VR&R: Providing Caregiver Respite by Managing BPSDs and Improving QoL in People with Dementia Using Immersive VR-Therapy
- Conditions
- Dementia
- Interventions
- Behavioral: Immersive VR Therapy in Head-Mounted Device (HMD)
- Registration Number
- NCT05867641
- Lead Sponsor
- University Health Network, Toronto
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
People with dementia
- Individuals who are 65 years of age or older
- Individuals living at home with a family caregiver
- Individuals diagnosed with dementia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description VR&R Therapy Immersive VR Therapy in Head-Mounted Device (HMD) Recruited dyads will include one person diagnosed with dementia and their informal caregiver (i.e., 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.
- Primary Outcome Measures
Name Time Method Change in Caregiver Respite and Burden 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Change in PwD Behavioural and Psychological Symptoms of Dementia: Neuropsychiatric Symptoms 6 Weeks 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.
Immediate Impact of Intervention on PwD Mood 4 Weeks 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.)
Trial Locations
- Locations (7)
Toronto Grace Hospital - Main Site
🇨🇦Toronto, Ontario, Canada
Toronto Grace Hospital - Remote Care Monitoring
🇨🇦Toronto, Ontario, Canada
Toronto Grace Hospital - Specialized Care Centre
🇨🇦Toronto, Ontario, Canada
McGill Dementia Education Centre
🇨🇦Montreal, Quebec, Canada
Acclaim Health
🇨🇦Oakville, Ontario, Canada
Chester Village
🇨🇦Toronto, Ontario, Canada
Circle of Care
🇨🇦Toronto, Ontario, Canada