VRx@Home: Study to Evaluate VR-therapy for PwD Living at Home
NCT ID: NCT04988360
Last Updated: 2022-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2022-05-10
2022-09-17
Brief Summary
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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).
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Detailed Description
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After obtaining informed consent, the research coordinator will set up a time convenient to both parties (the researcher and participant dyad) to conduct a baseline semi-structured interview that collects demographics as well as a questionnaire consisting of validated instruments on the outcome measures of interest (e.g. quality of life, apathy, etc.) Once baselines data collection is complete, the dyad will be randomized into one of two study arms, determining which VR technology they will be using first: (A) HMD first (immersive VR), or (B) Tablet first (non-immersive VR). Those assigned to Group A will use the HMD for weeks 1-2 and the tablet for weeks 3-4. Those assigned to Group B will use the tablet for weeks 1-2 and the HMD for weeks 3-4. After randomization, the participants, caregivers, and research personnel will not be blind to treatment allocation given the nature of the interventions.
The benefits of this randomized crossover design include the: (1) ability to compare the outcomes between immersive VR (HMD system) and non-immersive VR (tablet-only system) where each dyad serves as their own control, reducing the effects of inter-individual variability or disease progression, (2) opportunity for all participants to use the VR HMD, and (3) ability to explore whether the intervention "washes-out" soon after each therapy period or if it has a carryover effect.
Irrespective of experimental arm (Group A or Group B), the intervention consists of therapy sessions administered five times per week, at times agreeable to the dyad, for a total of approximately 80 minutes per week (20 minutes per viewing, 4 times per week). Prior to each session, the caregiver-participant will commence video-recording via the video-conferencing application (as taught during the training session). Once the recording is confirmed, the participants may start their session. During each session, PwD should be seated in a comfortable and secure chair of their choice. Caregiver-participants will help PwD equip the device and launch the films. The participant dyad will be able to select from a wide range of films available on each device. Once the selected film starts to play, the caregiver-participant will be seated nearby to ensure the safety of the PwD and to jointly experience VR. Once the dyad has finished using VR and their discussions/interactions about VR have concluded, the caregiver-participant may stop the video recording. The video recording will be stored securely automatically. Each member of the study dyad will then complete a personal reflection about the study session.
In addition to the video-recording (used to analyze participant interaction and conduct conversation analysis) some data collection tools are meant to be filled in after each session. The remaining data is collected via a structured questionnaire containing validated instruments and open-ended questions filled in at Baseline (T0), at the end of Weeks 1-2 (T1), and at the end of Weeks 3-4 (T2), to gather experiences using both the VR and tablet devices, and potential impact on clinical outcomes. The usability of each VR technology will be assessed at the end of T1 and T2.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Group A: HMD first
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.
HMD: Immersive VR
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.
Tablet: Non-immersive VR
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 B: Tablet first
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.
HMD: Immersive VR
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.
Tablet: Non-immersive VR
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.
Interventions
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HMD: Immersive VR
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.
Tablet: Non-immersive VR
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals living at home with a family caregiver.
* Individuals diagnosed with mild to moderate dementia.
* Live with a PwD
* Identify as a primary caregiver for the PwD
Exclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Centre for Aging and Brain Health Innovation
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Lora Appel
Post-doc Research Fellow; Assistant Professor
Locations
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Acclaim Health
Oakville, Ontario, Canada
Circle of Care
Toronto, Ontario, Canada
Countries
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References
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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, 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Ulrich RS. View through a window may influence recovery from surgery. Science. 1984 Apr 27;224(4647):420-1. doi: 10.1126/science.6143402.
Related Links
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Other Identifiers
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VRx@Home Pilot
Identifier Type: -
Identifier Source: org_study_id
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