Clinical trial NCT06568211: A Virtual Reality at Home Intervention for People Living With Dementia
Official title: VRx@Home: A Virtual Reality At-Home Intervention for Persons Living With Dementia and Their Care Partners
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Keywords: Virtual Reality
Tablet
Reminiscence
Verbal communication
Nonverbal communication
Interpersonal Relationship
Quality of Life
Well-Being
Person Living with Dementia
Care Partner
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: AGE-WELL, Inc
name: Canadian Institutes of Health Research (CIHR)
name: Associated Medical Services
First posted: 2024-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

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.

Eligibility 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

Primary outcomes:
measure: Quality of conversation and dyadic interactions (observations)
timeFrame: Measures will be collected from baseline until the end of the intervention (week 4).
measure: Quality of conversation and dyadic interactions (self-report)
timeFrame: Measures will be collected from baseline until the end of the intervention (week 4).
measure: Verbal Communication
timeFrame: Measures will be collected from baseline through the end of intervention (week 4)
measure: Nonverbal Communication
timeFrame: Measures will be collected from baseline through the end of intervention (week 4)
Secondary outcomes:
measure: Quality of Life
timeFrame: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
measure: Well-Being
timeFrame: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
measure: Caregiver Burden
timeFrame: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
measure: Usability/Preference
timeFrame: Measure will be collected after each phase of the intervention (end of week 2 and week 4)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: KITE Research Institute, University Health Network
state: Ontario
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.