Virtual Reality to Advance Dementia Care and Quality of Life

VR-Care is a multi-site, investigator-initiated, single-arm feasibility study of virtual reality (VR) for adults aged 55 years and older with moderate-to-severe dementia and clinically significant agitation in inpatient geriatric psychiatry settings. The study does not include randomization, blinding, or a comparator group.

Agitation in dementia can include restlessness, pacing, repeated vocalizations, verbal aggression, physical aggression, emotional distress, or resistance to care. In inpatient care settings, agitation may be difficult to manage and can affect the person living with dementia, families, care partners, staff, and clinical workflow. Non-drug approaches are recommended in dementia care, but they can be difficult to deliver consistently in busy inpatient settings.

This study will examine whether supervised VR can be delivered safely, tolerably, acceptably, and practically in real-world inpatient geriatric psychiatry units. The primary focus is feasibility and implementation, not clinical efficacy.

Approximately 10 participants will be enrolled across two inpatient geriatric psychiatry units:

Finch Family Mental Health Care Building, St. Joseph's Health Care London; Victoria Hospital Geriatric Behavioural Unit, London Health Sciences Centre

Each participant will be followed for approximately seven weeks, when feasible, including screening, enrollment, baseline assessments, familiarization, up to six weeks of regular VR sessions, and end-of-study or early-termination assessments, as applicable.

Formal screening will begin after informed consent has been obtained from the prospective participant, if capable of consenting to this study, or from an authorized substitute decision maker, as applicable. Participant assent or behavioural willingness will be sought when applicable, and verbal or non-verbal refusal or distress will be respected throughout the study.

Screening, enrollment, baseline assessments, and familiarization will form one continuous study period. These activities may be completed on the same day or over more than one day, depending on respondent and staff availability, the participant's clinical status and readiness for familiarization, and unit workflow. There is no fixed observational or waiting period.

During screening, the study team will review the prospective participant's dementia diagnosis; relevant medical, psychiatric, neurological, behavioural, sensory, and safety history; medication use; and all other inclusion and exclusion criteria. The Cohen-Mansfield Agitation Inventory (CMAI) will be administered to document the nature and frequency of relevant agitated behaviours and to support the investigator's determination of whether the prospective participant meets the 2024 International Psychogeriatric Association definition of agitation in cognitive disorders. CMAI scores alone will not establish eligibility, and no numerical CMAI cutoff will be used. The Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) will be administered to assess behavioural and psychological symptoms and the applicable exclusion criterion concerning clinically significant delusions or hallucinations.

For participants who are eligible and enrolled, the screening CMAI and NPI-NH assessments will also serve as the corresponding baseline assessments. Remaining baseline assessments, completed after enrollment to the extent feasible, will include the proxy-rated Quality of Life in Alzheimer's Disease scale and a modified Clinical Global Impression-Severity agitation rating. Demographic, medication, and other relevant clinical and contextual information will also be documented.

Following enrollment and completion of the remaining baseline assessments to the extent feasible, every enrolled participant will be offered a brief VR familiarization or orientation procedure. Completion of tolerated familiarization is required before regular VR intervention sessions may begin. Familiarization will not constitute intervention initiation, will not count as a regular VR intervention session, and will not be included in intervention-adherence calculations. An enrolled participant who does not tolerate familiarization and does not begin a regular VR session will be classified as an enrolled non-initiator rather than a screen failure, and the reason will be documented.

Participants who tolerate familiarization may be offered up to three regular VR sessions per week for up to six weeks, with a maximum of 18 regular sessions. Regular sessions will begin at approximately 10 minutes and may gradually increase to approximately 30 minutes, as tolerated. Participants will not be required to reach the maximum session length.

VR content will be selected from the Rendever platform content library using a graded, participant-centred approach. Familiarization and early VR exposure will begin with calming, low-motion, low-stimulation, non-threatening experiences. Content may later be adjusted based on the participant's comfort, preferences, observed responses, staff or family input, clinical appropriateness, and safety considerations. Highly stimulating, fast-moving, disorienting, flashing, frightening, or otherwise distressing content will not be used.

