DementiaVR&RNCT05867641
VR&R: Providing Caregiver Respite by Managing BPSDs and Improving QoL in People with Dementia Using Immersive VR-Therapy
A study testing Immersive VR Therapy in Head-Mounted Display (HMD) (Solo) and Immersive VR Therapy in a Head-Mounted Display (HMD) (Social) in people with Dementia, run by University Health Network, Toronto at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Immersive VR Therapy in Head-Mounted Display (HMD) (Solo) and Immersive VR Therapy in a Head-Mounted Display (HMD) (Social)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesCanada
- Study dates
- 12 Feb 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals who are 65 years of age or older
- Individuals living at home with a family caregiver
- Individuals diagnosed with dementia
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lora Appel, PhD contact
7 sites in 1 country
Canada7 sites, 6 recruiting
- Not yet recruiting
McGill Dementia Education Centre
Montreal, Quebec, H3G 2M1
Diane Weidner, diane.weidner@mcgill.ca
- Recruiting
Acclaim Health
Oakville, Ontario, L6L 5M2
Patricia Blakely, pblakeley@acclaimhealth.ca, pblakeley@acclaimhealth.ca
- Recruiting
Chester Village
Toronto, Ontario, M1L 1E3
Cynthia Marianelli, 416-466-2173, cynthia@chestervillage.ca
- Recruiting
Circle of Care
Toronto, Ontario, M2P 2A9
Lisa Rae, 416-635-2860 ext. 284, lrae@circleofcare.com
- Active, not recruiting
Toronto Grace Hospital - Main Site
Toronto, Ontario, M4Y 2G5
- Recruiting
Toronto Grace Hospital - Remote Care Monitoring
Toronto, Ontario, M4Y 2G5
Danielle Lechman, 437-233-2661, dkilby-Lechman@torontograce.org
- Recruiting
Toronto Grace Hospital - Specialized Care Centre
Toronto, Ontario, M4Y 2G5
Chrincia Bernard, 647-670-2611 ext. 201, cbernard@torontograce.org
About this study
Official title: VR&R: Providing Respite to Caregivers by Managing BPSDs and Improving QoL in People with Dementia Using Immersive VR-Therapy
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:
Read more
- 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?
- Does VR-therapy help to manage behavioural and psychological symptoms (e.g., mood, apathy, agitation) and improve quality of life for individuals with dementia?
- 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).
Read the 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.
- Conditions
- Dementia
- Being tested
- Immersive VR Therapy in Head-Mounted Display (HMD) (Solo), Immersive VR Therapy in a Head-Mounted Display (HMD) (Social)
- Keywords
- Non-pharmacological, Caregiver Respite, Virtual Reality, Home Based Care, Quality of Life, Behavioral and psychological symptoms of dementia, Mood, Well-Being, Serious Game
- Medical subject headings
- Dementia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive VR Therapy in Head-Mounted Display (HMD) (Solo)Behavioural
Also called Solo VR Therapy
Caregivers will be trained to administer VR\&R therapy to their loved ones with dementia, in their private home/residence. Participants with dementia will view immersive VR experiences using a commercially-available VR head-mounted device for up to 30 minutes a time, approximately every other day (or as desired), for two weeks. The caregiver will use the custom application on a tablet to select and monitor what their loved one sees in VR.
Staying nearby to monitor for safety and assistance, the caregiver may choose to use the time when their loved one is engaged to take some respite time for themselves (e.g., make a cup of coffee, have an uninterrupted phone call).
Immersive VR Therapy in a Head-Mounted Display (HMD) (Social)Behavioural
Also called Social VR Therapy
Participants with dementia will view immersive VR experiences using a commercially-available VR head-mounted device for up to 30 minutes a time, 2 to 3 times per week, for 2 weeks. A research assistant who is trained in dementia care will use the custom application on a tablet to select and monitor what their loved one sees in VR.
Staying nearby to monitor for safety and assistance, the caregiver may choose to use the time when their loved one is engaged to take some respite time for themselves (e.g., make a cup of coffee, have an uninterrupted phone call).
| Study group | Role | What they receive |
|---|---|---|
| VR&R Therapy - Solo First | Experimental | Recruited dyads will include one person diagnosed with dementia and their caregiver (e.g., family/friend). The caregiver will assist their loved ones with dementia to use VR-therapy at home. Caregivers may use the time while their loved ones are engaged for respite, remaining nearby to supervise and assist.
