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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

COVID-19

Long COVID

Condition category

Condition code

Public Health

Health promotion/education

Infection

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]

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]

Vaccine intention

Timepoint [1]

Immediately following intervention

Primary outcome [2]

Vaccine intention

Timepoint [2]

Immediately following intervention

Secondary outcome [1]

Vaccine attitudes

Timepoint [1]

Immediately following intervention

Secondary outcome [2]

Vaccine/long COVID knowledge

Timepoint [2]

Immediately after intervention

Secondary outcome [3]

Vaccine/long COVID knowledge

Timepoint [3]

Immediately after intervention

Secondary outcome [4]

Vaccine/long COVID knowledge

Timepoint [4]

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]

University

Name [1]

School of Psychology at University of Sydney

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

School of Psychology at University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

https://www.sydney.edu.au/research/research-integrity-and-ethics.html

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2024

Approval date [1]

24/07/2024

Ethics approval number [1]

2024/487

Summary

Brief summary

We wish to investigate whether vaccine intentions, attitudes, and knowledge are differentially influenced when presenting general versus specific long COVID and booster-related information. General information presents risk information in regard to long COVID as a whole, whereas the specific presentation shows information on specific long COVID symptom categories. We therefore aim to investigate whether there is a particular presentation of information that more effectively communicates long COVID and vaccine messages.

We also wish to see if there are any effects of adding a cognitive load task that some participants will have to allocate their attention to. We predict that participants viewing the general long COVID information will show higher vaccine intention, positive attitudes, and knowledge regarding boosters; we also predict that participants under cognitive load will have less vaccine intention and knowledge, as well as more negative attitudes, compared to participants under no load. Finally, we predict that the benefits of general information on intention, attitudes, and knowledge will be even more pronounced for those under cognitive load.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Carissa Bonner

Address

Edward Ford Building A27, University of Sydney, NSW, 2006

Country

Australia

Phone

+61 2 9351 7125

Fax

[email protected]

Contact person for public queries

Name

A/Prof Carissa Bonner

Address

Edward Ford Building A27, University of Sydney, NSW, 2006

Country

Australia

Phone

+61 2 9351 7125

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Carissa Bonner

Address

Edward Ford Building A27, University of Sydney, NSW, 2006

Country

Australia

Phone

+61 2 9351 7125

Fax

[email protected]

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: [email protected]).

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically