DementiaVRx@HomeNCT04988360
VRx@Home: Study to Evaluate VR-therapy for PwD Living at Home
A study testing HMD: Immersive VR and Tablet: Non-immersive VR in people with Dementia, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- HMD: Immersive VR and Tablet: Non-immersive VR
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesCanada
- Study dates
- 10 May 2022to 17 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
PwD inclusion criteria:
- Individuals who are 65 years of age or older.
- Individuals living at home with a family caregiver.
- Individuals diagnosed with mild to moderate dementia.
PwD exclusion criteria:
- 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
Caregiver inclusion criteria:
- Live with a PwD
- Identify as a primary caregiver for the PwD
Caregiver exclusion criteria:
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Acclaim Health
Oakville, Ontario, L6L 5M2
Circle of Care
Toronto, Ontario, M2P 2A9
About this study
Official title: VRx@Home: Pilot RCT to Evaluate the Effectiveness of Immersive Virtual Reality Therapy on People With Dementia Living at Home
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).
Read the detailed description
This pilot trial will be a mixed-methods, parallel arm RCT with a target total recruitment of 30 participants (15 dyads of PwD and caregivers). Each dyad will participate in the study for a total of 4 weeks.
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
- Dementia
- Being tested
- HMD: Immersive VR, Tablet: Non-immersive VR
- Keywords
- Virtual Reality, Tablets, Interpersonal Relations, Community Health Services, Apathy, Depressive Symptoms, Behavioral Symptoms, Quality of Life, Caregivers, Spouse Caregivers, Family Caregivers
- Medical subject headings
- Dementia, Lethargy, Depression, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMD: Immersive VRDevice
Also called Head-mounted display, Headset
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 VRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: HMD: Immersive VR; Device: Tablet: Non-immersive VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 28 of participation
Secondary outcomes (12)
Change from baseline perceived relationship quality within the participant dyad scores
The Dyadic Relationship Scale (DRS) will be completed by both participants (caregiver and person with dementia) to evaluate the perceived quality of the dyad relationship. The DRS is an 11-item questionnaire employing 4-point Likert scales. The DRS contains two subscales: Positive Dyadic Interaction and Dyadic Strain. Scores for the Positive Dyadic Interaction subscale range from 6-24, where higher scores indicate more positive dyadic interaction. Scores for the Dyadic Strain subscale range from 5-20, where higher scores indicate higher levels of dyadic strain.
Measured: Days 1, 14, and 28 of participation
Change from baseline apathy scores in participants with dementia
The Apathy Evaluation Scale (AES) and will be completed by both participants (caregiver and person with dementia) to determine convergence/divergence of scores. The AES is an 18-item questionnaire employing 4-point Likert scales. Scores range from 18-72. Higher scores indicate more apathy.
Measured: Days 1, 14, and 28 of participation
Change from baseline depression scores in participants with dementia
The Depression Cornell Scale for Depression in Dementia (CSDD) and will be completed by caregiver-participants. The CSDD is a 19-item questionnaire employing 3-point Likert scales and an "unable to evaluate" option. Scores range from 0-38. Higher scores indicate greater signs of depression.
Measured: Days 1, 14, and 28 of participation
Change from baseline depression scores in participants with dementia
The Short Geriatric Depression Scale (GDS) and will be completed by participants with dementia. The GDS is a 15-item questionnaire employing "yes/no" options that may be used with older adults with mild to moderate cognitive impairment. Scores range from 0-15. Higher scores indicate greater signs of depression.
Measured: Days 1, 14, and 28 of participation
Change from baseline behavioural disturbance scores in participants with dementia
Behavioural symptoms related to cognition, functional autonomy, somatic symptoms, and psychiatric symptoms displayed by participants with dementia will be evaluated by the Dementia Behaviour Disturbance Scale (DBD) which will be completed by caregiver-participants. The DBD is a 28-item questionnaire employing 5-point Likert scales. Scores range from 0-112. Higher scores indicate greater behavioural disturbance.
Measured: Days 1, 14, and 28 of participation
Change from baseline quality of life (QoL) scores for participants with dementia as assessed by the BASQID.
The Bath Assessment of Subjective Quality of Life in Dementia (BASQID) will be administered to evaluate the subjective quality of life of participants with dementia. The BASQID is a 14-item questionnaire employing 5-point Likert scales and contains two subscales Life Satisfaction (LS) and Feelings of Positive Quality of Life (FPQ) . Calculated scores range from 0-100. Higher scores indicate greater subjective quality of life.
Measured: Days 1, 14, and 28 of participation
Change from baseline quality of life (QoL) scores for participants with dementia and caregiver-participants as assessed by the QoL-AD
The Quality of Life in Alzheimer's Dementia (QoL-AD) will be administered to participants with dementia and caregiver-participants to evaluate subjective quality of life. The QoL-AD is a 13-item questionnaire employing 4-point Likert scales. Calculated scores range from 0-52. Higher scores indicate greater subjective quality of life.
Measured: Days 1, 14, and 28 of participation
Change from baseline wellbeing scores for participants with dementia and caregiver-participants as assessed by the WHO (Five) Well-Being Index
The WHO (Five) Well-Being Index will be administered to participants with dementia and 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.
Measured: Days 1, 14, and 28 of participation
Change from baseline quality of life (QoL) scores for caregiver-participants as assessed by the Caregiver Self-Assessment Questionnaire
The Caregiver Self-Assessment Questionnaire will be completed by caregiver-participants and will be used to evaluate the subjective quality of life (QoL) of caregiver-participants. This scale contains 16 "Yes/No" questions and 2 visual analog scales (VAS) ranging from 1-10. Total scores range from 2-36. Higher scores indicate lower subjective caregiver quality of life.
Measured: Days 1, 14, and 28 of participation
Change from baseline quality of life (QoL) scores for caregiver-participants as assessed by the CarerQoL-7D and CarerQoL-VAS
The CarerQoL-7D (CarerQol instrument which measures the impact of informal care on seven important burden dimensions and values this in terms of general quality of life, and the CarerQoL-VAS (Visual Analog Scale) will be completed by caregiver-participants and will be used to evaluate the subjective quality of life (QoL) of caregiver-participants. The CarerQoL-7D is a 7-item questionnaire employing 3-point Likert scales that provides a comprehensive description of the caregiving situation. The CarerQoL-VAS is a VAS ranging from 0-10 that provides a valuation of informal care in terms of well-being. The CarerQoL-VAS is an optional addition to the CarerQoL-7D and is not used when calculating scores. Calculated QoL scores range from 0-100 where higher scores indicate better caregiving situations.
Measured: Days 1, 14, and 28 of participation
Change from baseline feelings of caregiver reward for caregiver-participants
The Positive Aspects of Caregiving (PAC) tool will be completed by caregiver-participants and will be used to evaluate subjective positive feelings associated with being a caregiver for the person with dementia. The PAC is a 9-item questionnaire that measures feelings of reward in Alzheimer's caregiving and has two subcomponents: self affirmation and outlook on life. Total scores range from 9-45 where higher scores indicate greater feelings of caregiver reward.
Measured: Days 1, 14, and 28 of participation
Change from baseline feelings of caregiver burden for caregiver-participants
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.
Measured: Days 1, 14, and 28 of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start10 May 2022
- Primary completion17 Sep 2022
- Study completion17 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation
- Responsible party
- Principal investigator, Lora Appel, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988360
- Sponsor's protocol ID
- VRx@Home Pilot
- Acronym
- VRx@Home
- Status last verified
- Oct 2022
- First submitted
- 21 Jun 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32010701Appel 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.
PubMed 33292729Appel 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.
PubMed 33533720Berman 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.
PubMed 22464936Brodaty 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.
PubMed 19585957Diette 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.
PubMed 12628899Hughes 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.
PubMed 12386013Morita 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.
PubMed 17055544Park 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.
PubMed 19568835Park 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.
PubMed 19715461Posch M, Bauer P, Brannath W. Issues in designing flexible trials. Stat Med. 2003 Mar 30;22(6):953-69. doi: 10.1002/sim.1455.
PubMed 12627412Robinson 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.
PubMed 16849002Ulrich RS. View through a window may influence recovery from surgery. Science. 1984 Apr 27;224(4647):420-1. doi: 10.1126/science.6143402.
