VR&R: Providing Caregiver Respite by Managing BPSDs and Improving QoL in People with Dementia Using Immersive VR-Therapy

NCT05867641 | Recruiting

• 1 other identifier: VR&R
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

The goal of this interventional trial is to learn about how immersive Virtual Reality (VR) therapy can be used at home by individuals with dementia, with assistance from their informal (e.g., friend/family) caregivers. The main question it aims to answer are:

• Take part in an initial at-home VR technology training session and complete a series of brief questionnaires (e.g., health history/technology use, well-being/quality of life, symptoms of dementia)
• Use "VR\&R" (VR Rest \& Relaxation Therapy) for a period of 4 weeks (30 minute sessions, desired frequency), and answer a brief set of questions after each VR\&R session
• Provide feedback on the VR\&R intervention in semi-structured interview with the researcher and answer additional questionnaires at a 2-week follow-up During VR\&R sessions, participants with dementia will have the opportunity to choose to watch (1) immersive 360-degree videos (e.g., of a live performance, or beach) on their own and (2) experience the same VR videos together with a researcher. Caregivers will be asked to assist their loved one with dementia to use VR\&R by helping to put on the VR headset, selecting a VR experience through a user-friendly application, and remaining nearby to supervise and provide assistance as needed. During VR\&R sessions, caregivers may use this time to take a personal break or complete short tasks (e.g., make a cup of coffee, have an uninterrupted phone call).

Conditions

Dementia

Keywords

Non-pharmacological; Caregiver Respite; Virtual Reality; Home Based Care; Quality of Life; Behavioral and psychological symptoms of dementia; Mood; Well-Being; Serious Game

Outcome Measures

Primary Outcomes (5)

• Change in Caregiver Respite and Burden

  Unpaid Caregivers: Short Zarit Burden Interview 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. Total scores range from 0-24 where higher scores indicate greater feelings of caregiver burden. Paid Caregivers: Professional Care Team Burden Scale The 10-item Professional Care Team Burden (PCTB) Scale is a validated tool designed to assess the burden experienced by professional caregivers working in dementia care settings such as nursing homes. It evaluates three dimensions of burden: subjective burden (individual emotional strain), organizational burden (workplace factors), and structural burden (systemic or institutional challenges).

  6 Weeks

• Change in Caregiver Respite and Burden: Caregiver Phone Interview

  The caregiver will be asked to take part in a pre- and post- intervention phone interview (approximately 15 minutes in length, audio-recorded). The interview will include open-ended questions to gather qualitative information on the impact of the VR intervention on the caregiver and PwD (i.e., whether there were any changes to baseline PwD \& caregiver well-being/QoL, BPSD, caregiver burden, and caregiver respite following the intervention), as well as feedback on the VR mediums in terms of their ability to promote caregiver respite.

  6 Weeks

• Change Caregiver Well-Being

  WHO-5 Well-Being Index will be administered to caregiver-participants to evaluate subjective wellbeing. The WHO (Five) is a 5-item questionnaire employing 6-point Likert scales. Calculated scores range from 0-25. A score of 0 represents the worst possible and a score of 25 represents the best possible quality of life. A score below 13 represents poor wellbeing. A change of 10% represents a significant change in wellbeing.

  6 Weeks

• Change in Caregiver Respite and Burden: Post-Session Log

  Caregivers will be asked to describe their time while the PwD was using VR in a paper-based log. This tool aims to capture if the caregiver was able to obtain additional respite, and the degree to which they were able to obtain respite (i.e., the degree to which caregivers were able to remain vigilant and at the same time detach and focus on their own task). Caregivers will also have the opportunity to record observations of the PwD's reactions to/experience with the VR intervention, as well as additional feedback and reflections of their own or from discussion with the PwD.

  4 Weeks

• Change in Caregiver Resilience

  The 10-item Connor-Davidson Resilience Scale (CD-RISC) is a condensed version of the original 25-item scale, designed to efficiently measure resilience, the ability to adapt and thrive in the face of adversity. Each of its 10 items is rated on a 5-point Likert scale, with higher scores indicating greater resilience. The scale emphasizes key resilience traits such as adaptability, persistence, and emotional regulation. Validated across diverse populations, it has shown strong reliability, internal consistency, and construct validity. Its brevity and ease of use make it a valuable tool for both research and clinical settings, especially when time is limited.

