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Trial registered on ANZCTR


Registration number
ACTRN12618000749202
Ethics application status
Approved
Date submitted
1/05/2018
Date registered
4/05/2018
Date last updated
4/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Reality in residential aged care
Scientific title
Virtual Reality for Residential Aged Care - effects on engagement, mood states, anxiety, agitation and psychotropic medication use: a feasibility controlled trial
Secondary ID [1] 293148 0
N/A
Universal Trial Number (UTN)
Trial acronym
VRRAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 305124 0
Behavioural and psychological symptoms of dementia (BPSD) 305125 0
Psychotropic prescribing 305126 0
Anxiety 307655 0
Condition category
Condition code
Mental Health 304443 304443 0 0
Anxiety
Neurological 306741 306741 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design: This feasibility study will run VR experiences as a small group session (n=5 per group) over four weeks, with residents receiving 2x sessions per week (total of 8 sessions). The VR sessions will be implemented at a large RAC home with four separate communities using convenience sampling. Three of the four communities will be used as intervention sites (total N=30) and one community as a control site (N=20). Residents will be excluded based on poor health status, severe vision impairment, and severely impaired verbal capabilities.

Intervention: The VR intervention will take place in an area with minimal competing stimulation (sound, traffic, activity, and other residents). The intervention will be conducted in the dining room or activity room in groups of five. Trained clinical facilitators will guide and oversee VR sessions at the intervention site. They will be onsite three times per week to administer the VR intervention to consenting participants. All sessions will be video and audio recorded.

Control group: The control group will participate in a small facilitated group activity (n=5 per group), with the VR experience supplemented for a group discussion on unrelated printed images. Sessions will mirror the VR intervention group, with sessions conducted twice per week for four weeks.

Session length: 30 minutes (10 minutes pre-intervention observation, 5 minutes VR/control experience, 10 minutes post intervention observation, and 5 minutes debriefing, assessment, documentation).

Technology : Samsung Galaxy S7 with VR headset.
Videos will be selected from applications: Arscape, Nomads, Expeditions and Relax VR, under the guidance of an occupational therapist and registered nurses at the participating site. Scenes will be selected without fast movement or rapid changes in perspective.

Consent: Written consent will be obtained from participants that are determined to have a psychogeriatric assessment scale (PAS) of four or under (indicating no or minimal cognitive impairment). For residents with a PAS above four, substituted written consent will be obtained from their legal guardians. Assent before each VR session will be obtained from each resident

Ethics : Human Research Ethics approval has been given by UnitingCare Queensland Human Research Ethics Committee, approval no. Brimelow 21417, and The University of Queensland Human Research Ethics Committee, approval no. 2018000746

Outcomes: This study will provide the first evidence to date of the feasibility of immersive VR in RAC as a group activity to provide pleasure, stimulus, and to improve mental health. This trial will help to determine for which residents VR is most beneficial and appropriate, with intentions for the participating site to adopt the technology into its leisure and lifestyle program based on the findings.
Evaluative measures

Neuropsychiatric symptoms:
Cornell Scale for Depression in dementia (CSD) – an assessment for depressive symptoms conducted by an observer in collaboration with the resident/carer. It contains 19 items scored on a three point scale; absent, mild/intermittent or severe, relating to symptoms experienced over the preceding week.- completed baseline (week 1) and post (week 6)

Cohen Mansfield Agitation Inventory (CMAI) Short (Cohen-Mansfield, 1997) – a 29 item observer rated questionnaire that measures physical and verbal aggressive and non-aggressive behaviours observed in the previous two weeks. Completed baseline (week 1), mid intervention (week 3) and post (week 6)

Geriatric Anxiety Index (GAI) (Pachana et al., 2007) – a 20 item self report questionnaire, rated as either agree or disagree that measures resident’s anxiety over the preceding week. Completed baseline (week 1), mid intervention (week 3) and post (week 6).

Emotional response:
Observed Emotions Rating Scale (OERS) (Van Haitsma and Klapper, 1999) - to measure resident’s emotional response the tool quantifies five observed emotions over a 10 minute period; pleasure, anger, anxiety/fear, sadness and general alertness (1 = never; 2 = <16 seconds; 3 = 16–59 seconds; 4 = 1–5 min; 5 = >5 min; and 7 = not in view). Completed before and after every VR /control session.

The Person–Environment Apathy Rating (PEAR) apathy subscale (Jao et al., 2016) – measures apathy by observing six indicators; facial expressions, eye contact, physical engagement, purposeful activity, verbal tone, and verbal expression, on a 1–4 scale. Completed before and after every VR /control session.

Smileometer (Read et al., 2002) – a self-reported scale of mood at that moment in time using. It is based on a 5-point Likert scale and uses five faces representing different levels of emotion from awful to brilliant. Completed before and after every VR /control session.

Engagement:
Resident feedback questionnaire. Completed after every VR /control session.
Social interactions during group sessions (video recorded)

Psychotropic medications:
Review of psychotropic medication use over the previous month (pre and post). Completed at baseline (week 1) and post (week 6).


Intervention code [1] 301058 0
Treatment: Other
Intervention code [2] 301059 0
Behaviour
Comparator / control treatment
Control group: The control group will participate in a small facilitated group activity (n=5 per group), with the VR experience supplemented for a group discussion on unrelated printed images. Sessions will mirror the VR intervention group, with sessions conducted twice per week for four weeks.

