A Virtual Reality at Home Intervention for People Living With Dementia

NCT06568211 | Active Not Recruiting

• 2 other identifiers: 21-5701163902
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Dementia

Keywords

Virtual Reality; Tablet; Reminiscence; Verbal communication; Nonverbal communication; Interpersonal Relationship; Quality of Life; Well-Being; Person Living with Dementia; Care Partner

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Quality of Life

  Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)

• Well-Being

  Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)

• Caregiver Burden

  Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)

• Usability/Preference

  Measure will be collected after each phase of the intervention (end of week 2 and week 4)

Study Arms (2)

Group A: VR first

EXPERIMENTAL

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; Device: Tablet-Only

Group B: Tablet-only first

EXPERIMENTAL

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; Device: Tablet-Only

Interventions

Virtual Reality DEVICE

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.

Also known as: VR, HMD

Group A: VR first; Group B: Tablet-only first

Tablet-Only DEVICE

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).

Also known as: Tablet

Group A: VR first; Group B: Tablet-only first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• report having dementia
• currently living at home
• 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
• identify as one of the primary care partners for the PLwD
• able to speak and understands English
• years and older
• professional/formal care partners for the PLwD
• unable to provide informed consent

Sponsors & Collaborators

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

Study Sites (1)

KITE Research Institute, University Health Network

Toronto, Ontario, M5G 2A2, Canada

Location

Related Publications (6)

• 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.

  PMID: 35877169 BACKGROUND

• 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.

  PMID: 33322679 BACKGROUND

• 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.

  PMID: 35024166 BACKGROUND

• 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.

  PMID: 38289666 BACKGROUND

• 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.

  PMID: 32010701 BACKGROUND

• Saryazdi R, Appel L, Lewis-Fung S, Carsault LA, Qi D, Garcia-Giler E, Campos JL. VRx@Home protocol: A virtual reality at-home intervention for persons living with dementia and their care partners. BMJ Open. 2024 Dec 20;14(12):e085442. doi: 10.1136/bmjopen-2024-085442.

  PMID: 39806619 DERIVED

MeSH Terms

Conditions

Dementia; Nonverbal Communication

Interventions

Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Communication; Behavior

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 23, 2024
• Study Start: November 17, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)