A single site case series.
Older adults (aged ≥ 65 years) residing in a care home at London ON Canada with a Cognitive Performance Scale score between 3 to 5 and exhibiting at least one BPSD were eligible to participate in this study. Ontario long-term care homes regularly evaluate their residents’ cognition with Cognitive Performance Scale score . The scale includes four areas: memory, decision-making skills, communication and eating . Residents experiencing no difficulties in these four areas score 0, whereas residents having severe memory problems and are unable to make daily decisions or feed themselves or are comatose score 6 on the scale . A Cognitive Performance Scale score 0 indicates no dementia, whereas a score of 1-2 indicates mild, score of 3 indicates moderate, and score of 4-6 indicates severe dementia . We excluded those diagnosed with epilepsy, those who were blind, at end of life, and unable to communicate in English. We also excluded those having substitute decision-makers appointed as Public Guardian and Trustee.
One care home staff member identified the possible participants using their Cognitive Performance Scale score. Once identified, the care home staff spoke with participants’ substitute decision-makers face-to-face or by phone to learn if the they would agree to be contacted for a possible study participation. Once agreed, we (KC, Research Assistant) contacted the substitute decision-makers from November 26, 2018 to January 04, 2019 to recruit participants.
The intervention was VR experience using BroomX© technology, introduced in 2017 . The technology uses a MK Player360© hardware and a software . A MK Player360© is a projection device with light and sound control that can provide an immersive experience covering the user’s field of vision (180° horizontal view x 120° vertical view) with full high definition resolution . The software provides customized interactive visual and auditory experience accessed by a smartphone app (See Figure 1: Technical information on Broomx©) . The family members informed us about participants’ leisure activities, objects of attention, preferences for musical instruments, genres of music, images of nature, and urban scenes. One of us (ASG from Crosswater Digital Media [https://crosswater.net/]) customized the multimedia content of BroomX© smartphone app accordingly and created a multimedia library with pleasing images of nature, set to music (72 beats/minute) for this study.
The maximum duration and frequency of the VR experience (intervention) was 30 minutes, five days a week (Monday to Friday) for two weeks. The timing of the intervention was customized for each participant to avoid their usual lunch time, visiting hours, and nap time. However, the two-week intervention schedule was fixed for the convenience of the project. If a participant missed the intervention for the day for any reason, there was no makeup session on a different day. Research Assistant selected the library items for each. If a participant preferred a particular library item, the Research Assistant selected that item several times. There was no limit to the frequency or variety of the played library items.
For safety concern, we stopped the intervention if a participant became agitated with a specific VR library item. Research Assistant was present inside the intervention area during the VR sessions in case the participant needed assistance with postural balance and thus reduced the risk of falls. The care home staff also were on call during the VR sessions in case of any unforeseen adverse events.
We provided the intervention at the care home from November 2018-January 2019.The VR experience was provided using a headset at the beginning of the intervention (November 5-9, 2018) to five participants. We noticed that all five participants felt uncomfortable using the headset as it limited their vision, was too loud, and was heavy. The pilot study was conducted during Ontario flu season. We were obliged to disinfect the headset after each use with a disinfecting liquid, challenging our time management. We did not use headset from then on.
During the second week of the intervention period (November 12-16, 2018), we carried the MK Player360© projector to the participants’ own rooms. We plugged the electrical cord from the projector into a working electrical outlet, kept the projector in a vertical position, and used care home’s Wi-Fi connection to pair the devise with study smartphone. We covered TV with bed sheet, brought down any wall hangings, closed windows and door curtains for a clearer visualization of VR images when setting up MK Player360© projector inside a participant’s room. Two participants got agitated when setting up the hardware and software in their own rooms. Our time management also was challenged when assembling/disassembling VR hardware at participant’s own room. From that time forward, we assembled MK Player360© projector in a pre-determined area inside the care home before starting the VR sessions to accommodate participants’ discomfort and practicality of time management.
Outcome Measures and Statistical Methods
Feasibility of VR experience. 1) The rate of recruitment (the proportion of consenting participants to eligible participants over the 6-week recruitment period), adherence (the proportion of participants attending 10 intervention sessions to the number of participants allocated to the intervention) and attrition (the proportion of participants completing the study to the number of participants allocated to intervention).