Session length: 30 minutes (10 minutes pre-intervention observation, 5 minutes VR/control experience, 10 minutes post intervention observation, and 5 minutes debriefing, assessment, documentation).
Control group
Active

Outcomes
Primary outcome [1] 305720 0
VR effects on depressive sympoms in aged care, as measured by the Cornell Scale for Depression.
Timepoint [1] 305720 0
Baseline (week 1), mid intervention period (week 3) and post intervention (week 6- primary endpoint).
Primary outcome [2] 305761 0
VR effects on agitation in aged care, as measured by Cohen-Mansfield Agitation Index
Timepoint [2] 305761 0
Baseline (week 1), mid intervention period (week 3) and post intervention (week 6- primary endpoint).
Primary outcome [3] 305762 0
VR effects on anxiety in aged care, as measured by Geriatric Anxiety Index
Timepoint [3] 305762 0
Baseline (week 1), mid intervention period (week 3) and post intervention (week 6- primary endpoint).
Secondary outcome [1] 346247 0
Composite secondary outcome: Immediate emtional response, as measured bythe smileometre, observed emotion rating scale and person apathy index.
Timepoint [1] 346247 0
Intervention period (week 2 to week 5). before and after every session (two sessions per week)
Secondary outcome [2] 346364 0
VR effects on pro re nata psychotropic prescribing, as determined by medication chart reviews.
Timepoint [2] 346364 0
Baseline (week 1),and post intervention (week 6)

Eligibility
Key inclusion criteria
Residents in a designated Residential Aged Care Facility. The facility has a collaborative agreement in place. Residents for whom we can obtain consent from either themesleves (in cases of minimal cogntive imapirment) or their substitue decsion makers in cases of moderate to severe cognitive imapirment are eligible.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents will be excluded based on poor health status, severe vision impairment, and severely impaired verbal capabilities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not conealed.
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
The VR sessions will be implemented at a large RAC home with four separate communities using convenience sampling. Three of the four communities will be used as intervention sites and one community as a control site. Residents in each community are in constant contact with each other, therefore if residents from the same community were divided into control and intervention the effects of the intervention could alter the control recipients experience.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a feasability study. 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 and regression modelling will be the primary statistical analysis used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22563 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 297774 0
Charities/Societies/Foundations
Name [1] 297774 0
Wesley Mission Queensland
Address [1] 297774 0
930 Gympie Road, Chermside, QLD 4320.
Country [1] 297774 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
UQ Centre for Clinical Research, Building 71/918 Royal Brisbane & Woman’s Hospital, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 298641 0
None
Name [1] 298641 0
Address [1] 298641 0
Country [1] 298641 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298835 0
UnitingCare Queensland Human Research Ethics Committee
Ethics committee address [1] 298835 0
Level 5, 192 Ann Street, Brisbane QLD 4001
Ethics committee country [1] 298835 0
Australia
Date submitted for ethics approval [1] 298835 0
Approval date [1] 298835 0
05/02/2018
Ethics approval number [1] 298835 0
Brimelow 21417
Ethics committee name [2] 300268 0
University of Queensland Human Research Ethics Office
Ethics committee address [2] 300268 0
Cumbrae-Stewart Building 72, The University of Queensland, St Lucia QLD 4072
Ethics committee country [2] 300268 0
Australia
Date submitted for ethics approval [2] 300268 0
Approval date [2] 300268 0
13/04/2018
Ethics approval number [2] 300268 0
2018000746

Summary
Brief summary
This controlled trial aims to determine the feasibility of virtual reality as a non-pharmacological approach to improve mood states within Residential Aged Care. Specifically, we aim to determine the effects of virtual reality on:
• Mood as measured through the use of observer and participant ratings of emotional response, apathy, and group engagement
• Agitation, anxiety, and depression levels
• Psychotropic prescribing and the administration of pro re nata (PRN) medications

We hypothesize that group based VR sessions will increase resident engagement and social interactions, reduce agitation, anxiety and apathy, and improve mental wellbeing.

Based on the finding of the pilot study we have conducted we anticipate results that have the potential to change the landscape of leisure and lifestyle activities conducted in RAC homes, and to supplement our current knowledge of non-pharmacological approaches for RAC resident mental wellbeing.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 78386 0
Dr Nadeeka Dissanayaka
Address 78386 0
UQ Centre for Clinical Research, Building 71/918 Royal Brisbane & Woman’s Hospital, Herston Australia, QLD 4029
Country 78386 0
Australia
Phone 78386 0
+61405715622
Fax 78386 0
Email 78386 0
n.dissanayaka@uq.edu.au
Contact person for public queries
Name 78387 0
Ms Rachel Brimelow
Address 78387 0
UQ Centre for Clinical Research, Building 71/918 Royal Brisbane & Woman’s Hospital, Herston , Australia, QLD 4029
Country 78387 0
Australia
Phone 78387 0
+61419627382
Fax 78387 0
Email 78387 0
r.brimelow@wmq.org.au
Contact person for scientific queries
Name 78388 0
Ms Rachel Brimelow
Address 78388 0
UQ Centre for Clinical Research, Building 71/918 Royal Brisbane & Woman’s Hospital, Herston Australia, QLD 4029
Country 78388 0
Australia
Phone 78388 0
+61419627382
Fax 78388 0
Email 78388 0
r.brimelow@wmq.org.au

No data has been provided for results reporting
Summary results
Not applicable