Only a randomly assigned study identification code may be entered into the Rendever platform. Participant names, other identifying information, clinical assessment information, and participant-provided photographs, videos, or recordings will not be entered or uploaded. The study will not use the AI Guide or AI Companion, voice or audio recording or transcription, participant media-upload features, or other unused social or participant-profile features.

Trained staff will deliver VR sessions within routine inpatient care workflows, with research-team oversight. Before familiarization and every regular VR session, staff will complete a safety and readiness check and confirm the participant's willingness to proceed. Participants will remain seated during VR exposure.

Familiarization or a regular VR session will not proceed or will be stopped early if the participant shows verbal or non-verbal refusal, distress, dizziness, nausea, confusion, disorientation, worsening agitation, fear, unsafe movement, attempts to remove the headset, or any other safety concern.

For each prospectively planned regular session, the study team will document whether the session was offered, initiated, completed as tolerated, stopped early, deferred, or not conducted, together with the reason. Participant refusal, intolerance, missed or deferred sessions, interrupted sessions, and permanent discontinuation of VR will be documented as feasibility, tolerability, and session-delivery outcomes. Initiation of at least one regular VR session, including a first session that is stopped early, will constitute intervention exposure.

The Pittsburgh Agitation Scale will be completed immediately before and after each regular VR intervention session, as feasible and clinically appropriate, to describe immediate changes in agitation associated with individual sessions. Other participant assessments will be completed at the protocol-specified timepoints, including end-of-study or early-termination assessments when applicable and feasible.

Participants will continue to receive standard inpatient clinical care throughout the study. The study will not prohibit, delay, or require changes to clinically indicated medication treatment, and there are no protocol-mandated medication washouts. Medication use will be documented descriptively as contextual information.

Familiarization and regular VR sessions will ordinarily be deferred for six hours after administration of an as-needed rescue medication for acute agitation or behavioural distress. Earlier VR exposure may occur only if the treating clinical team confirms that the participant has returned to their usual state and is clinically ready, all pre-session readiness criteria are satisfied, the reason for proceeding earlier is documented, and the Principal Investigator or Co-Principal Investigator authorizes the earlier exposure.

Safety monitoring will begin after informed consent and continue throughout study participation. Safety concerns, intolerance, adverse effects, early stopping, and permanent discontinuation related to VR will be documented.

Primary outcomes are feasibility and implementation outcomes. These include recruitment and participant flow, recruitment rate, intervention initiation, participant retention, final-assessment completion, intervention completion and disposition, adherence to planned regular VR sessions, intervention tolerability, safety, session-delivery feasibility, and staff implementation outcomes. Recruitment rate will use formally eligible individuals as its denominator. Participant retention and final-assessment completion will be measured and reported separately.

Staff acceptability, appropriateness, usability, implementation feasibility, perceived workload and workflow burden, and integration into routine care will be assessed through two complementary staff-feedback pathways using three study-specific questionnaires. Appropriately trained and PI/Site PI-delegated staff who serve as VR facilitators will be invited to complete a pre-implementation expectations questionnaire and a post-implementation experience questionnaire. Eligible frontline care staff, including registered nurses (RNs), registered practical nurses (RPNs), personal support workers (PSWs), and other unit staff directly involved in participant care, who have relevant direct experience with VR-Care and were not acting in a formal VR facilitator role may complete a separate one-time experience questionnaire. Routine operational discussions or troubleshooting outside these questionnaires will not be analyzed as staff-feedback research data.

Exploratory outcomes will describe agitation over time using standard CMAI frequency ratings, the perceived disruptiveness of agitated behaviours using CMAI disruptiveness ratings, immediate pre- to post-session agitation, broader behavioural and psychological symptoms, quality of life, clinician-rated global agitation severity, NPI-NH occupational disruptiveness, and medication-use patterns. These outcomes will be interpreted descriptively and cautiously because the study is small, single-arm, and not powered to establish clinical efficacy.

Findings from this study will be used to refine study procedures, safety monitoring, intervention delivery, staff training, outcome selection, and feasibility benchmarks for a future larger controlled trial.