For the first two weeks, only the caregiver will be present to use VR with the person with dementia. For the following two weeks, a research assistant will be present to use VR with the person with dementia. Receives: Behavioral: Immersive VR Therapy in Head-Mounted Display (HMD) (Solo); Behavioral: Immersive VR Therapy in a Head-Mounted Display (HMD) (Social) |
| VR&R Therapy - Social First | Experimental | Recruited dyads will include one person diagnosed with dementia and their caregiver (e.g., family/friend). The caregiver will assist their loved ones with dementia to use VR-therapy at home. Caregivers may use the time while their loved ones are engaged for respite, remaining nearby to supervise and assist.
For the first two weeks, a research assistant will be present to use VR with the person with dementia. For the following two weeks, only the caregiver will be present. Receives: Behavioral: Immersive VR Therapy in Head-Mounted Display (HMD) (Solo); Behavioral: Immersive VR Therapy in a Head-Mounted Display (HMD) (Social) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caregiver Respite and Burden
Unpaid Caregivers: Short Zarit Burden Interview The Short Zarit Burden Interview tool will be completed by caregiver-participants and will be used to evaluate subjective feelings of caregiver burden associated with being a caregiver for the person with dementia. The Short Zarit Burden Interview is a 6-item questionnaire that employs a 5-point Likert scale. Total scores range from 0-24 where higher scores indicate greater feelings of caregiver burden.
Paid Caregivers: Professional Care Team Burden Scale The 10-item Professional Care Team Burden (PCTB) Scale is a validated tool designed to assess the burden experienced by professional caregivers working in dementia care settings such as nursing homes. It evaluates three dimensions of burden: subjective burden (individual emotional strain), organizational burden (workplace factors), and structural burden (systemic or institutional challenges).
Measured: 6 Weeks
Change in Caregiver Respite and Burden: Caregiver Phone Interview
The caregiver will be asked to take part in a pre- and post- intervention phone interview (approximately 15 minutes in length, audio-recorded). The interview will include open-ended questions to gather qualitative information on the impact of the VR intervention on the caregiver and PwD (i.e., whether there were any changes to baseline PwD \& caregiver well-being/QoL, BPSD, caregiver burden, and caregiver respite following the intervention), as well as feedback on the VR mediums in terms of their ability to promote caregiver respite.
Measured: 6 Weeks
Change Caregiver Well-Being
WHO-5 Well-Being Index will be administered to caregiver-participants to evaluate subjective wellbeing. The WHO (Five) is a 5-item questionnaire employing 6-point Likert scales. Calculated scores range from 0-25. A score of 0 represents the worst possible and a score of 25 represents the best possible quality of life. A score below 13 represents poor wellbeing. A change of 10% represents a significant change in wellbeing.
Measured: 6 Weeks
Change in Caregiver Respite and Burden: Post-Session Log
Caregivers will be asked to describe their time while the PwD was using VR in a paper-based log. This tool aims to capture if the caregiver was able to obtain additional respite, and the degree to which they were able to obtain respite (i.e., the degree to which caregivers were able to remain vigilant and at the same time detach and focus on their own task). Caregivers will also have the opportunity to record observations of the PwD's reactions to/experience with the VR intervention, as well as additional feedback and reflections of their own or from discussion with the PwD.
Measured: 4 Weeks
Change in Caregiver Resilience
The 10-item Connor-Davidson Resilience Scale (CD-RISC) is a condensed version of the original 25-item scale, designed to efficiently measure resilience, the ability to adapt and thrive in the face of adversity. Each of its 10 items is rated on a 5-point Likert scale, with higher scores indicating greater resilience. The scale emphasizes key resilience traits such as adaptability, persistence, and emotional regulation. Validated across diverse populations, it has shown strong reliability, internal consistency, and construct validity. Its brevity and ease of use make it a valuable tool for both research and clinical settings, especially when time is limited.
Measured: 6 Weeks
Secondary outcomes (2)
Change in PwD Behavioural and Psychological Symptoms of Dementia: Neuropsychiatric Symptoms
The Neuropsychiatric Inventory-Questionnaire (NPI-Q) will be completed by the caregiver. The NPI-Q is a 12-item questionnaire that measures neuropsychiatric symptoms (e.g., related to related to mood, behavioural disturbance) as well as caregiver distress corresponding to reported symptoms.
