VRx@Home: Study to Evaluate VR-therapy for PwD Living at Home

NCT04988360 | Completed

• 1 other identifier: VRx@Home Pilot
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators are designing and rigorously evaluating the first Virtual Reality-therapy program for people with dementia (PwD) living at home, administered by their informal caregivers (family/friends). Virtual Reality (VR) presents a unique opportunity to transport people to a world outside of their confined spaces, into calming and stimulating settings (lush forest, peaceful beach, cheerful playground). Virtual Reality-therapy is a non-pharmacological approach that uses VR "experiences'' to stimulate brain function, improve psychological health, engage, and relax. It has potential to reduce symptoms of dementia such as apathy, depression, loneliness, sundowning, and the use of sedating medications with known negative side-effects. Caregivers of PwD are more likely to feel worried, tired, overwhelmed, and depressed than non-PwD caregivers. Symptoms of dementia and caregiver stress often result in early institutionalization of PwD; management of challenging symptoms may help PwD remain in their homes for longer while improving their, and their caregivers', Quality of Life (QoL). Addressing the wellbeing of caregivers is an often overlooked, yet integral part of interventions for PwD. It ensures intervention feasibility but also has a distinct impact on our system, reducing healthcare needs of caregivers and allowing them to continue contributing as caregivers. In this pilot study the investigators will train and assist caregivers to conduct Virtual Reality-therapy with their loved-ones at home using two devices: a head-mounted display and a tablet. This pilot study will assess: (1) the acceptability of the VR devices (2) feasibility of the study methods, (3) the impact of VR-therapy on PwD and caregiver outcomes. These findings will be used to inform a future randomized controlled trial (RCT).

Conditions

Dementia

Keywords

Virtual Reality; Tablets; Interpersonal Relations; Community Health Services; Apathy; Depressive Symptoms; Behavioral Symptoms; Quality of Life; Caregivers; Spouse Caregivers; Family Caregivers

Outcome Measures

Primary Outcomes (4)

• Usability scores of first VR intervention used

  System Usability Scale (SUS) will be administered to evaluate device usability/ease-of-use of the first type of VR intervention used during the study: head-mounted device (HMD) for participant group A, and tablet for participant group B). Each participant (caregiver and person with dementia) will complete this questionnaire after 2 weeks of using the respective VR intervention. The SUS is a 10-item questionnaire employing 5-point Likert scales. Calculated scores range from 0-100. Higher scores indicate better system usability.

  Day 14 of participation

• Usability scores of second VR intervention used

  System Usability Scale (SUS) will be administered to evaluate device usability/ease-of-use of the second type of VR intervention used during the study: head-mounted device (HMD) for participant group B, and tablet for participant group A. Each participant (caregiver and person with dementia) will complete this questionnaire after 2 weeks of using the respective VR intervention. The SUS is a 10-item questionnaire employing 5-point Likert scales. Calculated scores range from 0-100. Higher scores indicate better system usability.

  Day 28 of participation

• Appropriateness of the study procedures for feasible use of VR-therapy in the home using first intervention

  Semi-structured interview questions will assess opinions on the devices and VR-therapy program experience including: (1) Device comfort, (2) Device tolerance, (3) Content preferences, (4) Challenges, (5) Areas for program improvement, (6) Willingness to continue to use VR, (7) Willingness to recommend VR to others, (8) Open-ended question to capture any other opinions or concerns. Both participants (caregiver and person with dementia) will also complete informal personal reflections about the sessions to capture any feelings, observations, or opinions about VR or the study procedures not otherwise collected by the study tools.

  Day 14 of participation

• Appropriateness of the study procedures for feasible use of VR-therapy in the home using second intervention

  Semi-structured interview questions will assess opinions on the devices and VR-therapy program experience including: (1) Device comfort, (2) Device tolerance, (3) Content preferences, (4) Challenges, (5) Areas for program improvement, (6) Willingness to continue to use VR, (7) Willingness to recommend VR to others, (8) Open-ended question to capture any other opinions or concerns. Both participants (caregiver and person with dementia) will also complete informal personal reflections about the sessions to capture any feelings, observations, or opinions about VR or the study procedures not otherwise collected by the study tools.

  Day 28 of participation

Secondary Outcomes (12)

• Change from baseline perceived relationship quality within the participant dyad scores

  Days 1, 14, and 28 of participation

• Change from baseline apathy scores in participants with dementia

  Days 1, 14, and 28 of participation

• Change from baseline depression scores in participants with dementia

  Days 1, 14, and 28 of participation

• Change from baseline depression scores in participants with dementia

  Days 1, 14, and 28 of participation

• Change from baseline behavioural disturbance scores in participants with dementia

  Days 1, 14, and 28 of participation

Study Arms (2)

Group A: HMD first

EXPERIMENTAL

Those assigned to group A will use the head-mounted display (HMD) VR intervention first. Caregivers will be trained to use the HMD-system and asked to use that system for the duration of T1 (weeks 1 \& 2). At the end of T1 they will be asked to complete standardized questionnaires and will participate in a semi-structured interview about their experiences. At the beginning of T2 (weeks 3 \& 4), they will then be trained to use the tablet-system, which will be used for the duration of T2. At the completion of T2, the dyad 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 throughout T1 and T2 is to be video-recorded by the caregiver-participant so that reactions and interactions can later be analyzed.

