Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001297617
Ethics application status
Approved
Date submitted
16/11/2023
Date registered
13/12/2023
Date last updated
13/12/2023
Date data sharing statement initially provided
13/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring workforce capability and capacity in communicating with people living with dementia (PLWD) using an artificially intelligent (AI) avatar “Talk with Ted”.
Scientific title
Exploring workforce capability and capacity in communicating with people living with dementia (PLWD) using an artificially intelligent (AI) avatar “Talk with Ted”.
Secondary ID [1] 310964 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impairment of brain function 332049 0
Dementia 332231 0
Condition category
Condition code
Neurological 328773 328773 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Dementia Australia “Talk with Ted” avatar training.
a. What it involves: “Talk with Ted” uses artificial intelligence (AI) technology to provide an online simulation of a typical communication experience between a care worker and someone living with dementia. Ted, the AI avatar, is living with dementia and conveys a range of emotions and verbal responses during the simulation, providing care workers the opportunity to work through a common challenging scenario, for example, providing personal care such as a shower.
'Talk with Ted' involves a one training session of 1-hour and is completed individually online via a computer.
The training will be undertaken by healthcare workers who interact with people living with dementia, including nurses, personal care workers, clinical team leaders, support staff (allied health professionals and lifestyle personnel), and managers.
Monitoring of adherence will be undertaken by researchers overseeing the completion of the training on-site at the included facilities. This will involve setting up the computers and maintaining a presence to address any technical issues that may arise. Additionally, operator usage data will be captured.
Intervention code [1] 327403 0
Behaviour
Comparator / control treatment
Standard online training.
The standard training program comprises a module titled Communicating in a Person-Centred Way developed by Dementia Australia, and it will be completed individually online via a computer. The focus of the standard online module is (1) the importance of communication within the support relationship; (2) the barriers to positive communication; (3) the impact of dementia on the person’s ability to communicate; (4) supporting person-centred communication through support relationships, and (5) individualised strategies for communication. The module takes approximately 1-hour to complete and is undertaken in a single session. Monitoring of adherence will be undertaken by researchers overseeing the completion of the training on-site at the included facilities. This will involve setting up the computers and maintaining a presence to address any technical issues that may arise. Additionally, operator usage data will be captured.
Control group
Active

Outcomes
Primary outcome [1] 336589 0
Evaluate the impact of using 'Talk with Ted' interactive online training to promote the communication skills of professional staff participants working in aged care.
Composite measures.
Timepoint [1] 336589 0
Observation: During completion of 'Talk with Ted' training, observational data will be collected of individual's responses when completing the 'Talk with Ted' avatar training; conversation logs recorded during interaction with 'Talk with Ted' will be captured.
Interview: approximately 2 months after the 'Talk with Ted' or standard online training is completed.
Survey completed immediately post-completion of training for both 'Talk with Ted'.
Primary outcome [2] 336740 0
Evaluate professional staff participants' perceptions of the training experience ('Talk with Ted' avatar or standard online training).
Timepoint [2] 336740 0
Baseline survey: Immediately prior to commencing the training.
Post-intervention survey: Immediately following completion of the training.
Secondary outcome [1] 429533 0
Evaluate the impact of the 'Talk with Ted' training incident reports of aggression expressed by people living with dementia.
Timepoint [1] 429533 0
Incident data for 12 months retrospectively prior to commencement of participant training, and for 6 months prospectively from the time all participants within the facility have completed the training.

Eligibility
Key inclusion criteria
Professional care staff employed at the participating aged care facilities/homes who have at least 6-months of experience interacting with people living with dementia will be eligible to participate. Professional care staff may include:
• Personal care workers
• Lifestyle workers
• Health professionals such as nursing and allied health professionals
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
To ensure participants can complete the research requirements, professional care staff with less than 6 months of experience interacting with people living with dementia, and those who have previous experience with the Dementia Australia Training Avatar (Talk with Ted) will be ineligible to participate in 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)
Central randomisation
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
200 participants to pilot “Talk with Ted” to inform implementation and methodology, including sample size calculations, for a definitive effectiveness study in the future.
Quantitative: 1) Surveys: Descriptive statistics, including frequency distribution, measures of central tendency (e.g., means, medians, and mode) measures of variability (e.g., standard deviations, interquartile ranges) will be used to describe the quantitative data. We will use the User Experience Questionnaire (UEQ) Guide (Handbook.pdf (ueq-online.org) instructions for analysis of the UEQ data to calculate scale mean scores, standard deviations, variance scale consistency (Cronbach’s alpha and Guttmans Lambda2) coefficients. For the AIM, IAM and FIM we will follow the authors instructions for calculation of mean scale scores (Triple P System Implementation Outcomes_Acceptability, Appropriateness, Feasibility.pdf (unc.edu)). T-tests will be used to compare mean scale scores between groups. Descriptive statistics will be used to analyse the data on participants’ rating of the extent to which the training addressed emotional goals and the data resulting from the DA Training Avatar Questionnaire. 2) Scoring of the avatar use observations will be undertaken during data collection. The highest possible score is 21. These data will be analysed descriptively, using frequencies and by calculating mean scores. 3) Incident frequency data will be graphed to identify trends. It is unlikely there will be sufficient data to undertake more sophisticated analyses, such as time series analysis.
Qualitative: 1) Content analysis of the conversation logs recorded during participant interactions with “Ted” will be conducted. The data will be analysed for recurring words or themes to identify consistencies and differences. A matrix (affinity diagram) will then be used to organize the data to identify and group patterns by related themes, and to identify hierarchies to draw out higher-level concepts. 2) The interview transcripts will be de-identified, coded and analysed using thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2023
Actual
Date of last participant enrolment
Anticipated
29/03/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315221 0
Government body
Name [1] 315221 0
Flinders University (Aged Care Research & Industry Innovation Australia (ARIIA))
Country [1] 315221 0
Australia
Primary sponsor type
Government body
Name
Aged Care Research & Industry Innovation Australia (ARIIA)
Address
Tonsley Hub, Level 2/1284 South Rd, Tonsley SA 5042
Country
Australia
Secondary sponsor category [1] 317264 0
None
Name [1] 317264 0
Address [1] 317264 0
Country [1] 317264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314146 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 314146 0
Ethics committee country [1] 314146 0
Australia
Date submitted for ethics approval [1] 314146 0
30/05/2023
Approval date [1] 314146 0
24/10/2023
Ethics approval number [1] 314146 0
HREC/97951/VICBH-2023-385448(v2)

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

Contacts
Principal investigator
Name 130578 0
Prof Alison Hutchinson
Address 130578 0
Deakin University, 1 Gheringhap St, Geelong, Vic, 3220
Country 130578 0
Australia
Phone 130578 0
+61 0392446446
Fax 130578 0
Email 130578 0
[email protected]
Contact person for public queries
Name 130579 0
Alison Hutchinson
Address 130579 0
Deakin University, 1 Gheringhap St, Geelong, Vic, 3220
Country 130579 0
Australia
Phone 130579 0
+61 0392446446
Fax 130579 0
Email 130579 0
[email protected]
Contact person for scientific queries
Name 130580 0
Alison Hutchinson
Address 130580 0
Deakin University, 1 Gheringhap St, Geelong, Vic, 3220
Country 130580 0
Australia
Phone 130580 0
+61 0392446446
Fax 130580 0
Email 130580 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
No identifiable data will be collected in the surveys, and data collected from the interviews will be de-identified before analysis.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20933Ethical approval  [email protected] Noted within publication.



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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