Measured: 6 Weeks
Immediate Impact of Intervention on PwD Mood
Participants with dementia will be prompted to select from a set of eight faces displaying different emotions, immediately before and after each VR-therapy session. These include positive emotions (happy, joyful, relaxed) and negative emotions (anxious, sad, angry, confused, indifferent). These metrics will be collected before and after each intervention session (i.e., at a time-interval of approximately 30 minutes, depending on session length.)
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start12 Feb 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Pragmatic crossover interventional trial including a four-week home-based intervention (two weeks per condition) and two-week follow-up.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation, Ontario AHSC AFP Innovation Fund, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Lora Appel, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867641
- Sponsor's protocol ID
- VR&R
- Acronym
- VR&R
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22261206Appel 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.
PubMed 32010701Appel 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.
PubMed 33292729Appel 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.
PubMed 33533720Appel 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.
PubMed 35024166Baker 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.
PubMed 28506126D'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.
PubMed 31108489Dermody 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.
PubMed 32478662Huygelier 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.
PubMed 30872760Munoz 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.
PubMed 35044320
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR&R: Providing Respite to Caregivers by Managing BPSDs and Improving QoL in People with Dementia Using Immersive VR-Therapy
- ClinicalTrials.gov ID
- NCT05867641
- Acronym / sponsor ID
- VR&R / VR&R
- Conditions
- Dementia
- Keywords
- Non-pharmacological, Caregiver Respite, Virtual Reality, Home Based Care, Quality of Life, Behavioral and psychological symptoms of dementia, Mood, Well-Being
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation, Ontario AHSC AFP Innovation Fund, Canadian Institutes of Health Research (CIHR)
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Does VR-therapy help to manage behavioural and psychological symptoms (e.g., mood, apathy, agitation) and improve quality of life for individuals with dementia?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic crossover interventional trial including a four-week home-based intervention (two weeks per condition) and two-week follow-up.
| Arm | Type | Receives |
|---|---|---|
| VR&R Therapy - Solo First | Experimental | Behavioral: Immersive VR Therapy in Head-Mounted Display (HMD) (Solo), Behavioral: Immersive VR Therapy in a Head-Mounted Display (HMD) (Social)Recruited dyads will include one person diagnosed with dementia and their caregiver (e.g., family/friend). The caregiver will assist their loved ones with dementia to use VR-therapy at home. Caregivers may use the time while their loved ones are engaged for respite, remaining nearby to supervise and assist. For the first two weeks, only the caregiver will be present to use VR with the person with dementia. For the following two weeks, a research assistant will be present to use VR with the person with dementia. |
| VR&R Therapy - Social First | Experimental | Behavioral: Immersive VR Therapy in Head-Mounted Display (HMD) (Solo), Behavioral: Immersive VR Therapy in a Head-Mounted Display (HMD) (Social)Recruited dyads will include one person diagnosed with dementia and their caregiver (e.g., family/friend). The caregiver will assist their loved ones with dementia to use VR-therapy at home. Caregivers may use the time while their loved ones are engaged for respite, remaining nearby to supervise and assist. For the first two weeks, a research assistant will be present to use VR with the person with dementia. For the following two weeks, only the caregiver will be present. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Individuals who are 65 years of age or older
- Individuals living at home with a family caregiver
- Individuals diagnosed with dementia
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive VR Therapy in Head-Mounted Display (HMD) (Solo)Also: Solo VR TherapyCaregivers will be trained to administer VR\&R therapy to their loved ones with dementia, in their private home/residence. Participants with dementia will view immersive VR experiences using a commercially-available VR head-mounted device for up to 30 minutes a time, approximately every other day (or as desired), for two weeks. The caregiver will use the custom application on a tablet to select and monitor what their loved one sees in VR. Staying nearby to monitor for safety and assistance, the caregiver may choose to use the time when their loved one is engaged to take some respite time for themselves (e.g., make a cup of coffee, have an uninterrupted phone call). | Behavioural | VR&R Therapy - Social First, VR&R Therapy - Solo First |
| Immersive VR Therapy in a Head-Mounted Display (HMD) (Social)Also: Social VR TherapyParticipants with dementia will view immersive VR experiences using a commercially-available VR head-mounted device for up to 30 minutes a time, 2 to 3 times per week, for 2 weeks. A research assistant who is trained in dementia care will use the custom application on a tablet to select and monitor what their loved one sees in VR. Staying nearby to monitor for safety and assistance, the caregiver may choose to use the time when their loved one is engaged to take some respite time for themselves (e.g., make a cup of coffee, have an uninterrupted phone call). | Behavioural | VR&R Therapy - Social First, VR&R Therapy - Solo First |
Primary outcome
Change in Caregiver Respite and Burden
Time frame: 6 Weeks
Unpaid Caregivers: Short Zarit Burden Interview The Short Zarit Burden Interview tool will be completed by caregiver-participants and will be used to evaluate subjective feelings of caregiver burden associated with being a caregiver for the person with dementia. The Short Zarit Burden Interview is a 6-item questionnaire that employs a 5-point Likert scale. Total scores range from 0-24 where higher scores indicate greater feelings of caregiver burden. Paid Caregivers: Professional Care Team Burden Scale The 10-item Professional Care Team Burden (PCTB) Scale is a validated tool designed to assess the burden experienced by professional caregivers working in dementia care settings such as nursing homes. It evaluates three dimensions of burden: subjective burden (individual emotional strain), organizational burden (workplace factors), and structural burden (systemic or institutional challenges).
