Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000474459p
Ethics application status
Submitted, not yet approved
Date submitted
10/04/2025
Date registered
16/05/2025
Date last updated
16/05/2025
Date data sharing statement initially provided
16/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Symptom checker self-care advice: A mixed-methods evaluation of different presentation formats.
Scientific title
Integrated generative artificial intelligence into symptom checker self-care advice: A mixed-methods evaluation of different presentation formats.
Secondary ID [1] 314029 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fever 336769 0
vomiting 337146 0
Condition category
Condition code
Public Health 333258 333258 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 (acuity level) x5 (framing group) parallel group design of generative AI self-care advice from an online Symptom Checker after participants are told to imagine they are sick (vomiting and fever). Generative AI self-care advice from an online Symptom checker involves inputing the symptoms one is experiencing into the symptom checker to receive tailored care advice about how to best manage the symptoms at home. The generative AI component is used to collate the relevant self-care information for the symptoms and present the relevant information/care to the user in a way that produces plausible human-like output.

Acuity levels:
Arm 1 = Triage advice given to participants will be 'self-care at home'
Arm 2 = Triage advice given to participants will be 'see the GP within 24 hours'

Framing group:
Arm A = Generative AI enhanced version without enhancements shown in Arms B to D
Arm B = Step-by-step care advice - this advice emphasizes the most important next step, in a logical and numbered sequence.
Arm C = Multi-media content - this advice also provides videos and images to increase user engagement with the health advice (for example, a video about how to manage a fever, and a graphic for signs of dehydration). These specific multi-media content are readily available resources. (Image: Healthdirect 2024 https://www.facebook.com/photo.php?fbid=870444085101447&id=100064075893726&set=a.160444812768048&locale=ga_IE Video: MyDr 2024 https://mydr.com.au/first-aid-self-care/how-do-i-manage-a-fever-dr-norman-swan/)
Arm D = Detailed information about AI used in the model

The the duration of the intervention is 2-5 minutes (this reading a vignette the specific health symptoms and reading the symptom checker advice). Adherence to the intervention will be assessed by submission of the survey. The online survey will be designed that request participants to view the symptom checker advice for a minimum of 2 minutes before moving forward through the survey.
Intervention code [1] 330606 0
Behaviour
Comparator / control treatment
the current Symptom checker advice which provides general self-care advice without use of generative AI is the fifth framing group and will be the control in both acuity levels arm 1 and 2.
Control group
Active

Outcomes
Primary outcome [1] 340827 0
Intention to follow self-care advice
Timepoint [1] 340827 0
Time 1 = immediately after the intervention
Primary outcome [2] 340828 0
Intention to see GP in the next 24 hours
Timepoint [2] 340828 0
Time 1 = immediately after intervention
Secondary outcome [1] 445174 0
general trust
Timepoint [1] 445174 0
Time 1 = immediately post intervention
Secondary outcome [2] 445175 0
Recall of the advice
Timepoint [2] 445175 0
Time 1 Immediately post intervention
Secondary outcome [3] 445177 0
Perceptions of advice
Timepoint [3] 445177 0
Time 1 immediately post intervention
Secondary outcome [4] 445178 0
Acceptability
Timepoint [4] 445178 0
Time 1 immediately post intervention.
Secondary outcome [5] 445179 0
Emotional impact of the advice
Timepoint [5] 445179 0
Time 1 immediately post intervention
Secondary outcome [6] 445182 0
Expectations
Timepoint [6] 445182 0
Time 1 - Immediately post intervention
Secondary outcome [7] 445935 0
Symptoms described
Timepoint [7] 445935 0
Time 1- immediately post-intervention
Secondary outcome [8] 446051 0
Recall of advice
Timepoint [8] 446051 0
Time 2 - 2 weeks post intervention
Secondary outcome [9] 446052 0
Brief understanding
Timepoint [9] 446052 0
Time 2 - 2 weeks post intervention
Secondary outcome [10] 446495 0
Emotional trust
Timepoint [10] 446495 0
timepoint 1 - immediately post intervention
Secondary outcome [11] 447629 0
Cognitive trust
Timepoint [11] 447629 0
timepoint 1 - immediately post intervention

Eligibility
Key inclusion criteria
Inclusion criteria for participation in the trial include:

a) Reside in Australia
b) English proficiency
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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)
Participation will be online and hosted by Qualtrics. Participants will be automatically randomised to one of the 10 study groups using the randomiser function in Qualtrics. Qualtrics utilises a randomiser which is based on the Mersenne Twister, a pseudorandom number generator. Therefore researchers will be unaware which participant is allocated into which study arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualtrics utilises a randomiser which is based on the Mersenne Twister, a pseudorandom number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
A total of approximately 2000 participants will be recruited. As we plan a 2 (acuity levels) x 5 (framing group) parallel group design with 90%, alpha = 0.05, and a small effect size, the sample size given by Gpower is n = 160 per group. This totals n=1600 in total. We will also recruit approximately an additional 20% to account for drop-out at follow-up (Time 2).

This data will be analysed with appropriate regression models to test for overall differences in primary and secondary outcomes. To assess for any differences between groups, planned contrasts will also be used, adjusting the significance threshold for multiple pairwise comparisons.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2025
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
14/07/2025
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] 318534 0
Government body
Name [1] 318534 0
HealthDirect Australia
Country [1] 318534 0
Australia
Primary sponsor type
University
Name
Kirsten McCaffery - Sydney Health Literacy Lab, The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321402 0
None
Name [1] 321402 0
Address [1] 321402 0
Country [1] 321402 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317137 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317137 0
Ethics committee country [1] 317137 0
Australia
Date submitted for ethics approval [1] 317137 0
14/02/2025
Approval date [1] 317137 0
Ethics approval number [1] 317137 0
2025/HE000143

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

Contacts
Principal investigator
Name 140122 0
Prof Kirsten McCaffery
Address 140122 0
Sydney Health literacy lab, The University of Sydney, 127A Edward Ford Building, Sydney, NSW, 2006
Country 140122 0
Australia
Phone 140122 0
+61 2 9351 7220
Fax 140122 0
Email 140122 0
[email protected]
Contact person for public queries
Name 140123 0
Kirsten McCaffery
Address 140123 0
Sydney Health Literacy Lab, The University of Sydney, 127A Edward Ford Building, Sydney, NSW, 2006
Country 140123 0
Australia
Phone 140123 0
+61 2 9351 7220
Fax 140123 0
Email 140123 0
[email protected]
Contact person for scientific queries
Name 140124 0
Kirsten McCaffery
Address 140124 0
Sydney Health Literacy Lab, The University of Sydney, 127A Edward Ford Building, Sydney, NSW, 2006
Country 140124 0
Australia
Phone 140124 0
+61 2 9351 7220
Fax 140124 0
Email 140124 0
[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:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Principle Investigator - Professor Kirsten McCaffery: [email protected]

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.