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

VRx@Home: A Virtual Reality At-Home Intervention for Persons Living With Dementia and Their Care Partners

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

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia
• Intervention / Treatment: Device: Virtual Reality; Device: Tablet-Only

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2A2
      • KITE Research Institute, University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: VR first; 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.	Device: Virtual Reality; 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; Device: Tablet-Only; 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
Experimental: Group B: Tablet-only first; 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.	Device: Virtual Reality; 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; Device: Tablet-Only; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of conversation and dyadic interactions (observations)	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).	Measures will be collected from baseline until the end of the intervention (week 4).
Quality of conversation and dyadic interactions (self-report)	Participating families will complete a communication questionnaire.	Measures will be collected from baseline until the end of the intervention (week 4).
Verbal Communication	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.	Measures will be collected from baseline through the end of intervention (week 4)
Nonverbal Communication	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.	Measures will be collected from baseline through the end of intervention (week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	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.	Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
Well-Being	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.	Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
Caregiver Burden	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.	Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
Usability/Preference	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.	Measure will be collected after each phase of the intervention (end of week 2 and week 4)

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Canadian Institutes of Health Research (CIHR); AGE-WELL, Inc; Associated Medical Services

Publications and helpful links

General Publications

• Coelho T, Marques C, Moreira D, Soares M, Portugal P, Marques A, Ferreira AR, Martins S, Fernandes L. Promoting Reminiscences with Virtual Reality Headsets: A Pilot Study with People with Dementia. Int J Environ Res Public Health. 2020 Dec 12;17(24):9301. doi: 10.3390/ijerph17249301.
• Appel L, Appel E, Bogler O, Wiseman M, Cohen L, Ein N, Abrams HB, Campos JL. Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. Front Med (Lausanne). 2020 Jan 15;6:329. doi: 10.3389/fmed.2019.00329. eCollection 2019.
• Appel L, Ali S, Narag T, Mozeson K, Pasat Z, Orchanian-Cheff A, Campos JL. Virtual reality to promote wellbeing in persons with dementia: A scoping review. J Rehabil Assist Technol Eng. 2021 Dec 21;8:20556683211053952. doi: 10.1177/20556683211053952. eCollection 2021 Jan-Dec.
• Huang LC, Yang YH. The Long-term Effects of Immersive Virtual Reality Reminiscence in People With Dementia: Longitudinal Observational Study. JMIR Serious Games. 2022 Jul 25;10(3):e36720. doi: 10.2196/36720.
• Appel L, Appel E, Kisonas E, Lewis-Fung S, Pardini S, Rosenberg J, Appel J, Smith C. Evaluating the Impact of Virtual Reality on the Behavioral and Psychological Symptoms of Dementia and Quality of Life of Inpatients With Dementia in Acute Care: Randomized Controlled Trial (VRCT). J Med Internet Res. 2024 Jan 30;26:e51758. doi: 10.2196/51758.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Virtual Reality; Reminiscence; Tablet; Well-Being; Nonverbal communication; Care Partner; Verbal communication; Interpersonal Relationship; Person Living with Dementia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 21-5701; 163902 (Other Grant/Funding Number: Canadian Consortium on Neurodegeneration in Aging Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No