Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001095156
Ethics application status
Approved
Date submitted
24/07/2019
Date registered
9/08/2019
Date last updated
1/03/2023
Date data sharing statement initially provided
9/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of virtual reality training on allied health professional’s knowledge and perception of dementia
Scientific title
Impact of virtual reality training on allied health professional’s knowledge and perception of dementia
Secondary ID [1] 298774 0
Nil known
Universal Trial Number (UTN)
U1111-1237-2289
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 313718 0
Condition category
Condition code
Neurological 312126 312126 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enabling EDIE (Educational Dementia Immersive Experience) Acute Workshop:
The Enabling EDIE Acute Workshop is a one hour Virtual Reality (VR) training workshop developed by Dementia Australia in consultation with people with dementia and their carers to specifically simulate the experience of having dementia and targeted towards healthcare professionals that work in acute care settings. The workshop is provided by accredited trainers from Dementia Australia face to face in a group setting (up to 15 participants). The trainers hold a Certificate 4 in assessment and training and have a clinical background. The workshops can be provided in a location suitable for those attending (e.g. work environment). The Enabling EDIE workshop aims to increase knowledge, change attitudes and improve care practices.

The workshop involve a multisensory, virtual simulation of light, sound, colour, and visual content that allows participants to experience the cognitive and perceptual difficulties faced by those with dementia (a negative experience of a scenario). This involves the use of VR headsets by participants. The workshops also allow for group discussions about environmental factors which impact a person with dementia and strategies health care professionals and carers can adopt to support a person with dementia. Specific examples from the group's work environment (e.g. hospital ward) are used.

There will be seven workshops conducted for the purpose of this study.
Intervention code [1] 315041 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320761 0
Change in score on the Dementia Knowledge Assessment Scale (within the study survey)
Timepoint [1] 320761 0
Three time points:
- Pre-workshop (one week prior to attending the workshop)
- Post-workshop (immediately after completion of the workshop) - primary timepoint
- Follow-up (three months after completion of the workshop)
Primary outcome [2] 320762 0
Change in attitude as determined using the Dementia Attitudes Scale (within the study survey)
Timepoint [2] 320762 0
Three time points:
- Pre-workshop (one week prior to attending the workshop)
- Post-workshop (immediately after completion of the workshop) - primary timepoint
- Follow-up (three months after completion of the workshop)
Primary outcome [3] 320763 0
Change in perception of dementia care as determined using the Sense of Competence in Dementia Care Staff Scale (within the study survey)
Timepoint [3] 320763 0
Three time points:
- Pre-workshop (one week prior to attending the workshop)
- Post-workshop (immediately after completion of the workshop) - primary timepoint
- Follow-up (three months after completion of the workshop)
Secondary outcome [1] 372759 0
Participant-percevied barriers (potential and actual) to the provision of dementia care as assessed by survey questions designed specifically for the study.
Timepoint [1] 372759 0
Three time points:
- Pre-workshop (one week prior to attending the workshop)
- Post-workshop (immediately after completion of the workshop)
- Follow-up (three months after completion of the workshop)
Secondary outcome [2] 372760 0
Participant-reported strategies (otential and actual) implemented to improve the provision of dementia care as assessed by survey questions designed specifically for the study.
Timepoint [2] 372760 0
Three time points:
- Pre-workshop (one week prior to attending the workshop)
- Post-workshop (immediately after completion of the workshop)
- Follow-up (three months after completion of the workshop)
Secondary outcome [3] 372761 0
Overall satisfaction of the Enabling EDIE Workshop as assessed by survey questions designed specifically for the study. This will be a composite measure of the following: overall satisfaction of the Enabling EDIE workshop, components of training that worked best and improvements that could be made to training.
Timepoint [3] 372761 0
Two time points: Post-workshop (survey immediately after completion of the workshop), Follow-up (survey three months after completion of the workshop)
Secondary outcome [4] 373277 0
Overall opinion on the use of VR in healthcare training as assessed by survey questions designed specifically for the study.
Timepoint [4] 373277 0
Two time points: Post-workshop (survey immediately after completion of the workshop), Follow-up (survey three months after completion of the workshop).
Secondary outcome [5] 373278 0
Impact of the Enabling EDIE workshop on clinical practice (actual and potential) as assessed by survey questions designed specifically for the study.
Timepoint [5] 373278 0
Two time points: Post-workshop (survey immediately after completion of the workshop), Follow-up (survey three months after completion of the workshop).

Eligibility
Key inclusion criteria
- Work regularly (either in a paid position or on placement as a student) with individuals with dementia.
- Employed as either an Allied Health Professional (AHP) or an Allied Health Assistant (AHA) within South East Sydney Local Health District (SESLHD), or a current student at Macquarie University’s doctorate of physiotherapy program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Previously attended the Enabling EDIE workshop.

