KITE Research Institute, University Health Network
Toronto, Ontario, M5G 2A2, Canada
NCT Number: NCT06568211
The goal of the current study is to design and evaluate a virtual reality (VR) at-home intervention to facilitate communication between persons living with dementia (PLwD) and their family/friend care partners, and in turn improve their interpersonal relationships and quality of life. The project also aims to provide a direct comparison of an immersive VR system with non-immersive tablet-based technology.
PLwD and care partner interactions will be recorded during each of the following sessions and then used for the primary measure of verbal and non-verbal communication.
* Picture Book condition (baseline): PLwD and care partner view pictures together on photo album * VR condition: PLwD watch 360 degree videos on a VR and the care partner watches the same content concurrently on a paired tablet * Table-Only condition: PLwD and care partner watch 360 videos together on the tablet
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 2A2, Canada
Head Mounted VR headsets allow a person to transport to alternate realities such as visiting another country, attending a concert or a sporting event. The evidence to date suggests that VR experiences have positive impact on the well-being of individuals living with dementia. Most of this work however, has been in more formal settings whether it's long-term care or community programs, with trained formal care partners or researchers. Further, little work has explored specifically communication outcomes within the family dynamics.
After obtaining informed consent, participants will complete a Demographic and Health History questionnaire, and then will be scheduled for their first home visit. During this session, researcher will provide training on how to use the devices, how to video-record the study sessions, and how to complete study questionnaires through the supplied laptop. The PLwD and care partner will also view a picture book together while their interaction is being recorded through a video-conferencing software.
Participants will then begin the four weeks of intervention, where they will either be placed in the VR first intervention condition for the first two week or the Tablet-only first intervention condition (weeks 1 and 2), and then they will switch and receive the other device in the following two weeks (weeks 3 and 4). Participants will receive additional at-home training in-between two intervention phases. Irrespective of the condition, once a week participants will have a session with researcher over a video-conferencing software, where they watch a 20 mins video sequence that has a combination of 4 videos of different themes (animal, entertainment, travel, and sports) preselected for them. This is then followed by a short semi-structured interview asking participants about their preferences and experience. In addition, participants are asked to try the devices on their own and record their interactions.
In addition to the video recording of sessions which will be used for analyses of verbal and non-verbal communication, and interview data, participants will be asked to complete a set of questionnaires at baseline, and after each phase of the intervention. They will also be given a journal to note down any additional information they would like to share beyond those captures in interviews and questionnaires.
After completing the study, a final semi-structure interview will be conducted with participants to evaluate the overall feasibility and effectiveness of intervention. Study will complete with a final home visit to pick up devices.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Given the nature of the study, the participating dyads will be required to have access to high-speed internet with a reliable WiFi connection. Additional inclusion/exclusion criteria are as follows:
PLwD inclusion criteria:
PLwD exclusion criteria:
Care partner inclusion criteria:
Care partner exclusion criteria:
Persons living with dementia (PLwD) will view 360-degree videos using a commercially-available Virtual Reality (VR) head mounted display that has built-in speakers. While wearing the VR headset, PLwD-participant will be able to visually explore the virtual environments by turning their head to face different directions. Care partner-participants will take part in the VR experience concurrently by viewing a tablet that is connected to the VR headset through the "screen mirroring" function.
Other names: VR, HMD
PLwD and care partner will view 360-degree videos together on a commercially-available tablet that has built-in speakers. They will be able to visually explore the virtual environment using the touch screen (dragging the view around with their fingers).
Other names: Tablet
Time frame: Measures will be collected from baseline until the end of the intervention (week 4).
Trained research assistants will code the video recordings for the quality of participation, support, and engagement using the standardized Measure of Participation in Conversation for Dementia (focused on PLwD) and Measure of Support in Conversation for Dementia (focused on Care partner).
Time frame: Measures will be collected from baseline until the end of the intervention (week 4).
Participating families will complete a communication questionnaire.
Time frame: Measures will be collected from baseline through the end of intervention (week 4)
Trained research assistants will code the video recordings for measures of verbal communication (e.g., utterance length, coherence, reminiscence). This data will be analyzed through both qualitative and quantitative methods.
Time frame: Measures will be collected from baseline through the end of intervention (week 4)
Trained research assistants will code the video recordings for measures of nonverbal communication (e.g., gestures, familial expressions). This data will be analyzed through both qualitative and quantitative methods.
Time frame: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
The 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. Higher scores indicate greater subjective quality of life.
Time frame: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
The WHO (Five) Well-Being Index will be administered to participants living with dementia and caregiver-participants to evaluate subjective wellbeing. The WHO (Five) is a 5-item questionnaire employing 6-point Likert scales.
Time frame: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
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.
Time frame: Measure will be collected after each phase of the intervention (end of week 2 and week 4)
System Usability Scale (SUS) will be administered to evaluate device usability/ease-of-use for both VR and Tablet-only conditions. The SUS is a 10-item questionnaire employing 5-point Likert scales.
University Health Network, Toronto
Other
VRx@Home: A Virtual Reality At-Home Intervention for Persons Living With Dementia and Their Care Partners
Acronym: VRx@Home
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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