  6 Weeks

Secondary Outcomes (2)

• Change in PwD Behavioural and Psychological Symptoms of Dementia: Neuropsychiatric Symptoms

  6 Weeks

• Immediate Impact of Intervention on PwD Mood

  4 Weeks

Other Outcomes (9)

• Usability/Preference: System Usability Scale (SUS)

  6 Weeks

• Usability/Preference: Semi-Structured Interviews

  6 Weeks

• PwD Simulator Sickness

  Baseline

Study Arms (2)

VR&R Therapy - Solo First

EXPERIMENTAL

Recruited dyads will include one person diagnosed with dementia and their caregiver (e.g., family/friend). The caregiver will assist their loved ones with dementia to use VR-therapy at home. Caregivers may use the time while their loved ones are engaged for respite, remaining nearby to supervise and assist. For the first two weeks, only the caregiver will be present to use VR with the person with dementia. For the following two weeks, a research assistant will be present to use VR with the person with dementia.

Behavioral: Immersive VR Therapy in Head-Mounted Display (HMD) (Solo); Behavioral: Immersive VR Therapy in a Head-Mounted Display (HMD) (Social)

VR&R Therapy - Social First

EXPERIMENTAL

Recruited dyads will include one person diagnosed with dementia and their caregiver (e.g., family/friend). The caregiver will assist their loved ones with dementia to use VR-therapy at home. Caregivers may use the time while their loved ones are engaged for respite, remaining nearby to supervise and assist. For the first two weeks, a research assistant will be present to use VR with the person with dementia. For the following two weeks, only the caregiver will be present.

Behavioral: Immersive VR Therapy in Head-Mounted Display (HMD) (Solo); Behavioral: Immersive VR Therapy in a Head-Mounted Display (HMD) (Social)

Interventions

Immersive VR Therapy in a Head-Mounted Display (HMD) (Social) BEHAVIORAL

Participants with dementia will view immersive VR experiences using a commercially-available VR head-mounted device for up to 30 minutes a time, 2 to 3 times per week, for 2 weeks. A research assistant who is trained in dementia care will use the custom application on a tablet to select and monitor what their loved one sees in VR. Staying nearby to monitor for safety and assistance, the caregiver may choose to use the time when their loved one is engaged to take some respite time for themselves (e.g., make a cup of coffee, have an uninterrupted phone call).

Also known as: Social VR Therapy

VR&R Therapy - Social First; VR&R Therapy - Solo First

Immersive VR Therapy in Head-Mounted Display (HMD) (Solo) BEHAVIORAL

Caregivers will be trained to administer VR\&R therapy to their loved ones with dementia, in their private home/residence. Participants with dementia will view immersive VR experiences using a commercially-available VR head-mounted device for up to 30 minutes a time, approximately every other day (or as desired), for two weeks. The caregiver will use the custom application on a tablet to select and monitor what their loved one sees in VR. Staying nearby to monitor for safety and assistance, the caregiver may choose to use the time when their loved one is engaged to take some respite time for themselves (e.g., make a cup of coffee, have an uninterrupted phone call).

Also known as: Solo VR Therapy

VR&R Therapy - Social First; VR&R Therapy - Solo First

Eligibility Criteria

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

You may qualify if:

• Individuals who are 65 years of age or older
• Individuals living at home with a family caregiver
• Individuals diagnosed with dementia

You may not qualify if:

• Individuals with open wounds on face (sutured lacerations exempted)
• Individuals with a history of seizures or epilepsy
• Individuals with a pacemaker
• Individuals with head trauma or stroke leading to their current admission
• Individuals with cervical conditions or injuries that would make it unsafe for them to use the VR headset
• Individuals who identify as being legally blind
• Individuals with alcohol related dementia/ Korsakoff syndrome.
• Individuals who have a Public Guardian and Trustee (PGT) as Substitute Decision Maker (SDM)
• Individuals who cannot speak and understand English
• Individuals who identify as a primary caregiver for the PwD
• Individuals who have access to the internet through a device (computer, tablet, or mobile phone) that can be used during the study
• Individuals who cannot speak and understand English
• Individuals who are cognitively unable to provide informed consent for themselves
• Identify as legally blind

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Centre for Aging and Brain Health Innovation: collaborator
• Ontario AHSC AFP Innovation Fund: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (7)

