Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001229662
Ethics application status
Approved
Date submitted
1/11/2023
Date registered
29/11/2023
Date last updated
1/08/2024
Date data sharing statement initially provided
29/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of a Short Video Intervention on Critically Appraising Online Health Information
Scientific title
The Effects of a Short Video Intervention on Young Australian (aged 18-39) Online Health Literacy Skills
Secondary ID [1] 310861 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Online health literacy 331903 0
e-health literacy 332052 0
Condition category
Condition code
Public Health 328634 328634 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will test the following research questions:
Can we improve health literacy skills and knowledge using an intervention informed by psychology and communication theory to improve critical appraisal of online information?
Is the delivery method of information going to affect knowledge outcomes? If so, which delivery method is most effective?

This study is a survey which will be conducted online through the Qualtrics platform. We will recruit an online sample stratified by high and low education via Qualtrics.

Eligible panel members will be invited to participate. This will include any adults aged 18-39, with quota sampling based on gender and education groups. Participants will read the participant information sheet and click a button to indicate consent to participate. They will complete a 10-minute online survey including baseline measures, viewing one of the three health literacy interventions or no intervention (control), and completing outcome measures.

This will be a four-arm randomised-control trial among Australian adults 18-39 years.
The participants will be randomly allocated to receive the health literacy information via either one of the three interventions: 1) written text information, 2) animated videos, 3) TikTok-style videos, or they will be assigned to the control group.

1) Written text condition:
The text condition for critically appraising online health information was based on various critical appraisal tools including the "Trust it or Trash it?" method (“Trust it or trash it?” http://www.trustortrash.org/). The text focuses on a tool called WHO-WHEN-WHY which was developed by the researchers. This is a critical appraisal tool that can be used as a practical guide to assess the quality of online health information.
To address the general education levels of the sample, relevant written information was run through the SHeLL editor (https://shell.techlab.works/ ), a tool that identifies issues like complex language and long sentences and suggests alternatives to improve understandability.
Participants will be required to spend at least 3 minutes reading the information.

2) Animation
Two animated videos for the interventions are based on the WHO-WHEN-WHY model above. These videos are both 2 minutes long. These videos were commissioned online using the services of a professional animation film making freelancer. All members of the research team were involved in the production of these videos, including providing feedback to the animator and refining the script to suit the format of the video.

3) Tiktok conditions:
The videos for the interventions are based on the WHO-WHEN-WHY model above. Two videos were created by a health communicator to model the Tiktok format of videos. These videos are both 2 minutes long.
Intervention code [1] 327284 0
Behaviour
Intervention code [2] 327396 0
Treatment: Other
Comparator / control treatment
Control participants will be given written Australian dietary guidelines, including visual information regarding the Australian Guide to Healthy Eating.
Control group
Active

Outcomes
Primary outcome [1] 336443 0
Online Health Literacy
Timepoint [1] 336443 0
Immediately post-intervention
Secondary outcome [1] 428425 0
Click-through-rate (frequency of clicking on a website link to access further information about the topic)
Timepoint [1] 428425 0
Immediately post-intervention
Secondary outcome [2] 428426 0
eHealth Literacy skill
Timepoint [2] 428426 0
Pre- and post-intervention immediately
Secondary outcome [3] 428427 0
Perceptions of the information/video
Timepoint [3] 428427 0
immediately post-intervention
Secondary outcome [4] 428428 0
Personal relevance
Timepoint [4] 428428 0
immediately post-intervention
Secondary outcome [5] 428429 0
Intention to share on socials
Timepoint [5] 428429 0
immediately post-intervention
Secondary outcome [6] 428430 0
Helpfulness of the WHO-WHY-WHEN guide, purpose-built item
Timepoint [6] 428430 0
Immediately post-intervention
Secondary outcome [7] 428431 0
Novelty of information (a three-item purpose-built measure)
Timepoint [7] 428431 0
Immediately post-intervention
Secondary outcome [8] 438210 0
Heat-map questions to assess critical skills for identifying trustworthy information on websites
Timepoint [8] 438210 0
Secondary outcome [9] 438211 0
Heat-map questions to assess critical skills for identifying trustworthy information on websites
Timepoint [9] 438211 0
Immediately post-intervention only

Eligibility
Key inclusion criteria
Live in Australia, aged 18-39
Minimum age
18 Years
Maximum age
39 Years
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)
Participants will be recruited from the general Australian public using a market research company, Qualtrics, 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 using the inbuilt automated algorithm of the platform. Thus, the allocation is concealed through the platform's inbuilt randomisation tool.
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 written text, Animation, or TikTok condition.
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
Statistical analysis will be conducted using planned contrasts between the three intervention arms and control arm, implemented in regression models. The influence of age, gender, language, education, health literacy, self-assessed health status, and the presence of pre-existing or chronic health conditions, will be examined by including appropriate interaction terms within the regression models. The total sample size required is N=2120. This is based on the primary outcome of critical appraisal skill level and an expected small effect size of 0.1. The number of participants required per arm (4 arms), to provide 90% power at error type I (alpha =0.05) is 530 (this is a balanced design).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/06/2024
Actual
8/07/2024
Date of last participant enrolment
Anticipated
7/08/2024
Actual
Date of last data collection
Anticipated
7/08/2024
Actual
Sample size
Target
2120
Accrual to date
1839
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315117 0
Government body
Name [1] 315117 0
National Health and Medical Research Council, NHMRC
Country [1] 315117 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] 317135 0
None
Name [1] 317135 0
Address [1] 317135 0
Country [1] 317135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314055 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 314055 0
Ethics committee country [1] 314055 0
Australia
Date submitted for ethics approval [1] 314055 0
06/04/2023
Approval date [1] 314055 0
22/05/2023
Ethics approval number [1] 314055 0
2023/275

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

Contacts
Principal investigator
Name 130258 0
Prof Kirsten McCaffery
Address 130258 0
Room 128B Edward Ford Building A27, The University of Sydney, NSW 2006
Country 130258 0
Australia
Phone 130258 0
+61 2 9351 7220
Fax 130258 0
Email 130258 0
[email protected]
Contact person for public queries
Name 130259 0
Kirsten McCaffery
Address 130259 0
Room 128B Edward Ford Building A27, The University of Sydney, NSW 2006
Country 130259 0
Australia
Phone 130259 0
+61 2 9351 7220
Fax 130259 0
Email 130259 0
[email protected]
Contact person for scientific queries
Name 130260 0
Kirsten McCaffery
Address 130260 0
Room 128B Edward Ford Building A27, The University of Sydney, NSW 2006
Country 130260 0
Australia
Phone 130260 0
+61 2 9351 7220
Fax 130260 0
Email 130260 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


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.