Device: HMD: Immersive VR; Device: Tablet: Non-immersive VR

Group B: Tablet first

EXPERIMENTAL

Those assigned to group B will use the tablet VR intervention first. Caregivers will be trained to use the tablet-system and asked to use that system for the duration of T1 (weeks 1 \& 2). At the end of T1 they will be asked to complete standardized questionnaires and will participate in a semi-structured interview about their experiences. At the beginning of T2 (weeks 3 \& 4), they will then be trained to use the HMD-system, which will be used for the duration of T2. At the completion of T2, the dyad 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 throughout T1 and T2 is to be video-recorded by the caregiver-participant so that reactions and interactions can later be analyzed.

Device: HMD: Immersive VR; Device: Tablet: Non-immersive VR

Interventions

HMD: Immersive VR DEVICE

Participants with dementia will view 360-degree films using a commercially-available Virtual Reality head mounted display (HMD) that has built-in speakers. While wearing the HMD, participants with dementia will be able to visually explore the virtual environments by turning their head to face different directions. Caregivers-participants will take part in the VR experience concurrently by viewing a tablet that is connected to the HMD through the "screen mirroring" function.

Also known as: Head-mounted display, Headset

Group A: HMD first; Group B: Tablet first

Tablet: Non-immersive VR DEVICE

Participants with dementia will view 360-degree films on a commercially-available tablet that has built-in speakers. Participants with dementia will be able to visually explore the virtual environment using the touch screen (dragging the view around with one's finger). Caregiver-participants will take part in the VR experience concurrently by viewing the tablet while sitting or standing beside the participant with dementia.

Group A: HMD first; Group B: Tablet 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 mild to moderate 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 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
• Live with a PwD
• Identify as a primary caregiver for the PwD
• Individuals who cannot speak and understand English
• Individuals who are professional/formal caregivers for the PwD
• Individuals who are cognitively unable to provide informed consent for themselves

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Centre for Aging and Brain Health Innovation: collaborator

Study Sites (2)

Acclaim Health

Oakville, Ontario, L6L 5M2, Canada

Location

Circle of Care

Toronto, Ontario, M2P 2A9, Canada

Location

Related Publications (13)

• 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

• Berman MG, Kross E, Krpan KM, Askren MK, Burson A, Deldin PJ, Kaplan S, Sherdell L, Gotlib IH, Jonides J. Interacting with nature improves cognition and affect for individuals with depression. J Affect Disord. 2012 Nov;140(3):300-5. doi: 10.1016/j.jad.2012.03.012. Epub 2012 Mar 31.

  PMID: 22464936 BACKGROUND

• Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217-28. doi: 10.31887/DCNS.2009.11.2/hbrodaty.

  PMID: 19585957 BACKGROUND

• Diette GB, Lechtzin N, Haponik E, Devrotes A, Rubin HR. Distraction therapy with nature sights and sounds reduces pain during flexible bronchoscopy: a complementary approach to routine analgesia. Chest. 2003 Mar;123(3):941-8. doi: 10.1378/chest.123.3.941.

  PMID: 12628899 BACKGROUND

• Hughes JC, Louw SJ. Electronic tagging of people with dementia who wander. BMJ. 2002 Oct 19;325(7369):847-8. doi: 10.1136/bmj.325.7369.847. No abstract available.

  PMID: 12386013 BACKGROUND

• Morita E, Fukuda S, Nagano J, Hamajima N, Yamamoto H, Iwai Y, Nakashima T, Ohira H, Shirakawa T. Psychological effects of forest environments on healthy adults: Shinrin-yoku (forest-air bathing, walking) as a possible method of stress reduction. Public Health. 2007 Jan;121(1):54-63. doi: 10.1016/j.puhe.2006.05.024. Epub 2006 Oct 20.

  PMID: 17055544 BACKGROUND

• Park BJ, Tsunetsugu Y, Kasetani T, Kagawa T, Miyazaki Y. The physiological effects of Shinrin-yoku (taking in the forest atmosphere or forest bathing): evidence from field experiments in 24 forests across Japan. Environ Health Prev Med. 2010 Jan;15(1):18-26. doi: 10.1007/s12199-009-0086-9.

  PMID: 19568835 BACKGROUND

• Park SH, Mattson RH. Ornamental indoor plants in hospital rooms enhanced health outcomes of patients recovering from surgery. J Altern Complement Med. 2009 Sep;15(9):975-80. doi: 10.1089/acm.2009.0075.

  PMID: 19715461 BACKGROUND

• Posch M, Bauer P, Brannath W. Issues in designing flexible trials. Stat Med. 2003 Mar 30;22(6):953-69. doi: 10.1002/sim.1455.

  PMID: 12627412 BACKGROUND

• Robinson L, Hutchings D, Corner L, Beyer F, Dickinson H, Vanoli A, Finch T, Hughes J, Ballard C, May C, Bond J. A systematic literature review of the effectiveness of non-pharmacological interventions to prevent wandering in dementia and evaluation of the ethical implications and acceptability of their use. Health Technol Assess. 2006 Aug;10(26):iii, ix-108. doi: 10.3310/hta10260.

  PMID: 16849002 BACKGROUND

• Ulrich RS. View through a window may influence recovery from surgery. Science. 1984 Apr 27;224(4647):420-1. doi: 10.1126/science.6143402.

  PMID: 6143402 BACKGROUND

Related Links

• Virtual Reality Aimed At The Elderly Finds New Fans
• People with dementia test-drive virtual reality rehabilitation system used by injured soldiers to help their condition

MeSH Terms

Conditions

Dementia; Lethargy; Depression; Behavioral Symptoms

Interventions

Smart Glasses

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; 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: PRINCIPAL INVESTIGATOR
• PI Title: Post-doc Research Fellow; Assistant Professor

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: August 3, 2021
• Study Start: May 10, 2022
• Primary Completion: September 17, 2022
• Study Completion: September 17, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)