Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000523404
Ethics application status
Approved
Date submitted
2/05/2025
Date registered
26/05/2025
Date last updated
26/05/2025
Date data sharing statement initially provided
26/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring perceptions of an artificial intelligence tool for health information.
Scientific title
Exploring the Impacts of Artificial Intelligence (AI) Warmth and Competence on User Trust for Health Information
Secondary ID [1] 314278 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 337215 0
Condition category
Condition code
Cardiovascular 333625 333625 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention/s employed in this study target the perceptions of warmth and competence in AI systems which participants will use to learn about atrial fibrillation.
The study will employ a between-subjects 2x2 design:
Variable 1 - Competence (perceived; high vs. low): participants will be randomised to read one of two text-based descriptions of an AI agent, one emphasising the agent’s intelligence, accuracy and capabilities, the other a more general description with no competence descriptors.
Variable 2 - Warmth (high vs. low): after reading the competence description, participants will be randomly allocated to receive one of two private access links to distinct Cogniti agents (Cogniti is a site developed by the University of Sydney for people to design AI agents). These agents have differing system messages which have been written by the research team to instruct the agent of the characteristics to express and conversational styles to adopt during interactions. The high warmth agent expresses high social orientation in its conversational style. The low warmth agent has a direct and emotionally neutral conversational style, adopting the persona of a web-based search rather than a conversational agent. Other than the conversational styles and benevolence level, the agents are identical.

The resulting groups will be:
High competence x high warmth
High competence x low warmth
Low competence x high warmth
Low competence x low warmth = active control group

Participants will be randomly allocated to read a high- or low- competence text-based description. These descriptions are quite short and we anticipate that participants will require less than one minute of reading time. These descriptions will be administered within the survey via Qualtrics, not by any specific member of a research team.

To ensure sufficient interaction with the AI agent, the participants will not be able to proceed with the experiment until five minutes has passed. Ongoing pilot testing has confirmed that this is sufficient time, and has indicated that at least five meaningful questions should be asked to obtain sufficient information. Transcripts will therefore be checked upon submission for evidence of this sufficient engagement (i.e. at least five questions asked).

Participants will be provided with the following instruction to prompt their interaction with the AI agent: "Please spend five minutes using this agent to get a good understanding of atrial fibrillation. Read its responses carefully. You could ask about what the disease is, its symptoms, causes, diagnosis and treatments, and what life looks like with the disease."

Information provided by the agents are entirely text-based. The high-warmth agent does use emoticons to communicate the social orientation, and the low-warmth agent does not. The interactions will all occur within the single session and the agent is not accessible by the participants outside this time window. Participants will access the study from their personal devices in a location of their choosing, wherever they have access to the internet. There will not be any in person sessions.

To monitor the adherence to the intervention, we will be collecting manipulation confirmation responses (twelve items that measure warmth and competence), and will be conducting a sentiment analysis using Linguistic Inquiry and Word Count (LIWC) Analysis for the AI outputs and if applicable the questions that the participants ask the AI.

Pilot Testing clarification:
Informal pilot testing will be conducted with a distinct cohort, none of whom will be completing the actual survey. This will occur before recruitment into the study commences. The purpose of the pilot testing is to identify technological and administrative issues only, particularly with logging into Cogniti and accessing the agents. We are anticipating including 16 individuals in this informal pilot testing. The data obtained in this informal pilot testing will not be included in any data analysis in the general study.
Intervention code [1] 330889 0
Behaviour
Comparator / control treatment
The low-competence (LC) x low-warmth (LW) group acts as the control groups. This is an active control group as the participants will be interacting with a Cogniti agent.
Control group
Active

Outcomes
Primary outcome [1] 341200 0
Trust in AI Agent
Timepoint [1] 341200 0
Immediately after interaction with the AI agent.
Primary outcome [2] 341201 0
Intention to Use
Timepoint [2] 341201 0
Immediately after interaction with the AI agent.
Primary outcome [3] 341202 0
Atrial Fibrillation Knowledge
Timepoint [3] 341202 0
Immediately after interaction with the AI agent.
Secondary outcome [1] 446763 0
Manipulation Confirmation - Competence
Timepoint [1] 446763 0
Immediately after the AI agent interaction.
Secondary outcome [2] 447418 0
Manipulation Confirmation - Warmth
Timepoint [2] 447418 0
Immediately after the AI interaction.

Eligibility
Key inclusion criteria
Participants will be sourced from the University of Sydney's SONA systems participation pool. Participants on this system are often undergraduate students who complete research for course credit.

Participants must have a sufficient English language ability for engaged participation with the AI agents.

Data will only be used if participants submit a transcript of their interaction with the AI agent that indicates substantial interaction (i.e. more than five questions asked - to be confirmed from pilot testing).
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants with an existing knowledge of atrial fibrillation will not be included as this may bias results and impact their interaction with the agent (this refers to a clinical knowledge held by current/past medical professionals).

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)
Allocation occurs in Qualtrics, embedded in the survey completed by participants. Participants will not know about groups or that there is an intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer software (Qualtrics)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
5/09/2025
Actual
Date of last data collection
Anticipated
5/09/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318796 0
Self funded/Unfunded
Name [1] 318796 0
Country [1] 318796 0
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321242 0
None
Name [1] 321242 0
Address [1] 321242 0
Country [1] 321242 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317404 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317404 0
Ethics committee country [1] 317404 0
Australia
Date submitted for ethics approval [1] 317404 0
16/04/2025
Approval date [1] 317404 0
20/05/2025
Ethics approval number [1] 317404 0

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

Contacts
Principal investigator
Name 140954 0
Dr Julie Ayre
Address 140954 0
Edward Ford Building, A27 Fisher Rd, University of Sydney, NSW, 2050
Country 140954 0
Australia
Phone 140954 0
+61 02 93517788
Fax 140954 0
Email 140954 0
[email protected]
Contact person for public queries
Name 140955 0
Julie Ayre
Address 140955 0
Edward Ford Building, A27 Fisher Rd, University of Sydney, NSW, 2050
Country 140955 0
Australia
Phone 140955 0
+61 02 93517788
Fax 140955 0
Email 140955 0
[email protected]
Contact person for scientific queries
Name 140956 0
Julie Ayre
Address 140956 0
Edward Ford Building, A27 Fisher Rd, University of Sydney, NSW, 2050
Country 140956 0
Australia
Phone 140956 0
+61 02 93517788
Fax 140956 0
Email 140956 0
[email protected]

Data sharing statement
Will the study consider sharing 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.