Acclaim Health

Oakville, Ontario, L6L 5M2, Canada

RECRUITING

Chester Village

Toronto, Ontario, M1L 1E3, Canada

RECRUITING

Circle of Care

Toronto, Ontario, M2P 2A9, Canada

RECRUITING

Toronto Grace Hospital - Main Site

Toronto, Ontario, M4Y 2G5, Canada

ACTIVE NOT RECRUITING

Toronto Grace Hospital - Remote Care Monitoring

Toronto, Ontario, M4Y 2G5, Canada

RECRUITING

Toronto Grace Hospital - Specialized Care Centre

Toronto, Ontario, M4Y 2G5, Canada

RECRUITING

McGill Dementia Education Centre

Montreal, Quebec, H3G 2M1, Canada

NOT YET RECRUITING

Related Publications (10)

• Anderson-Hanley C, Arciero PJ, Brickman AM, Nimon JP, Okuma N, Westen SC, Merz ME, Pence BD, Woods JA, Kramer AF, Zimmerman EA. Exergaming and older adult cognition: a cluster randomized clinical trial. Am J Prev Med. 2012 Feb;42(2):109-19. doi: 10.1016/j.amepre.2011.10.016.

  PMID: 22261206 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

• Appel L, Kisonas E, Appel E, Klein J, Bartlett D, Rosenberg J, Smith C. Introducing virtual reality therapy for inpatients with dementia admitted to an acute care hospital: learnings from a pilot to pave the way to a randomized controlled trial. Pilot Feasibility Stud. 2020 Oct 31;6(1):166. doi: 10.1186/s40814-020-00708-9.

  PMID: 33292729 BACKGROUND

• Appel L, Kisonas E, Appel E, Klein J, Bartlett D, Rosenberg J, Smith CN. Administering Virtual Reality Therapy to Manage Behavioral and Psychological Symptoms in Patients With Dementia Admitted to an Acute Care Hospital: Results of a Pilot Study. JMIR Form Res. 2021 Feb 3;5(2):e22406. doi: 10.2196/22406.

  PMID: 33533720 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

• Baker JR, Webster L, Lynn N, Rogers J, Belcher J. Intergenerational Programs May Be Especially Engaging for Aged Care Residents With Cognitive Impairment: Findings From the Avondale Intergenerational Design Challenge. Am J Alzheimers Dis Other Demen. 2017 Jun;32(4):213-221. doi: 10.1177/1533317517703477.

  PMID: 28506126 BACKGROUND

• D'Cunha NM, Nguyen D, Naumovski N, McKune AJ, Kellett J, Georgousopoulou EN, Frost J, Isbel S. A Mini-Review of Virtual Reality-Based Interventions to Promote Well-Being for People Living with Dementia and Mild Cognitive Impairment. Gerontology. 2019;65(4):430-440. doi: 10.1159/000500040. Epub 2019 May 20.

  PMID: 31108489 BACKGROUND

• Dermody G, Whitehead L, Wilson G, Glass C. The Role of Virtual Reality in Improving Health Outcomes for Community-Dwelling Older Adults: Systematic Review. J Med Internet Res. 2020 Jun 1;22(6):e17331. doi: 10.2196/17331.

  PMID: 32478662 BACKGROUND

• Huygelier H, Schraepen B, van Ee R, Vanden Abeele V, Gillebert CR. Acceptance of immersive head-mounted virtual reality in older adults. Sci Rep. 2019 Mar 14;9(1):4519. doi: 10.1038/s41598-019-41200-6.

  PMID: 30872760 BACKGROUND

• Munoz J, Mehrabi S, Li Y, Basharat A, Middleton LE, Cao S, Barnett-Cowan M, Boger J. Immersive Virtual Reality Exergames for Persons Living With Dementia: User-Centered Design Study as a Multistakeholder Team During the COVID-19 Pandemic. JMIR Serious Games. 2022 Jan 19;10(1):e29987. doi: 10.2196/29987.

  PMID: 35044320 BACKGROUND

Related Links

• VR\&R Project Website

MeSH Terms

Conditions

Dementia; Behavior

Interventions

Smart Glasses; Oxymetholone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Lora Appel, PhD

CONTACT

6475046537; lora.appel@yorku.ca

Lora Appel, PhD

CONTACT

lora.appel@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pragmatic crossover interventional trial including a four-week home-based intervention (two weeks per condition) and two-week follow-up.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: May 22, 2023
• Study Start: February 12, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)