Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000230853
Ethics application status
Approved
Date submitted
5/11/2020
Date registered
4/03/2021
Date last updated
1/03/2023
Date data sharing statement initially provided
4/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Dementia Training for Physiotherapy Practitioners and Students using Artificial Intelligence-Enhanced Virtual Reality Technology
Scientific title
Feasibility and Acceptability of an Artificial Intelligence-Enhanced Virtual Reality Dementia Training Program for Physiotherapy Practitioners and Students
Secondary ID [1] 302707 0
None
Universal Trial Number (UTN)
U1111-1260-8432
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 319621 0
Condition category
Condition code
Neurological 317564 317564 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An AI-enhanced VR dementia training program will be developed and pilot tested with physiotherapy students and practitioners. The scenario developed for the study will be a 'virtual' physiotherapy treatment session with a patient with dementia, conducted in a physiotherapy gym in a hospital. The treatment scenario will involve the physiotherapist avatar leading the patient avatar through a series of tests and exercises, such as mobilising around cones and stepping up on to a step in the parallel bars. The trainees (physiotherapists and physiotherapy students) will wear a VR headset to experience the dementia training program. There will be the possibility for trainees to experience the scenario from both the patient and physiotherapist perspectives. The scenario will be developed to use with the Oculus Rift S VR headsets to aid portability and increase the level of immersion of the training experience. The Oculus Rift S VR headset is the most powerful PC-powered gaming VR headset and was co-developed by Lenovo Technologies and Oculus. The trainee wears the headset over their eyes and it is held in place by a 'halo' headband that fits around their head. The scenario developed for this study will use AI to facilitate greater interaction of the trainee during training; changes to the avatar such as gender, culture and behaviour that represent the diverse population of people with dementia and the different types of dementia. The VR training program will run for approximately 10 minutes and will only be completed once by participants. Participants will not include people with dementia. Feedback on the training program will be collected via a post-workshop survey competed by participants when they have completed their pilot test of the training program.
Intervention code [1] 318988 0
Behaviour
Intervention code [2] 319880 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325609 0
Feasibility of the AI-enhanced VR dementia training program as assessed by examination of recruitment and questionnaire completion rates for the pilot test.
Timepoint [1] 325609 0
Recruitment rates will be collected at baseline
Survey completion rates collected at all three timepoints (baseline, immediately after completion of the pilot test [within 24 hours of completing the pilot test], and 3 month follow up after the pilot test)
Primary outcome [2] 325610 0
Acceptability of the AI-enhanced VR dementia training program as assessed by
(i) feedback from participants collected during post-test questionnaire developed specifically for this study, and
(ii) focus group with participants that consent to participate in this stage of the study. Each focus group will involve 8-12 participants, run for 60 minutes, will be audio-recorded, and include open-ended questions as well as participant led discussion on the use of virtual reality for education purposes in health care. The final numbers of focus groups will be dependent on recruitment (which will occur during completion of the post-workshop survey).
Timepoint [2] 325610 0
Post-test questionnaire - immediately after completion of the pilot test (within 24 hours of completing the pilot test)
Secondary outcome [1] 388554 0
Attitudes towards dementia as assessed by the Dementia Attitudes Scale (DAS)
Timepoint [1] 388554 0
Baseline, immediately after the pilot test (within 24 hours of completion of the pilot test), 3 months after completion of the pilot test.
Secondary outcome [2] 388555 0
Empathy towards people with dementia as assessed by the Medical Condition Regard Scale (MCRS)
Timepoint [2] 388555 0
Baseline, immediately after the pilot test (within 24 hours of completion of the pilot test), 3 months after completion of the pilot test.
Secondary outcome [3] 388556 0
Sense of competence in dementia care practice as assessed by the Sense of Competence in Dementia Care Staff (SCIDS) scale
Timepoint [3] 388556 0
Baseline, immediately after the pilot test (within 24 hours of completion of the pilot test), 3 months after completion of the pilot test.

Eligibility
Key inclusion criteria
-Able to provide written consent
- Either employed as a physiotherapist at POW hospital and based on one of the aged care wards, or
- A current Doctor of Physiotherapy student at Macquarie University, NSW, Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Unable to communicate in English at a level that supports them to participate in a focus group.
- Pregnant
- Pre-existing binocular vision abnormalities (e.g. diplopia)
- Vertigo, severe motion sickness or other motion or balance impairments that may effect ability to participate in the VR experience

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size (n=15) was determined based on experience of members of the research team who had conducted multiple pilot tests with VR technology similar to that used in this project.

Analysis plan:
Data collected in the focus groups will be recorded and transcribed using Microsoft Teams, and then thematically analysed by three members of the research team. These findings, along with questionnaire data and other outcome measures, will be used to inform program development and determine feasibility and acceptability of the program..

Descriptive statics and the repeated-measure ANOVA or Kruskal-Wallis test (depending on data distribution) will be used for analysis of the questionnaires to provide preliminary evidence on the impact of the program on dementia empathy, attitudes, and sense of competence. Statistical analysis will be conducted using SPSS.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2021
Actual
21/03/2022
Date of last participant enrolment
Anticipated
30/07/2021
Actual
5/04/2022
Date of last data collection
Anticipated
28/01/2022
Actual
27/07/2022
Sample size
Target
15
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17958 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 31832 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307140 0
University
Name [1] 307140 0
Macquarie University
Country [1] 307140 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
c/o Lindsey Brett
Department of Health Professions
Faculty of Medicine, Health and Human Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 307724 0
Hospital
Name [1] 307724 0
Prince of Wales Hospital
Address [1] 307724 0
Physiotherapy Department
Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country [1] 307724 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307252 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 307252 0
Ethics committee country [1] 307252 0
Australia
Date submitted for ethics approval [1] 307252 0
10/07/2020
Approval date [1] 307252 0
22/10/2020
Ethics approval number [1] 307252 0
2020/ETH00833
Ethics committee name [2] 307254 0
Macquarie University Human Research Ethics Committee
Ethics committee address [2] 307254 0
Ethics committee country [2] 307254 0
Australia
Date submitted for ethics approval [2] 307254 0
29/10/2020
Approval date [2] 307254 0
22/01/2021
Ethics approval number [2] 307254 0
52020925822167

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

Contacts
Principal investigator
Name 106574 0
Dr Lindsey Brett
Address 106574 0
Department of Health Professions
Faculty of Medicine, Health and Human Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 106574 0
Australia
Phone 106574 0
+61 2 9850 2487
Fax 106574 0
Email 106574 0
[email protected]
Contact person for public queries
Name 106575 0
Lindsey Brett
Address 106575 0
Department of Health Professions
Faculty of Medicine, Health and Human Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 106575 0
Australia
Phone 106575 0
+61 2 9850 2487
Fax 106575 0
Email 106575 0
[email protected]
Contact person for scientific queries
Name 106576 0
Lindsey Brett
Address 106576 0
Department of Health Professions
Faculty of Medicine, Health and Human Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 106576 0
Australia
Phone 106576 0
+61 2 9850 2487
Fax 106576 0
Email 106576 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
As per the consent form and protocol document no individual participant data will be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9635Ethical approval    380879-(Uploaded-03-02-2021-15-01-53)-Study-related document.pdf



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.