Dementia
Conditions
Keywords
Non-pharmacological, Caregiver Respite, Virtual Reality, Home Based Care, Quality of Life, Behavioral and psychological symptoms of dementia, Mood, Well-Being, Serious Game
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.
Interventions
BEHAVIORALImmersive VR Therapy in Head-Mounted Display (HMD) (Solo)
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).
BEHAVIORALImmersive VR Therapy in a Head-Mounted Display (HMD) (Social)
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).
Sponsors
Centre for Aging and Brain Health Innovation
Ontario AHSC AFP Innovation Fund
Canadian Institutes of Health Research (CIHR)
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pragmatic crossover interventional trial including a four-week home-based intervention (two weeks per condition) and two-week follow-up.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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.) |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cognition (Participant with Dementia) | Baseline | The Mini Mental State Exam (MMSE) will be administered to the PwD at baseline. This is a widely used cognitive screening test consisting of 12 questions administered orally. Scores range from 0-30, with scores of 0-9 suggesting severe cognitive impairment/late stage dementia, scores of 10-19 suggesting moderate cognitive impairment/middle stage dementia, scores of 20-25 suggesting mild cognitive impairment/early stage dementia, and scores of 26-30 suggesting possibly normal cognition. |
| Usability/Preference: System Usability Scale (SUS) | 6 Weeks | The System Usability Scale (SUS) will be completed by the caregiver to evaluate device usability/ease-of-use of the VR intervention (head-mounted device and VR&R application) used during the study. The SUS is a 10-item questionnaire employing 5-point Likert scales. Calculated scores range from 0-100. Higher scores indicate better system usability. |
| Gender Expression (Caregiver) | Baseline | A short form of the Personality Attributes Questionnaire with 8 items (PAQ-8) used to assess femininity and masculinity, which has been found to be a valid screening measure to assess gender expression. Scores on each scale are range from 0-32. On the masculine and masculine-feminine subscales, higher scores indicate a greater level of masculinity. On the feminine subscale, a higher score indicates a greater level of femininity. |
| Usability/Preference: Semi-Structured Interviews | 6 Weeks | The caregiver will take part in a semi-structured interview post-intervention. The interview will include open-ended questions to explore the acceptability and usability the 2 different VR-mediums, including suggestions for improvement. |
| PwD Simulator Sickness | Baseline | During the initial home training (pre-intervention), the researcher will observe the participant's reactions to a brief neutral VR video (a nature scene). The researcher will then administer the Fast Motion Sickness Scale (FMS). The scale asks the participant to rate any feelings of motion sickness on a scale of 0 to 20 where 0 indicates no motion sickness and 20 indicates a great deal of motion sickness (on the brink of vomiting). Participants with a score of 15 or higher will be withdrawn from the study. |
| PwD Preferences/Reactions to VR: Post-Session Experience Ratings | 4 Weeks | Immediately after each session, participants with dementia will be prompted to rate their experience on a visual analog Star scale (range of 1 to 5), where 1 indicates the worst possible experience and 5 indicates the best possible experience. |
| PwD Preferences/Reactions to VR: Post Session Log | 4 Weeks | Caregivers will be asked to record any observations and feedback related to their their loved one's reactions to VR (e.g., enjoyment, relaxation, engagement, anxiety/apprehension; what did/did not go well). Caregivers will be asked to make these recordings immediately after intervention sessions. |
| PwD Preferences/Reactions to VR: Time Spent in Each VR Medium | 4 Weeks | This objective metrics of VR usage will be will be unobtrusively collected through the VR&R application for the duration of the study. |
| PwD Preferences/Reactions to VR: Head Movements in VR | 4 Weeks | This objective metrics of VR usage will be will be unobtrusively collected through the VR&R application for the duration of the study. |
Countries
Canada
Contacts
Primary ContactLora Appel, PhD
Backup ContactLora Appel, PhD
Outcome results
None listed