2) Participants’ tolerance for the VR with measures such as the proportion of participants who were able to tolerate at least 80% of the planned sessions, the mean length of participants’ VR experience in minutes per session, number of times each type of negative behaviour observed and the proportion of participants who experienced each negative behaviour, number of times each type of positive behaviour was observed and the proportion of participants who experienced each positive behaviour, number of adverse events during the intervention period, health care resources used (i.e. number of participants requiring one-to-one staff use, psychotropic drug prescription), and change in Euro-Qol 5-Dimention) to indirectly indicate their tolerance to VR experience.
According to the Need Driven Behaviour Model , an individual with dementia expresses his/her physical/emotional needs or exhibits his/her dementia symptoms through physical/verbal expressions/gestures. Following this model, we labelled the following behaviours as “negative” for this pilot study: agitation, wandering, hitting (including self), kicking, grabbing onto people, pushing, throwing objects, biting, scratching, spitting, hurting self or others, tearing objects or destroying property, making physical/verbal sexual advances, inappropriate dressing or disrobing, intentional falling, eating/drinking inappropriate substance, handling objects inappropriately, hiding objects, hoarding objects, performing repetitive mannerisms, screaming, cursing or verbal aggression, repetitive sentences or questions, strange noises (weird laughter or crying), complaining, constant unwarranted request for attention or help, pulling away/walking away, perseveration of word/repetitive talking, raising tone of voice, resisting, and not eating. We labeled the following behaviours as “positive” based on Henley Place staff members’ experience with the participating residents for this pilot study: being seated still, being focused, sleeping better than usual during nigh time, being calm, smiling, and communicating verbally/non-verbally.
We defined an adverse event as any event due to being in a VR session leading to emergency transfer, hospitalization, death, a persistent or significant incapacity or substantial disruption of the participants’ ability to conduct the activities of daily living following Code of Federal Regulations .
In our judgement, one-to-one staff usage indicated acute decline or worsening of a participant’s health. For instance, the care home may provide a participant one-to-one staffing if he/she causes another individual a physical incident or a sexual incident; becomes physically aggressive (non-manageable) with drug and other therapy; has history of a similar behaviour that ended up on having one-to-one staff usage in the recent past; is in risk of potential self-harm; exhibits an agitated aggressive behaviour or a wandering behaviour; and is at risk of being victimized by another individual. Psychotropic drugs refer to any drug affecting mental processes and behaviour . Psychotropic drugs include, but are not limited to, antipsychotics, antidepressants, antianxiety drugs, mood stabilizers, anticonvulsants, and hypnotics . The Euro-Qol 5-Dimention scale is a generic quality of life tool, insightful in identifying which dimensions of health are most affected by a given condition or treatment . The tool has five domains: mobility, self-care, usual activities (e.g. work, study, housework, family or leisure activities), pain/discomfort, and anxiety/depression with five possible answers for each domain (1=no problem, 2=slight problem, 3=moderate problem, 4=severe problem, 5=unable to do/extreme problem) .
3) Facilitators and barriers to implementation of VR included data on the number of times a library item was selected, whether a substitute decision-maker was present during the VR sessions, and factors that were observed to be enabling or disabling during the VR experience.
Data collection. KC and Research Assistant used electronic data capture forms to record the number of participants contacted, consented, completed VR sessions; labelled participants’ behaviours during the VR sessions based on direct observation; completed adverse event forms, archived the number of one-to-one staff usage, proportion of night-time sleep, and psychotropic drug prescription at baseline, at the end of first week, and at the end of second week of intervention from the participant’s medical chart. The care home staff caregivers completed the Euro-Qol 5-Dimention at baseline, at the end of first week, and at the end of second week of intervention.
We felt that approximately 40% of participants would be eligible and have an substitute decision-maker willing to provide consent to participate in the trial from the care home (192 bed capacity). The reason for our low estimate was that attempts to contact the substitute decision-makers were to take place during Holiday season (Christmas and New Year), which did not optimize access. To maximize the recruitment, Research Assistant contacted substitute decision-makers on weekdays from 9 to 5 and kept the study phone open on evenings and weekends for them to call back. Research Assistant also went into the care home after hours to meet substitute decision-makers in the evenings and weekends. Given this estimate, to be 95% confident we needed 18-27 eligible participants (and their substitute decision-makers) in the population to provide consent .