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Trial registered on ANZCTR


Registration number
ACTRN12619001510134
Ethics application status
Approved
Date submitted
17/10/2019
Date registered
31/10/2019
Date last updated
3/05/2023
Date data sharing statement initially provided
31/10/2019
Date results provided
3/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of reminiscence therapy using virtual reality in residential aged care to improve quality of life.
Scientific title
A reminiscence therapy intervention using virtual reality to improve apathy of older adults in residential aged care.
Secondary ID [1] 299562 0
Nil known
Universal Trial Number (UTN)
U1111-1242-1090
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Apathy 314828 0
Cognitive Function 314839 0
Condition category
Condition code
Mental Health 313165 313165 0 0
Other mental health disorders
Neurological 313176 313176 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be allocated to one of three groups. A reminiscence therapy intervention using virtual reality; an active control using a laptop computer or physical items for reminiscence; and a passive control/no treatment group. Three residential aged care sites will be used, one for each group.
Participants in the virtual reality and active control groups will attend 5 sessions face to face conducted in allocated rooms for research on site at each residential aged care facility. Sessions will include, baseline, follow-up and 3 intervention sessions (over a period of 4 weeks). Participants in the passive control group will attend 2 sessions face to face, baseline and follow-up (over a period of 4 weeks).
Participants in all three groups will have activity levels measured for 2 days using an activity watch, this will occur prior to baseline measures and will be repeated after follow-up.

Session 1
For the virtual reality and active control groups only, the first session will include an interview to assess and identify appropriate reminiscence topics. This will include movies and television; music; holidays/travel; occupation; cultural; or gender specific themes. This will follow best practice reminiscence therapy guidelines (Westphal, A., Callega, D., LoGiudice, D., & Lautenschlager, N. 2017. Using reminiscence with people with dementia in sub-acute & acute care).
For all three groups, The Apathy Evaluation Scale, Geriatric Depression Scale, Cognitive measures, The Quality of Life in Alzheimer’s Disease QOL-AD and Three-Item Loneliness scale will be completed. This session will take approximately 2 hours for the virtual reality and active control groups and 1 hour for the passive control group.

Sessions 2-4 (virtual reality and active control only)
Participants will have physiological measures recorded during the session with a wristband. Sessions will also be audio-taped.
At the beginning of the session participants will be asked a question and requested to respond for a maximum of one minute. Participants will also be requested to read a wordless picture book for a maximum of five minutes. This will be repeated at the end of the session.
The virtual reality intervention will use a virtual reality headset. The active control will use computer screens/iPads and/or physical items (eg photos, magazines). Participants will view tailored content based on information from session 1, for example, where the participants grew up, school attended, places they have travelled and other places of interest specific to the participant. The duration of the intervention will be approximately 60 minutes. This will include 10 minutes set-up time, 15 minutes for speech tasks, 20 minutes of reminiscence intervention. In the virtual reality intervention 10 minutes will be needed for assessing sickness symptoms using the Simulator Sickness Questionnaire. These sessions will be conducted by the primary investigator, a PhD candidate.

Session 5 (all three groups)
Baseline measures taken in the first session will be repeated. This session will take approximately 1 hour.

Session 1 through to 5 will be completed within a period of approximately 10 working days.

Adherence to intervention will be monitored by the primary investigator by reminding participants the day before and on the morning of sessions face to face.
Intervention code [1] 315815 0
Prevention
Intervention code [2] 315885 0
Treatment: Other
Intervention code [3] 315886 0
Treatment: Devices
Comparator / control treatment
The traditional group (active control) will have reminiscence therapy delivered using physical items (eg photos, magazines) or computer screens/iPads.
A passive control (no treatment) group will also be included.
The Simulator Sickness Questionnaire will not be administered to these groups. For the active control, all other elements including duration of time and number of session remain the same as the virtual reality intervention group. The passive control (no treatment) will only undergo baseline and follow-up (no intervention).
Control group
Active

