A single site case series.
Older adults (aged ≥ 65 years) residing in a LTC home at London ON Canada with a Cognitive Performance Scale (CPS) score between 3 to 5 and exhibiting at least one BPSD were eligible to participate in this study. Ontario LTC homes regularly evaluate their residents’ cognition with CPS score . The CPS 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 CPS scale . A CPS 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-Maker (SDM) appointed as Public Guardian and Trustee.
One LTC home staff member identified the possible participants using their CPS score. Once identified, the LTC home staff spoke with participants’ SDM face-to-face or by phone to learn if the SDM would agree to be contacted for a possible study participation. Once agreed, we (KC, Research Assistant [RA]) contacted the SDM 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. RA selected the library items for each. If a participant preferred a particular library item, the RA 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. RA 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 LTC home staff also were on call during the VR sessions in case of any unforeseen adverse events.
We provided the intervention at the LTC 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 LTC 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 LTC 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 (AE) during the intervention period, health care resources used (i.e. the number of participants requiring transfers to emergency, number of participants requiring one-to-one staff use, psychotropic drug prescription), and change in Euro-Qol 5-Dimention [EQ-5D]) 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 staff members’ experience with the participating LTC home 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 AE 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, transfers to emergency and one-to-one staff usage indicated acute decline or worsening of a participant’s health. For instance, the LTC 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 EQ-5D 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 the SDM was present during the VR sessions, and factors that were observed to be enabling or disabling during the VR experience.
Change in participants’ BPSD. 1) We collected the pre-to post (before any VR intervention took place [baseline] and at the end of second week of intervention) change of BPSD and reported the BPSD measuring instruments’ sensitivity to change with ES. Sensitivity to change of a tool is its ability to detect change (signal over noise) regardless of whether the change is meaningful to the clinician or decision maker . The most appropriate statistic for sensitivity to change remains a matter of debate . Usually, for a single group index, sensitivity to change is reported using effect size (ES) . ES analysis is based on the assumption that the participants are homogenous at the baseline and may exhibit a change by approximately the same amount over the study period . ES is expressed using a ratio of mean change scores (𝛿x=x2- x1) to the Standard Deviation (SD) of the baseline scores .If change has occurred, ES value greater than 1 indicates that the instrument is sensitive to change . As ES can determine the sample size  and can facilitate comparison between studies in meta-analyses , we selected ES to report the sensitivity to change for this study.
BPSD are usually measured with subjective psychometric tools, originally developed to rate feelings or opinions or attitudes . A systematic review located 83 BPSD tools focusing either on depression (n=46) or irritability (n=37) or non-aggressive agitation (n=26) or anxiety (n=22) or hallucination (n=21) or delusion (n=20) or wandering (n=22) or apathy (n=17) or sleep problems (n=14) . According to Linde and colleagues , the frequently used BPSD tools for older adults in clinical settings are the Cambridge Mental Disorders of the Elderly Examination (CAMDEX) , the Geriatric Mental State Schedule (GMS)/Automated Geriatric Examination for Computer Assisted Taxonomy (AGECAT) , the Apathy Evaluation Scale (AES) , the Geriatric Depression Screening scale (GDS) , the Neuro Psychiatric Inventory (NPI) , Cornell Scale for Depression in Dementia (CSDD) , and Cohen-Mansfield Agitation Inventory (CMAI).
For this study, we used CSDD, CMAI, proportion of night-time sleep, and Dementia Observation System (DOS) scale  to measure participants’ BPSD. Our null hypothesis was that VR experience had no effect on participants’ BPSD. We selected CSDD as it is feasible for those with advanced dementia  and CMAI as it is applicable for LTC residents . Since Henley Place routinely records residents’ night-time sleep as a proportion of the total expected asleep time (8 hours, from 10:00 pm to 6:00 am each night), we opted to measure sleep using methods already in place. We selected DOS as it is designed to be completed by LTC staff members .
The 19-item CSDD detects depression in dementia, and includes five domains: mood, behaviour, physical signs, cyclic function, and ideation, from interviews with a caregiver . Each item is rated for severity based on symptoms occurring during the week before the interview on a scale of 0-2 where 0 indicates no symptoms and 2 indicates severe symptoms .The interrater reliability (k=0.67) and internal consistency (α=0.84) of the instrument is high . The association between CSDD and Research Diagnostic Criteria Depression  (a scale measuring similar construct) also is strong (r=0.83, p < 0.001) .
