VR&R: Providing Caregiver Respite by Managing BPSDs and Improving QoL in People With Dementia Using Immersive VR-Therapy

Sponsor

University Health Network, Toronto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05867641

Collaborator

Centre for Aging and Brain Health Innovation (Other), Ontario AHSC AFP Innovation Fund (Other)

Enrollment

Locations

Arm

20.1

Anticipated Duration (Months)

7.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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:

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 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, interactive, or co-operative) 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 3 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 1-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), (2) play a simple game (e.g., using a hand controller to water plants), or (3) experience VR together with a researcher, who will join the session remotely.

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 web-based 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).

Condition or Disease	Intervention/Treatment	Phase
Dementia	Behavioral: Immersive VR Therapy in Head-Mounted Device (HMD)	N/A

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) 360-degree videos that simulate real-life environments (the ocean, watching a ballet), (2) a simple and rewarding game, and (3) co-operative, where a researcher will join and interact remotely. Participants will use VR&R at home for up to 30 minutes at a time, for three 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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pragmatic interventional trial including a three-week home-based intervention and one-week follow-up.Pragmatic interventional trial including a three-week home-based intervention and one-week follow-up.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

VR&R: Providing Respite to Caregivers by Managing BPSDs and Improving QoL in People With Dementia Using Immersive VR-Therapy

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: VR&R Therapy 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.	Behavioral: Immersive VR Therapy in Head-Mounted Device (HMD) 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 three weeks. The caregiver will use the custom "VR&R" web-based application on their personal device (laptop, tablet, or mobile phone) 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). Other Names: "VR&R Therapy"

Arm

Intervention/Treatment

Other: VR&R Therapy

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.

Behavioral: Immersive VR Therapy in Head-Mounted Device (HMD)

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 three weeks. The caregiver will use the custom "VR&R" web-based application on their personal device (laptop, tablet, or mobile phone) 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).

Other Names:

"VR&R Therapy"

Outcome Measures

Primary Outcome Measures

Change in Caregiver Respite and Burden: Short Zarit Burden Interview [4 Weeks]
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.
Change in Caregiver Respite and Burden: Caregiver Phone Interview [4 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.
Caregiver Respite and Burden: Post-Session Log [3 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.

Secondary Outcome Measures

Change in PwD Behavioural and Psychological Symptoms of Dementia: Apathy [4 Weeks]
A modified version of the Apathy Evaluation Scale (AES) will be completed by the caregiver to measure symptoms related to apathy.
Change in PwD Behavioural and Psychological Symptoms of Dementia: Depression [4 Weeks]
The Short Geriatric Depression Scale (GDS) and will be completed by participants with dementia. The GDS is a 15-item questionnaire employing "yes/no" response options that has been validated for use with individuals with mild to moderate cognitive impairment.
Change in PwD Behavioural and Psychological Symptoms of Dementia: Neuropsychiatric Symptoms [4 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.
Change in PwD and Caregiver Quality of Life [4 Weeks]
Quality of Life in Alzheimer's Dementia (QoL-AD) will be administered to participants with dementia and caregiver-participants to evaluate subjective quality of life. The QoL-AD is a 13-item questionnaire employing 4-point Likert scales. Calculated scores range from 0-52. Higher scores indicate greater subjective quality of life.
Change in PwD and Caregiver Well-Being [4 Weeks]
WHO-5 Well-Being Index will be administered to participants with dementia and 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.
Immediate Impact of Intervention on PwD Mood [3 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.)

Other Outcome Measures

Usability/Preference: System Usability Scale (SUS) [4 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.
Usability/Preference: Semi-Structured Interviews [4 Weeks]
Both participants will take part in a semi-structured interview post-intervention. The interview will include open-ended questions to explore the acceptability and usability the 3 different VR-mediums, including suggestions for improvement.
PwD Preferences/Reactions to VR [Baseline]
ObsRVR Tool: During the initial home training (pre-intervention), the researcher will score the participant's reactions to each of the 3 VR mediums using the ObsRVR tool. This tool was specifically designed to capture the reactions of individuals with dementia while using VR and includes quantitative and qualitative ratings of positive reactions (engagement, enjoyment, relaxation), negative reactions (anxiety/apprehension, sadness, aggression) and reminiscence.
PwD Simulator Sickness [Baseline]
During the initial home training (pre-intervention), the researcher will observe the participant's reactions to each of the 3 VR mediums. After each medium, the researcher will administer a modified version of the MIsery SCale (MISC), a self-report measure of motion sickness (scale of 0-10 where 0 = "No Problems" and 10 = "Vomiting"). Participants who score 4 or more (i.e., "rather" dizzy/sweating/salivating) on the scale for at least two out of three of the VR mediums will be withdrawn from the study.
PwD Preferences/Reactions to VR: Post-Session Experience Ratings [3 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 [3 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 [3 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 [3 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: Progression within the Game [3 Weeks]
This objective metrics of VR usage will be will be unobtrusively collected through the VR&R application for the duration of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acclaim Health	Oakville	Ontario	Canada	L6L 5M2
2	Chester Village	Toronto	Ontario	Canada	M1L 1E3
3	Circle of Care	Toronto	Ontario	Canada	M2P 2A9
4	Alzheimer's Society Toronto	Toronto	Ontario	Canada	M4R 1K8