Supporting Unpaid Caregivers of Persons Living With Dementia: Protocol for a Pilot Feasibility Study to Explore Caregiver Outcomes and Impact of a Co-Designed Simulation-Based Psychoeducation Program in Virtual Reality.

内容摘要

Dementia is a global public health concern, with prevalence projected to reach 78 million individuals by 2030 and 139 million by 2050. Most persons living with dementia reside in community settings and are supported by family caregivers. As caregiving demands grow, caregivers experience significant psychosocial, emotional, and financial burden, including high rates of stress, social isolation, and depressive symptoms. Access to effective support services remains limited, highlighting the urgent need for innovative and accessible caregiver interventions. This pilot study first aims to assess the feasibility, acceptability, and tolerability of VR-SIM Carers, a virtual reality (VR)-based psychoeducational training program for family caregivers or care partners of people living with dementia. Second, it will aim to provide a preliminary evaluation of potential impact on caregiver outcomes, including caregiver competence, stress, resilience, empathy, and quality of life. The study is not designed to support causal inference regarding the effectiveness of VR-SIM Carers. A mixed methods design will be used with a sample of 30 family caregivers of people living with dementia. Participants will complete 3 immersive, self-paced VR caregiving scenarios-Managing Apathy, Crisis Response, and Refusal of Care-receiving real-time feedback from simulated characters, including clinician and person living with dementia avatars. Primary outcomes (feasibility and educational impact) include recruitment, retention, adherence, usability, acceptability, and tolerability and caregiver competence (Pearlin Caregiving Competence Scale), perceived stress (Cohen Perceived Stress Scale), resilience (Connor-Davidson Resilience Scale), and empathy (Empathy Assessment Scale). Secondary outcomes (preliminary efficacy) include caregiver quality of life (Adult Carer Quality of Life Questionnaire), caregiver burden (Burden Questionnaire), and behavioral symptoms (Neuropsychiatric Inventory, Center for Epidemiologic Studies Depression Scale Short Form) assessed at baseline, postintervention, and 1-month follow-up. Feasibility and user engagement will be evaluated via the 18-item Gaming Use Engagement and Severity Scale, Igroup Presence Questionnaire, qualitative interviews, reflection notes, and open-ended feedback. Quantitative data will be analyzed using repeated-measures ANOVA and paired 2-tailed t tests, while qualitative data will be analyzed using an inductive thematic coding framework. Data analyses are descriptive and exploratory only, and no causal claims regarding intervention effectiveness will be made. Consistent with CONSORT (Consolidated Standards of Reporting Trials) guidance for pilot and feasibility studies, caregiver outcomes (eg, competence, stress, resilience, empathy) are treated as exploratory. The findings from this study will inform the feasibility, acceptability, and educational value of immersive VR for caregiver training, while providing preliminary evidence regarding the efficacy of VR-SIM Carers as a training tool to improve psychoeducation outcomes for family caregivers of people living with dementia and reduce caregiving burden. Data collection commenced in March 2024 with a projected end date of March 2026. As of the submission of the manuscript (December 2025), 21 participants have been enrolled. Data analysis will be completed in April 2026, and the results are expected to be published in fall 2026. VR-SIM Carers represents an innovative, scalable intervention designed to enhance caregiver preparedness, psychosocial outcomes, and sustainable community-based dementia care. This pilot study will provide critical evidence to guide further development and implementation of VR-based caregiver support programs.