PubMed 6143402
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRx@Home: Pilot RCT to Evaluate the Effectiveness of Immersive Virtual Reality Therapy on People With Dementia Living at Home
- ClinicalTrials.gov ID
- NCT04988360
- Acronym / sponsor ID
- VRx@Home / VRx@Home Pilot
- Conditions
- Dementia
- Keywords
- Virtual Reality, Tablets, Interpersonal Relations, Community Health Services, Apathy, Depressive Symptoms, Behavioral Symptoms, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation
- Study start
- 10 May 2022 (actual)
- Primary completion
- 17 Sep 2022 (actual)
- Study completion
- 17 Sep 2022 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This pilot trial will be a mixed-methods, parallel arm RCT with a target total recruitment of 30 participants (15 dyads of PwD and caregivers). Each dyad will participate in the study for a total of 4 weeks.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: HMD first | Experimental | Device: HMD: Immersive VR, Device: Tablet: Non-immersive VRThose 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. |
| Group B: Tablet first | Experimental | Device: HMD: Immersive VR, Device: Tablet: Non-immersive VRThose 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMD: Immersive VRAlso: Head-mounted display, HeadsetParticipants 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. | Device | Group A: HMD first, Group B: Tablet first |
| Tablet: Non-immersive VRParticipants 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. | Device | Group A: HMD first, Group B: Tablet first |
Primary outcome
Usability scores of first VR intervention used
Time frame: Day 14 of participation
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.
Usability scores of second VR intervention used
Time frame: Day 28 of participation
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.
Appropriateness of the study procedures for feasible use of VR-therapy in the home using first intervention
Time frame: Day 14 of participation
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.
Appropriateness of the study procedures for feasible use of VR-therapy in the home using second intervention
Time frame: Day 28 of participation
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.
12 secondary outcomes
Change from baseline perceived relationship quality within the participant dyad scores
Time frame: Days 1, 14, and 28 of participation
Change from baseline apathy scores in participants with dementia
Time frame: Days 1, 14, and 28 of participation
Change from baseline depression scores in participants with dementia
Time frame: Days 1, 14, and 28 of participation
Change from baseline depression scores in participants with dementia
Time frame: Days 1, 14, and 28 of participation
Change from baseline behavioural disturbance scores in participants with dementia
Time frame: Days 1, 14, and 28 of participation
Change from baseline quality of life (QoL) scores for participants with dementia as assessed by the BASQID.
Time frame: Days 1, 14, and 28 of participation
Change from baseline quality of life (QoL) scores for participants with dementia and caregiver-participants as assessed by the QoL-AD
Time frame: Days 1, 14, and 28 of participation
Change from baseline wellbeing scores for participants with dementia and caregiver-participants as assessed by the WHO (Five) Well-Being Index
Time frame: Days 1, 14, and 28 of participation
Change from baseline quality of life (QoL) scores for caregiver-participants as assessed by the Caregiver Self-Assessment Questionnaire
Time frame: Days 1, 14, and 28 of participation
Change from baseline quality of life (QoL) scores for caregiver-participants as assessed by the CarerQoL-7D and CarerQoL-VAS
Time frame: Days 1, 14, and 28 of participation
Change from baseline feelings of caregiver reward for caregiver-participants
Time frame: Days 1, 14, and 28 of participation
Change from baseline feelings of caregiver burden for caregiver-participants
Time frame: Days 1, 14, and 28 of participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Background: PubMed 32010701Appel 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.
- Background: PubMed 33292729Appel 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.
- Background: PubMed 33533720Appel 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.
- Background: PubMed 22464936Berman 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.
- Background: PubMed 19585957Brodaty 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.
- Background: PubMed 12628899Diette 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.
- Background: PubMed 12386013Hughes 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.
- Background: PubMed 17055544Morita 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.
- Background: PubMed 19568835Park 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.
- Background: PubMed 19715461Park 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.
- Background: PubMed 12627412Posch M, Bauer P, Brannath W. Issues in designing flexible trials. Stat Med. 2003 Mar 30;22(6):953-69. doi: 10.1002/sim.1455.
- Background: PubMed 16849002Robinson 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.
- Virtual Reality Aimed At The Elderly Finds New FansLink provided by the sponsor.
- People with dementia test-drive virtual reality rehabilitation system used by injured soldiers to help their conditionLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMD: Immersive VR and Tablet: Non-immersive VR in people with Dementia, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability scores of first VR intervention used (time frame: Day 14 of participation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988360, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.