The 29-item CMAI tool assesses the agitated behaviours within four components: 1) Physical Aggressive (PA), 2) Physical Non-Aggressive (PNA), 3) Verbal Aggressive (VA), and 4) Verbal Non-Aggressive (VNA) . Each behaviour is rated on a 7-point scale of frequency, ranging from the resident never manifesting the behaviour (1) to manifesting the behaviour several times an hour (7). The scale is reliable (test-retest reliability coefficient=0.830; p<0.001)  in individuals with dementia and has demonstrated construct validity (i.e. strong association with Agitated Behaviour in Dementia, r=0.62; p<0.001) .
Sleep disturbance (e.g. difficulty falling asleep, repetitive sleep awakenings, and waking up early) is a risk factor for developing depressive symptoms , apathy , and aggressiveness  in dementia. Individuals with sleep problems had a higher risk of Alzheimer’s disease (Risk ratio [RR]=1.55, 95% CI 1.25 to1.93), cognitive impairment (RR=1.65, 95% CI, 1.45 to1.86), and preclinical Alzheimer’s disease (RR=3.78, 95% CI: 2.27–6.30 than individuals without sleep problems . The association between sleep disturbance with Pittsburgh Sleep Quality Index  and NPI-Apathy domain is moderate (r=0.38; p<0.01) . Thus, proportion of night-time sleep indirectly predicts BPSD .
DOS evaluates objective and accurate data about an individual’s behaviour throughout each 24-hour cycle over a period of five consecutive days to identify patterns, trends, contributing factors and modifiable variables associated with BPSD . The rater records a maximum of five observed behaviours (sleeping, awake/calm, positively engaged, repetitive vocal and motor expressions, and sexual/ verbal/physical expression of risk) based on his/her judgement every half an hour for five days and colour codes the observed behaviours .
We did not select CAMDEX and GMS/AGECAT for our pilot as they are predominantly diagnostic tools, irrelevant to our objective. We also did not select AES and GDS as they are self-reported, which is not suitable for our participants. Even though the NPI is a validated clinical tool designed explicitly to provide a comprehensive evaluation of BPSD , raters' tight work schedule can deviate the original NPI protocol (e.g., an arbitrary evaluation of symptoms is made based on the general domains instead of using sub-questions)  or can lead to a possible recall bias (e.g. rating is based on retrospective information [one month]) [74, 75]. Considering tight work schedule of LTC staff members and possible recall bias, we did not select NPI.
2) We measured the association of pre-to post change BPSD scores between week 1 and pre-intervention and again between week 2 and week 1 for the CSDD and CMAI with the Global Rating of Change (GRC) scale  and reported the association with Pearson’s r (rho) or coefficient r.
The GRC scale captures an individual’s perspective (in this case, participants’ caregivers) regarding their change in health condition (in this case, depression and agitation) . The scale quantifies the change (from a small, unimportant change to a very great deal of change) using scores 0 to 7 (0=no change, +1 to +7= a perceived improvement in condition, and -1 to -7= a perceived deterioration in condition) . We classified GRC as a lot worse (GRC=-7,-6), moderately worse (GRC=-4, -5), minimally worse (GRC=-1, -2, -3), stable (GRC=0), minimally better (GRC=1, 2, 3), moderately better (GRC=4, 5), and a lot better (GRC=6, 7).
To demonstrate the association, we expected that a GRC rating of 0 would be associated with little to no change in the CSDD/CMAI (i.e. a change score of 0). Considering the short period of intervention (two weeks), we did not expect many participants to experience very large changes, thereby reducing the breadth of the scale and reducing the magnitude of the association. Thus, our a priori hypothesis for the correlation between CSDD/CMAI and GRC was weak to moderate. The categorization of the strength of correlation using coefficient r was strong when r ≥0.6, moderate when r=0.3 to 0.6, and weak when r ≤0.3 .
Data collection. KC and RA 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 AE forms, archived the number of emergency transfers, 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.
We invited the SDM to complete the CSDD, CMAI, and DOS scale. However, the SDM felt that the LTC staff could more accurately complete these tools since they provide care for the residents 24/7. One of us (KC) trained the LTC staff caregivers to complete the above-mentioned tools. LTC staff caregivers completed CSDD, CMAI, DOS, and EQ-5D 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 SDM willing to provide consent to participate in the trial from the LTC home (192 bed capacity). The reason for our low estimate was that attempts to contact the SDM were to take place during Holiday season (Christmas and New Year), which did not optimize access. To maximize the recruitment, RA contacted SDM on weekdays from 9 to 5 and kept the study phone open on evenings and weekends for them to call back. The RA also went into the LTC home after hours to meet SDM in the evenings and weekends. Given this estimate, to be 95% confident we needed 18-27 eligible participants (and their SDM) in the population to provide consent .