Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001326189
Ethics application status
Approved
Date submitted
11/09/2019
Date registered
27/09/2019
Date last updated
8/01/2020
Date data sharing statement initially provided
27/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Healthcare Robot Study: The effect of robot social behaviours on human-robot interactions
Scientific title
The healthcare robot study: The effect of robot behaviour on human-robot interactions
Secondary ID [1] 299174 0
None
Universal Trial Number (UTN)
None
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Perceived Empathy
Engagement 314267 0
Condition category
Condition code
Public Health 312622 312622 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will engage in a scripted interaction with an ‘Eve-R’ robot during which they will ask the robot questions from a set script. This initial interaction will take place in a simulated general practice clinic environment and will involve the participant asking the robot to tell them about the medical practice and the robot responding to this request. This interaction will take approximately 5 minutes. The purpose of this initial interaction is to minimise any novelty effects that come with interacting with a robot for the first time.

Immediately following the initial interaction, participants will be randomised to one of two conditions: a condition in which the robot will use humour during the interaction or a condition in which humour will be absent. Aside from the use of humour, all other aspects of this interaction, and the robots’ responses, will be identical. During these interactions, participants will read from an identical script and will ask the robot about ways in which they can protect themselves from getting the flu. This interaction will also take approximately 5 minutes. The robot will respond with a number of ways in which this goal can be achieved and will ask the participant questions during the course of the interaction. A Post-Interaction Questionnaire will be completed following each interaction which will measure participant ratings of robot likability, intelligence, animacy, safety, empathy, and anthropomorphism, between the neutral and intervention groups.
Intervention code [1] 315468 0
Behaviour
Comparator / control treatment
The neutral condition will be identical to the humour condition in terms of the participant's script. The robot's speech will be identical in both the humour and neutral conditions, aside from the fact that the robot will not use humour statements in the neutral condition.
Control group
Active

Outcomes
Primary outcome [1] 321277 0
Participant ratings of robot likability, intelligence, animacy, safety and anthropomorphism will be measured using the "Godspeed Questionnaire Series (GQS)" one of the most frequently used questionnaires in the field of Human-Robot Interaction.
Timepoint [1] 321277 0
All measures will be administered immediately following the initial interaction with the robot and again immediately following the second interaction with the robot.
Primary outcome [2] 321456 0
Empathy - Empathy will be assessed using an adaption of the McGill Friendship Questionnaire (Mendelson & Aboud, 1999), along with an adaption of the Consultation and Relational Empathy measure (CARE measure)
Timepoint [2] 321456 0
All measures will be administered immediately following the initial interaction with the robot and again immediately following the second interaction with the robot.
Secondary outcome [1] 374512 0
Participant behaviour (i.e. do participants laugh more in the interaction with the humourous healthcare robot than when compared to the interaction with the neutral healthcare robot).
Timepoint [1] 374512 0
Participants will be video recorded and behaviour will be coded and analysed following the completion of the randomised interaction with the robot.

Eligibility
Key inclusion criteria
Participants will need to be over the age of 16 years and will need to be fluent in English in order to participate in the study.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals below the age of 16 years and/or those individuals who are not fluent in English will be excluded from the study.

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)
Yes. A randomisation algorithm with be used in order to randomise participants to either the neutral or humour condition. The randomisation codes for each participant will be sealed in an opaque envelope which will be opened by the researcher immediately prior to the participant beginning the second interaction with the robot. The researcher will then use the code to select the correct interaction for the robot to undertake. .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Note - this study is with healthy participants in a university setting. We are interested in whether the robot's use of humour improves the interaction between the participant and the robot, as measured by questionnaires and participant behaviour. There is no treatment involved. The robots are simply talking with the participants. The only health outcome is the person's perception of the robot and the interaction, and their behaviour during the interaction.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The two groups will be compared on changes to perceptions using ANCOVA analysis controlling for initial values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/09/2019
Date of last participant enrolment
Anticipated
25/10/2019
Actual
31/10/2019
Date of last data collection
Anticipated
1/11/2019
Actual
31/10/2019
Sample size
Target
90
Accrual to date
Final
91
Recruitment outside Australia
Country [1] 21833 0
New Zealand
State/province [1] 21833 0
Auckland

Funding & Sponsors
Funding source category [1] 303717 0
Other
Name [1] 303717 0
Korea Institute of Science and Technology
Country [1] 303717 0
Korea, Democratic People's Republic Of
Primary sponsor type
University
Name
The University of Auckland
Address
314-390 Khyber Pass Rd
Newmarket
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 303831 0
None
Name [1] 303831 0
Address [1] 303831 0
Country [1] 303831 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304242 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 304242 0
Ethics committee country [1] 304242 0
New Zealand
Date submitted for ethics approval [1] 304242 0
02/09/2019
Approval date [1] 304242 0
04/09/2019
Ethics approval number [1] 304242 0
023487

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

Contacts
Principal investigator
Name 96254 0
Prof Elizabeth Broadbent
Address 96254 0
Auckland Hospital - Bldg 599
Level 12, Room 12005
2 Park Road
Grafton
Auckland 1023
Country 96254 0
New Zealand
Phone 96254 0
+64 9 923 6756
Fax 96254 0
Email 96254 0
[email protected]
Contact person for public queries
Name 96255 0
Deborah Johanson
Address 96255 0
Auckland Hospital - Bldg 599
Level 12, Room 12005
2 Park Road
Grafton
Auckland 1023
Country 96255 0
New Zealand
Phone 96255 0
+64 9 923 6756
Fax 96255 0
Email 96255 0
[email protected]
Contact person for scientific queries
Name 96256 0
Elizabeth Broadbent
Address 96256 0
Auckland Hospital - Bldg 599
Level 12, Room 12005
2 Park Road
Grafton
Auckland 1023
Country 96256 0
New Zealand
Phone 96256 0
+64 9 923 6756
Fax 96256 0
Email 96256 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
In order to protect the confidentiality of participants, individual data will not be shared.


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.