A Virtual Reality at Home Intervention for People Living With Dementia (VRx@Home)

University Health Network, Toronto

Status: Active, not recruiting

Conditions: Dementia

Treatments: Device: Virtual Reality; Device: Tablet-Only

Study type: Interventional

Funder types: Other

Identifiers

NCT06568211

21-5701

163902 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

• report having dementia
• currently living at home

PLwD exclusion criteria:

• recent history of seizure, epilepsy, head trauma, or stroke
• pacemaker
• cervical conditions or injuries
• open face wounds
• alcohol-related dementia/Korsakoff syndrome
• having a Public Guardian and Trustee as substitute decision maker

Care partner inclusion criteria:

• identify as one of the primary care partners for the PLwD
• able to speak and understands English
• 18 years and older

Care partner exclusion criteria:

• professional/formal care partners for the PLwD
• unable to provide informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A: VR first

Experimental group

Description:

Those assigned to Group A will be placed in the Virtual Reality (VR) intervention phase first. All participants will begin with a baseline picture book condition (week 0), and then those in Group A, will complete the VR intervention condition in the first two weeks (weeks 1 \& 2). After completing the two weeks of VR intervention, participating families will be asked to complete a set of standardized questionnaires. The following next two weeks (weeks 3 \& 4), participants will complete the Tablet-only intervention phase. At the end of this phase, participating families will again complete the same standardized questionnaires and will participate in a semi-structured interview about their experiences. Each session is expected to include 20 minutes of VR exposure. Each session will also be video-recorded for later analyses.

Treatment:

Device: Tablet-Only

Device: Virtual Reality

Group B: Tablet-only first

Experimental group

Description:

Those assigned to Group B will be placed in the Tablet-only intervention phase first. All participants will begin with a baseline picture book condition (week 0), and then those in Group B, will complete the Tablet-only condition in the first two weeks (weeks 1 \& 2). After completing the two weeks of Tablet-only intervention, participating families will be asked to complete a set of standardized questionnaires. The following next two weeks (weeks 3 \& 4), participants will complete the VR intervention phase. At the end of this phase, participating families will again complete the same standardized questionnaires and will participate in a semi-structured interview about their experiences. Each session is expected to include 20 minutes of VR exposure. Each session will also be video-recorded for later analyses.

Treatment:

Device: Tablet-Only

Device: Virtual Reality