Clinical trial NCT05867641: VR&R: Providing Caregiver Respite by Managing BPSDs and Improving QoL in People with Dementia Using Immersive VR-Therapy
Official title: VR&R: Providing Respite to Caregivers by Managing BPSDs and Improving QoL in People with Dementia Using Immersive VR-Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Keywords: Non-pharmacological
Caregiver Respite
Virtual Reality
Home Based Care
Quality of Life
Behavioral and psychological symptoms of dementia
Mood
Well-Being
Serious Game
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Centre for Aging and Brain Health Innovation
name: Ontario AHSC AFP Innovation Fund
name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pragmatic crossover interventional trial including a four-week home-based intervention (two weeks per condition) and two-week follow-up.
Primary purpose: TREATMENT

Brief summary: The goal of this interventional trial is to learn about how immersive Virtual Reality (VR) therapy can be used at home by individuals with dementia, with assistance from their informal (e.g., friend/family) caregivers.

The main question it aims to answer are:

1. Can caregivers receive quality respite time by using VR-therapy at home with their loved ones with dementia? Does this intervention reduce feelings of burden and improve well-being and resilience for caregivers?
2. Does VR-therapy help to manage behavioural and psychological symptoms (e.g., mood, apathy, agitation) and improve quality of life for individuals with dementia?
3. What types of VR "medium" (passive or cooperative) are most effective for achieving the above objectives?

Participant pairs will be asked to:

* Take part in an initial at-home VR technology training session and complete a series of brief questionnaires (e.g., health history/technology use, well-being/quality of life, symptoms of dementia)
* Use "VR\&R" (VR Rest \& Relaxation Therapy) for a period of 4 weeks (30 minute sessions, desired frequency), and answer a brief set of questions after each VR\&R session
* Provide feedback on the VR\&R intervention in semi-structured interview with the researcher and answer additional questionnaires at a 2-week follow-up

During VR\&R sessions, participants with dementia will have the opportunity to choose to watch (1) immersive 360-degree videos (e.g., of a live performance, or beach) on their own and (2) experience the same VR videos together with a researcher.

Caregivers will be asked to assist their loved one with dementia to use VR\&R by helping to put on the VR headset, selecting a VR experience through a user-friendly application, and remaining nearby to supervise and provide assistance as needed. During VR\&R sessions, caregivers may use this time to take a personal break or complete short tasks (e.g., make a cup of coffee, have an uninterrupted phone call).

Detailed description: Caregivers of individuals with dementia experience twice as much distress as those providing care for other seniors. This burden is particularly common when the person with dementia displays aggression. A number of recent studies have indicated that Virtual Reality (VR)-therapy is a safe, acceptable, and enjoyable non-pharmacological intervention for individuals with dementia, with potential to manage symptoms and promote quality of life. However, further research is needed to determine how to best design VR-therapy for this purpose. Moreover, it is not yet known whether VR is helpful for providing respite for caregivers. In this study, the investigators aim to determine whether "VR\&R", an immersive VR-therapy, is helpful for providing caregiver respite and managing symptoms of dementia (mood, apathy, agitation). Additionally, this study will explore what type of VR "medium" is most effective for achieving these outcomes. The VR\&R intervention includes a user-friendly web-application that caregivers can use to select among three different multi-sensory mediums for their loved one with dementia to experience (1) "Solo VR": 360-degree videos that simulate real-life environments (the ocean, watching a ballet) and (2) "Social VR": where a researcher interacts with the participants while using VR. Participants will use VR\&R at home for up to 30 minutes at a time, for four weeks. Outcomes will be evaluated using mixed methods (questionnaires, semi-structured interviews, observations, objective metrics of VR usage). The investigators predict that the intervention will provide caregivers with uninterrupted time to complete brief tasks that they may not have been able to otherwise, improving well-being and reducing feelings of burden. This study's findings will have implications for designing and implementing home-based VR interventions, including which types of VR experiences keep individuals with dementia engaged the longest, are easiest to use, and are seen as most beneficial by end-users.

Eligibility criteria: Inclusion Criteria: People with dementia

* Individuals who are 65 years of age or older
* Individuals living at home with a family caregiver
* Individuals diagnosed with dementia

Exclusion Criteria:

* Individuals with open wounds on face (sutured lacerations exempted)
* Individuals with a history of seizures or epilepsy
* Individuals with a pacemaker
* Individuals with head trauma or stroke leading to their current admission
* Individuals with cervical conditions or injuries that would make it unsafe for them to use the VR headset
* Individuals who identify as being legally blind
* Individuals with alcohol related dementia/ Korsakoff syndrome.
* Individuals who have a Public Guardian and Trustee (PGT) as Substitute Decision Maker (SDM)
* Individuals who cannot speak and understand English

Caregiver inclusion criteria:

* Individuals who identify as a primary caregiver for the PwD
* Individuals who have access to the internet through a device (computer, tablet, or mobile phone) that can be used during the study

Caregiver exclusion criteria:

* Individuals who cannot speak and understand English
* Individuals who are cognitively unable to provide informed consent for themselves
* Identify as legally blind

