Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000641594
Ethics application status
Approved
Date submitted
3/05/2024
Date registered
20/05/2024
Date last updated
19/07/2024
Date data sharing statement initially provided
20/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating educational interventions to support safe use of ChatGPT for health: a randomised-controlled trial of ChatGPT users
Scientific title
Evaluating educational interventions to support safe use of ChatGPT for health: A randomised-controlled trial of ChatGPT users
Secondary ID [1] 311775 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
general health (not specific to a health condition as this is health literacy skills research) 333282 0
Condition category
Condition code
Public Health 329974 329974 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to receive one of the interventions below, or the comparator.

1. Infographic style information about how to use ChatGPT safely for health questions available as image carousel within the online survey (time to view <5 mins)
2. Short (<5 min) animation about how to use ChatGPT safely for health questions
Content for both interventions covers the potential risks of using ChatGPT for health information, advice about which kinds of health questions may be less risky, and strategies for reducing these risks e.g. accessing multiple information sources.

For all intervention groups including comparator:
Delivered online via online survey in a single instance. Survey completion will be used to monitor adherence.

Time to complete survey is approx 15 minutes.
Intervention code [1] 328228 0
Behaviour
Comparator / control treatment
Participants will view an unrelated infographic (e.g. on healthy eating) available through the online survey software as an image.
Control group
Placebo

Outcomes
Primary outcome [1] 337735 0
Appropriate use of ChatGPT for health questions
Timepoint [1] 337735 0
Single timepoint immediately after exposure to the intervention
Secondary outcome [1] 433005 0
Trust in ChatGPT
Timepoint [1] 433005 0
Single timepoint immediately after exposure to the intervention
Secondary outcome [2] 433009 0
Knowledge of ChatGPT
Timepoint [2] 433009 0
Single timepoint immediately after exposure to the intervention

Eligibility
Key inclusion criteria
Adults (18+) years, based in Australia, who self-report having used ChatGPT at least a few times in the past 6 months. A minimum 50% of participants will have less than university level of education
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who report that they have not used ChatGPT at least a few times in the past 6 months.

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)
central randomisation (Qualtrics platform)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) - (Qualtrics platform Mersenne Twister, 1:1:1 ratio)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be conducted using planned contrasts between the two 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 567. This is based on an expected small effect size of 0.15 for the primary outcome. The number of participants required per arm (3 arms), to provide 90% power at error type I (alpha of 0.05) is 189 (this is a balanced design).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2024
Actual
5/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
567
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316107 0
Government body
Name [1] 316107 0
National Health and Medical Research Council
Country [1] 316107 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318276 0
None
Name [1] 318276 0
Address [1] 318276 0
Country [1] 318276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314940 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314940 0
Ethics committee country [1] 314940 0
Australia
Date submitted for ethics approval [1] 314940 0
Approval date [1] 314940 0
13/03/2024
Ethics approval number [1] 314940 0

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

Contacts
Principal investigator
Name 133186 0
Dr Julie Ayre
Address 133186 0
Edward Ford Building (A27), Physics Rd, The University of Sydney , NSW 2006
Country 133186 0
Australia
Phone 133186 0
+61 293517789
Fax 133186 0
Email 133186 0
[email protected]
Contact person for public queries
Name 133187 0
Julie Ayre
Address 133187 0
Edward Ford Building (A27), Physics Rd, The University of Sydney , NSW 2006
Country 133187 0
Australia
Phone 133187 0
+61 293517789
Fax 133187 0
Email 133187 0
[email protected]
Contact person for scientific queries
Name 133188 0
Julie Ayre
Address 133188 0
Edward Ford Building (A27), Physics Rd, The University of Sydney , NSW 2006
Country 133188 0
Australia
Phone 133188 0
+61 293517789
Fax 133188 0
Email 133188 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
deidentified data underlying published results
When will data be available (start and end dates)?
available after publication of the manuscript, no end date to when the data will no longer be available.
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any
How or where can data be obtained?
publicly available data (email principal investigator [email protected])


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.