Change in Caregiver Respite and Burden: Caregiver Phone Interview
Time frame: 6 Weeks
The caregiver will be asked to take part in a pre- and post- intervention phone interview (approximately 15 minutes in length, audio-recorded). The interview will include open-ended questions to gather qualitative information on the impact of the VR intervention on the caregiver and PwD (i.e., whether there were any changes to baseline PwD \& caregiver well-being/QoL, BPSD, caregiver burden, and caregiver respite following the intervention), as well as feedback on the VR mediums in terms of their ability to promote caregiver respite.
Change Caregiver Well-Being
Time frame: 6 Weeks
WHO-5 Well-Being Index will be administered to caregiver-participants to evaluate subjective wellbeing. The WHO (Five) is a 5-item questionnaire employing 6-point Likert scales. Calculated scores range from 0-25. A score of 0 represents the worst possible and a score of 25 represents the best possible quality of life. A score below 13 represents poor wellbeing. A change of 10% represents a significant change in wellbeing.
Change in Caregiver Respite and Burden: Post-Session Log
Time frame: 4 Weeks
Caregivers will be asked to describe their time while the PwD was using VR in a paper-based log. This tool aims to capture if the caregiver was able to obtain additional respite, and the degree to which they were able to obtain respite (i.e., the degree to which caregivers were able to remain vigilant and at the same time detach and focus on their own task). Caregivers will also have the opportunity to record observations of the PwD's reactions to/experience with the VR intervention, as well as additional feedback and reflections of their own or from discussion with the PwD.
Change in Caregiver Resilience
Time frame: 6 Weeks
The 10-item Connor-Davidson Resilience Scale (CD-RISC) is a condensed version of the original 25-item scale, designed to efficiently measure resilience, the ability to adapt and thrive in the face of adversity. Each of its 10 items is rated on a 5-point Likert scale, with higher scores indicating greater resilience. The scale emphasizes key resilience traits such as adaptability, persistence, and emotional regulation. Validated across diverse populations, it has shown strong reliability, internal consistency, and construct validity. Its brevity and ease of use make it a valuable tool for both research and clinical settings, especially when time is limited.
2 secondary outcomes
Change in PwD Behavioural and Psychological Symptoms of Dementia: Neuropsychiatric Symptoms
Time frame: 6 Weeks
Immediate Impact of Intervention on PwD Mood
Time frame: 4 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 22261206Anderson-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.
- Background: PubMed 32010701Appel 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.
- Background: PubMed 33292729Appel 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.
- Background: PubMed 33533720Appel 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.
- Background: PubMed 35024166Appel 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.
- Background: PubMed 28506126Baker 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.
- Background: PubMed 31108489D'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.
- Background: PubMed 32478662Dermody 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.
- Background: PubMed 30872760Huygelier 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.
- Background: PubMed 35044320Munoz 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.
- VR\&R Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lora Appel, PhD contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive VR Therapy in Head-Mounted Display (HMD) (Solo) and Immersive VR Therapy in a Head-Mounted Display (HMD) (Social) in people with Dementia, run by University Health Network, Toronto at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lora Appel, PhD (6475046537, lora.appel@yorku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Caregiver Respite and Burden (time frame: 6 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05867641, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.