Primary outcomes:
measure: Change in Caregiver Respite and Burden
timeFrame: 6 Weeks
measure: Change in Caregiver Respite and Burden: Caregiver Phone Interview
timeFrame: 6 Weeks
measure: Change Caregiver Well-Being
timeFrame: 6 Weeks
measure: Change in Caregiver Respite and Burden: Post-Session Log
timeFrame: 4 Weeks
measure: Change in Caregiver Resilience
timeFrame: 6 Weeks
Secondary outcomes:
measure: Change in PwD Behavioural and Psychological Symptoms of Dementia: Neuropsychiatric Symptoms
timeFrame: 6 Weeks
measure: Immediate Impact of Intervention on PwD Mood
timeFrame: 4 Weeks
Other outcomes:
measure: Usability/Preference: System Usability Scale (SUS)
timeFrame: 6 Weeks
measure: Usability/Preference: Semi-Structured Interviews
timeFrame: 6 Weeks
measure: PwD Simulator Sickness
timeFrame: Baseline
measure: PwD Preferences/Reactions to VR: Post-Session Experience Ratings
timeFrame: 4 Weeks
measure: PwD Preferences/Reactions to VR: Post Session Log
timeFrame: 4 Weeks
measure: PwD Preferences/Reactions to VR: Time Spent in Each VR Medium
timeFrame: 4 Weeks
measure: PwD Preferences/Reactions to VR: Head Movements in VR
timeFrame: 4 Weeks
measure: Cognition (Participant with Dementia)
timeFrame: Baseline
measure: Gender Expression (Caregiver)
timeFrame: Baseline
Locations:
city: Oakville
country: Canada
facility: Acclaim Health
state: Ontario
city: Toronto
country: Canada
facility: Chester Village
state: Ontario
city: Toronto
country: Canada
facility: Circle of Care
state: Ontario
city: Toronto
country: Canada
facility: Toronto Grace Hospital - Main Site
state: Ontario
city: Toronto
country: Canada
facility: Toronto Grace Hospital - Remote Care Monitoring
state: Ontario
city: Toronto
country: Canada
facility: Toronto Grace Hospital - Specialized Care Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill Dementia Education Centre
state: Quebec
Study officials:
References:
citation: Anderson-Hanley C, Arciero PJ, Brickman AM, Nimon JP, Okuma N, Westen SC, Merz ME, Pence BD, Woods JA, Kramer AF, Zimmerman EA. Exergaming and older adult cognition: a cluster randomized clinical trial. Am J Prev Med. 2012 Feb;42(2):109-19. doi: 10.1016/j.amepre.2011.10.016.
citation: Appel L, Appel E, Bogler O, Wiseman M, Cohen L, Ein N, Abrams HB, Campos JL. Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. Front Med (Lausanne). 2020 Jan 15;6:329. doi: 10.3389/fmed.2019.00329. eCollection 2019.
citation: Appel L, Kisonas E, Appel E, Klein J, Bartlett D, Rosenberg J, Smith C. Introducing virtual reality therapy for inpatients with dementia admitted to an acute care hospital: learnings from a pilot to pave the way to a randomized controlled trial. Pilot Feasibility Stud. 2020 Oct 31;6(1):166. doi: 10.1186/s40814-020-00708-9.
citation: Appel L, Kisonas E, Appel E, Klein J, Bartlett D, Rosenberg J, Smith CN. Administering Virtual Reality Therapy to Manage Behavioral and Psychological Symptoms in Patients With Dementia Admitted to an Acute Care Hospital: Results of a Pilot Study. JMIR Form Res. 2021 Feb 3;5(2):e22406. doi: 10.2196/22406.
citation: Appel L, Ali S, Narag T, Mozeson K, Pasat Z, Orchanian-Cheff A, Campos JL. Virtual reality to promote wellbeing in persons with dementia: A scoping review. J Rehabil Assist Technol Eng. 2021 Dec 21;8:20556683211053952. doi: 10.1177/20556683211053952. eCollection 2021 Jan-Dec.
citation: Baker JR, Webster L, Lynn N, Rogers J, Belcher J. Intergenerational Programs May Be Especially Engaging for Aged Care Residents With Cognitive Impairment: Findings From the Avondale Intergenerational Design Challenge. Am J Alzheimers Dis Other Demen. 2017 Jun;32(4):213-221. doi: 10.1177/1533317517703477.
citation: D'Cunha NM, Nguyen D, Naumovski N, McKune AJ, Kellett J, Georgousopoulou EN, Frost J, Isbel S. A Mini-Review of Virtual Reality-Based Interventions to Promote Well-Being for People Living with Dementia and Mild Cognitive Impairment. Gerontology. 2019;65(4):430-440. doi: 10.1159/000500040. Epub 2019 May 20.
citation: Dermody G, Whitehead L, Wilson G, Glass C. The Role of Virtual Reality in Improving Health Outcomes for Community-Dwelling Older Adults: Systematic Review. J Med Internet Res. 2020 Jun 1;22(6):e17331. doi: 10.2196/17331.
citation: Huygelier H, Schraepen B, van Ee R, Vanden Abeele V, Gillebert CR. Acceptance of immersive head-mounted virtual reality in older adults. Sci Rep. 2019 Mar 14;9(1):4519. doi: 10.1038/s41598-019-41200-6.
citation: Munoz J, Mehrabi S, Li Y, Basharat A, Middleton LE, Cao S, Barnett-Cowan M, Boger J. Immersive Virtual Reality Exergames for Persons Living With Dementia: User-Centered Design Study as a Multistakeholder Team During the COVID-19 Pandemic. JMIR Serious Games. 2022 Jan 19;10(1):e29987. doi: 10.2196/29987.