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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size:
Sample size has been determined based on the number of workshops the researchers were able to book with the allocated funding. Seven Enabling EDIE workshops will be conducted by Dementia Australia (based on the allocated funding), which will provide a sample size of approximately 105 participants.

Statistical Analysis Plan:
In order to address the study objectives, descriptive analyses and regression modelling of survey data will be used to examine the associations between study variables, such as participant demographics, dementia knowledge and perceptions of dementia. Associations between participant variables (such as type of profession, level of experience) and dementia knowledge and perception responses will be considered using repeated measures probit regression (binary for nominal data and ordered probit for ordinal scales). To determine the effect of the Enabling EDIE workshop over time, changes in dementia knowledge and perceptions will be considered across the different timepoints. This will include comparisons between different groups, such as allied health professions and different levels of experience. The primary test of effectiveness of the Enabling EDIE workshop will be a Wald test of the joint significance of post-workshop time and all associated interactions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2020
Actual
19/01/2021
Date of last participant enrolment
Anticipated
13/07/2021
Actual
23/03/2021
Date of last data collection
Anticipated
30/09/2021
Actual
11/07/2021
Sample size
Target
105
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14246 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 14247 0
War Memorial Hospital - Waverley
Recruitment hospital [3] 14248 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [4] 19794 0
St George Hospital - Kogarah
Recruitment hospital [5] 19795 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 27243 0
2031 - Randwick
Recruitment postcode(s) [2] 27244 0
2024 - Waverley
Recruitment postcode(s) [3] 27245 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 34442 0
2217 - Kogarah
Recruitment postcode(s) [5] 34443 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 303327 0
Charities/Societies/Foundations
Name [1] 303327 0
Prince of Wales Hospital Foundation
Country [1] 303327 0
Australia
Funding source category [2] 303328 0
Other Collaborative groups
Name [2] 303328 0
Health Education and Training Institute
Country [2] 303328 0
Australia
Funding source category [3] 303329 0
Hospital
Name [3] 303329 0
War Memorial Hospital
Country [3] 303329 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital (SESLHD)
Address
Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 303352 0
Hospital
Name [1] 303352 0
War Memorial Hospital
Address [1] 303352 0
125 Birrell Street
Waverley
NSW 2024
Country [1] 303352 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303861 0
South East Sydney Local Health District HREC
Ethics committee address [1] 303861 0
Ethics committee country [1] 303861 0
Australia
Date submitted for ethics approval [1] 303861 0
17/07/2019
Approval date [1] 303861 0
27/08/2019
Ethics approval number [1] 303861 0
2019/ETH12158
Ethics committee name [2] 308860 0
Macquarie University Human Research Ethics Committee
Ethics committee address [2] 308860 0
Ethics committee country [2] 308860 0
Australia
Date submitted for ethics approval [2] 308860 0
17/09/2020
Approval date [2] 308860 0
23/10/2020
Ethics approval number [2] 308860 0
52020790522091

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

Contacts
Principal investigator
Name 95054 0
Dr Lindsey Brett
Address 95054 0
Physiotherapy Department,
Prince of Wales Hospital,
320-346 Barker Street,
Randwick,
NSW 2031,

and

Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109
Country 95054 0
Australia
Phone 95054 0
+61 298502487
Fax 95054 0
Email 95054 0
[email protected]
Contact person for public queries
Name 95055 0
Lindsey Brett
Address 95055 0
Physiotherapy Department,
Prince of Wales Hospital,
320-346 Barker Street,
Randwick,
NSW 2031,

and

Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109
Country 95055 0
Australia
Phone 95055 0
+61 298502487
Fax 95055 0
Email 95055 0
[email protected]
Contact person for scientific queries
Name 95056 0
Lindsey Brett
Address 95056 0
Physiotherapy Department,
Prince of Wales Hospital,
320-346 Barker Street,
Randwick,
NSW 2031,

and

Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109
Country 95056 0
Australia
Phone 95056 0
+61 298502487
Fax 95056 0
Email 95056 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
Non-identifiable, group data will be presented in publications and reports publicly available only to maintain confidentiality of participants and adhere to requirement of type of consent gained for this study (extended consent).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3221Study protocol    377999-(Uploaded-18-07-2019-11-09-12)-Study-related document.pdf
3222Statistical analysis plan  [email protected] Available on request
3223Informed consent form    377999-(Uploaded-18-07-2019-11-12-49)-Study-related document.pdf
3224Informed consent form    377999-(Uploaded-18-07-2019-11-14-00)-Study-related document.pdf
3225Clinical study report    Will be added once study completed
3226Ethical approval    Will be added once received
3227Other    Survey questions 377999-(Uploaded-18-07-2019-11-18-22)-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.