building A27, University of Sydney, NSW, 2006
Country 134126 0
Australia
Phone 134126 0
+61 2 9351 7125
Email 134126 0
carissa.bonner@sydney.edu.au
Contact person for public queries
Name 134127 0
A/Prof Carissa Bonner
Address 134127 0
Edward Ford Building A27, University of Sydney, NSW, 2006
Country 134127 0
Australia
Phone 134127 0
+61 2 9351 7125
Email 134127 0
carissa.bonner@sydney.edu.au
Contact person for scientific queries
Name 134128 0
A/Prof Carissa Bonner
Address 134128 0
Edward Ford Building A27, University of Sydney, NSW, 2006
Country 134128 0
Australia
Phone 134128 0
+61 2 9351 7125
Email 134128 0
carissa.bonner@sydney.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data will be made available to the Usyd data repository, which is publicly available.

Conditions for requesting access:
• -

What individual participant data might be shared?
• The anonymous (de-identified) data from individual participants' responses will be shared. Participants will in no way be identifiable from this data.

What types of analyses could be done with individual participant data?
• Data will be available for future studies that wish to use it in similar investigations and/or meta analyses.

When can requests for individual participant data be made (start and end dates)?
From:
Data will be made available immediately following publication.
No end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data can be obtained via the Usyd repository, which is publicly available.
A/Prof Carissa Bonner may be contacted for further details (email: carissa.bonner@sydney.edu.au).

Are there extra considerations when requesting access to individual participant data?
No


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.