Outcomes
Primary outcome [1] 321694 0
Apathy measured by the Apathy Evaluation Scale
Timepoint [1] 321694 0
Baseline and post intervention. Post intervention time-point will be 1 day after the last intervention session.
Secondary outcome [1] 375919 0
Cognition measured by Addenbrooke's Cognitive Examination - III
Timepoint [1] 375919 0
Baseline and post intervention. Post intervention time-point will be 1 day after the last intervention session.
Secondary outcome [2] 375920 0
Depression measured using the Geriatric Depression Scale
Timepoint [2] 375920 0
Baseline and post intervention. Post intervention time-point will be 1 day after the last intervention session.
Secondary outcome [3] 375921 0
Quality of Life measured using the Quality of Life in Alzheimer's Disease (QOL-AD)
Timepoint [3] 375921 0
Baseline and post intervention. Post intervention time-point will be 1 day after the last intervention session.
Secondary outcome [4] 375933 0
Sickness symptoms from using virtual reality measured using Simulator Sickness Questionnaire
Timepoint [4] 375933 0
The Simulator Sickness Questionnaire will be administered 10 minutes before the virtual reality intervention and 10 minutes after the virtual reality session.
Secondary outcome [5] 375976 0
Quantity of spoken words from recording after viewing image. This will be be assessed by the researcher reviewing the recordings taken from a digital voice recorder.
Timepoint [5] 375976 0
The recordings will be taken immediately before the reminiscence session and immediately after the reminiscence session (for both virtual reality and active control groups).
Secondary outcome [6] 388959 0
Loneliness measured using the Three-item Loneliness Scale.
Timepoint [6] 388959 0
Baseline and post intervention. Post intervention time-point will be 1 day after the last intervention session.

Eligibility
Key inclusion criteria
Persons aged 65 years or older and residing in residential aged care, male or female and proficient English speakers. For those in the virtual reality condition, must be able to see clearly in the head-mounted display with or without the use of eyeglasses.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons that have learning disabilities.
Significant neurological disorders or psychotic disorders.
Those that have issues with confusion/disorientation or who may become distressed due to confusion re time and place.
Participants with agitation, aggression or other conditions at a level that will make assessment or cooperation with the intervention difficult.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size has been estimated based on limited studies previously completed in Residential Aged Care. SPSS will be used to analyse data. Repeated measures ANOVA will be the primary statistical analysis used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/11/2019
Actual
9/12/2019
Date of last participant enrolment
Anticipated
31/03/2021
Actual
29/01/2021
Date of last data collection
Anticipated
30/04/2021
Actual
26/02/2021
Sample size
Target
45
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 28255 0
5125 - Golden Grove
Recruitment postcode(s) [2] 28256 0
5095 - Mawson Lakes
Recruitment postcode(s) [3] 32012 0
5085 - Northgate

Funding & Sponsors
Funding source category [1] 304048 0
University
Name [1] 304048 0
University of South Australia
Country [1] 304048 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia
GPO Box 2471
Adelaide, South Australia 5001
Australia
Country
Australia
Secondary sponsor category [1] 304240 0
None
Name [1] 304240 0
Address [1] 304240 0
Country [1] 304240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304539 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 304539 0
Ethics committee country [1] 304539 0
Australia
Date submitted for ethics approval [1] 304539 0
14/08/2018
Approval date [1] 304539 0
28/09/2018
Ethics approval number [1] 304539 0
201474

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

Contacts
Principal investigator
Name 97314 0
Mr Dimitrios Saredakis
Address 97314 0
The University of South Australia
School of Psychology, Social Work and Social Policy
GPO Box 2471, Adelaide, South Australia 5001
Country 97314 0
Australia
Phone 97314 0
+61 08 8302 4083
Fax 97314 0
Email 97314 0
dimitrios.saredakis@mymail.unisa.edu.au
Contact person for public queries
Name 97315 0
Dimitrios Saredakis
Address 97315 0
The University of South Australia
School of Psychology, Social Work and Social Policy
GPO Box 2471, Adelaide, South Australia 5001
Country 97315 0
Australia
Phone 97315 0
+61 08 8302 4083
Fax 97315 0
Email 97315 0
dimitrios.saredakis@mymail.unisa.edu.au
Contact person for scientific queries
Name 97316 0
Tobias Loetscher
Address 97316 0
The University of South Australia
School of Psychology, Social Work and Social Policy
GPO Box 2471, Adelaide, South Australia 5001
Country 97316 0
Australia
Phone 97316 0
+61 08 8302 4098
Fax 97316 0
Email 97316 0
tobias.loetscher@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not included in ethics approval


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
SourceTitleYear of PublicationDOI
EmbaseVirtual reality intervention to improve apathy in residential aged care: Protocol for a multisite non-randomised controlled trial.2021https://dx.doi.org/10.1136/bmjopen-2020-046030
N.B. These documents automatically identified may not have been verified by the study sponsor.