Virtual Reality to Advance Dementia Care and Quality of Life

Registry record from ClinicalTrials.gov (NCT07893678). This is a study registration, not published results. Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 10 participants (ESTIMATED). Conditions: Dementia, Agitation, Behavioural and Psychological Symptoms of Dementia, Major Neurocognitive Disorder, Agitation Aggression in Dementia. Interventions: BEHAVIORAL: Supervised Virtual Reality Sessions. Primary outcome measures: Recruitment feasibility and recruitment rate , From start of recruitment through completion of enrollment, anticipated up to approximately 14 months; Participant retention rate , From enrollment through the planned end-of-study timepoint, up to approximately 7 weeks per participant; Intervention initiation rate , From enrollment through the first regular VR intervention session or determination of non-initiation, anticipated within approximately 2 weeks per participant; Intervention adherence and session completion , During the VR intervention period, up to approximately 6 weeks; Session-delivery feasibility , During the VR intervention period, up to approximately 6 weeks; Intervention completion and disposition , From enrollment through end-of-study or early termination, up to approximately 7 weeks per participant; Intervention tolerability , During the VR intervention period, up to approximately 6 weeks; Safety and session-level tolerability events , From informed consent through end-of-study or early termination, up to approximately 7 weeks per enrolled participant; Staff acceptability, appropriateness, usability, implementation feasibility, perceived workload and workflow burden, and workflow integration , From completion of facilitator training/orientation through the end of relevant staff involvement or intervention delivery, through study completion, anticipated up to approximately 15 months; Final-assessment completion rate , From enrollment through end-of-study or early termination, up to approximately 7 weeks per participant. Brief summary: The goal of this feasibility clinical trial is to learn whether supervised virtual reality (VR) sessions can be safely and practically provided to adults aged 55 years and older with moderate-to-severe dementia who experience agitation while receiving care in inpatient geriatric psychiatry units. The main questions this study aims to answer are: Can participants be identified, enrolled, and retained in the study? Can participants tolerate and complete supervised VR sessions? Can clinical staff fit VR sessions into routine inpatient care? What safety or comfort concerns occur during or after VR sessions? Can the study team collect information needed to plan a larger future study? Following informed consent, prospective participants will undergo screening to determine eligibility. Those who are eligible and enrolled will complete any remaining baseline assessments and will then be offered a brief VR familiarization or orientation procedure. Completion of tolerated familiarization is required before regular VR sessions may begin. Familiarization will not count as intervention initiation or as a regular VR intervention session. These activities form one continuous study period; there is no fixed observational or waiting period. Participants who tolerate familiarization may be offered supervised VR sessions up to three times per week for up to six weeks, with a maximum of 18 regular sessions. Sessions will start at about 10 minutes and may increase gradually to about 30 minutes, depending on each participant's comfort and tolerance. Familiarization and early VR exposure will begin with calming, low-stimulation, non-threatening virtual environments. Content may later be adjusted based on the participant's comfort, preferences, observed response, clinical appropriateness, and safety. Participants will remain seated and will be monitored by trained staff. Sessions will not start or will be stopped if the participant shows distress, discomfort, refusal, dizziness, nausea, confusion, worsening agitation, or any other safety concern. Researchers will also collect information about agitation, behavioural symptoms, quality of life, medication use, staff experience, and workflow. This study is not designed to prove that VR treats agitation or dementia. The findings will be used to determine whether a larger future study is practical and how it should be designed.