About this trial
The goal of this study is to examine the effectiveness of VR-based respite in improving cognitive function, mental health, and quality of life in caregivers and homebound older adults compared to a control group using videos and a usual care group. Participants are randomly assigned to one of three groups: VR intervention, video control, or usual care.
The VR group receives immersive VR sessions using the SilVR Adventures platform. The video group receives non-immersive video sessions with similar content. The usual care group receives no additional intervention.
Assessments are conducted at baseline, immediate post-intervention, and 3 months post-intervention to measure changes in depression, anxiety, loneliness, quality of life, and other outcomes. The intervention dosage will be 4 weeks (1 sessions/week; 30 min/session).
Secondarily, the study explores differences in effectiveness between caregivers and homebound older adults, and potential moderators or mediators such as baseline health status, technological literacy, and social support.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 or above
Provide care to at least one homebound older adult (aged 60 or above)
Provide no less than 6 hours of caregiving per week
Able to communicate in either Cantonese, Mandarin or English
Disqualifiers
History of severe psychiatric disorders (e.g., schizophrenia, bipolar)
Severe cognitive impairment (MMSE <10)
Major neurological diseases (e.g., recent stroke, severe Parkinson's)
Uncorrectable visual/hearing impairments affecting VR/video
Trial design
Parallel
Treatments tested in this trial
VR-based Respite
DeviceCaregivers and homebound older adults will receive 4 weeks of VR-based respite sessions. 4 weeks (1 session/week; 30 min/session) of immersive VR sessions using SilVR Adventures platform. Sessions include virtual travel destinations (e.g., cities, natural wonders) and social activities (e.g., group tours). Facilitated by trained research staff, with 5-10 minutes viewing and 20 minutes reflection/discussion.
Video-based Respite
DeviceCaregivers and homebound older adults will receive 4 weeks of video-based respite sessions. 4 weeks (1 session/week; 30 min/session) of non-immersive video sessions with content similar to VR themes (e.g., landscapes, cultural events). Facilitated by trained research staff, with post-video discussion. EEG data collected during viewing to assess emotional states.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in depression and anxiety on PHQ-4 after intervention
The Patient Health Questionnaire-4 (PHQ-4) is a validated 4-item scale measuring depression and anxiety over the past two weeks. Rated on a 4-point scale from "not at all" to "nearly every day." Change = (Immediate after intervention - baseline) and (3 months after intervention - baseline)
Change from baseline in quality of life on EQ-5D-5L after intervention
EQ-5D-5L is a validated 6-item scale measuring quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) plus a visual analogue scale (EQ-VAS, 0-100). Higher scores indicate better quality of life. Change = (Immediate after intervention - baseline) and (3 months after intervention - baseline)
Change from baseline in loneliness on UCLA Loneliness Scale after intervention
The 3-item UCLA Loneliness Scale is a validated tool measuring feelings of loneliness and social isolation. The total score can range from 3 to 9. Higher scores indicate greater degrees of loneliness. Change = (Immediate after intervention - baseline) and (3 months after intervention - baseline)
Change from baseline in subjective happiness on Subjective Happiness Scale after intervention
The Subjective Happiness Scale is a validated 4-item scale measuring global subjective happiness on a 7-point Likert scale. Reverse the score for Item 4. Calculate the mean of all four item scores (the three regular scores plus the reversed score from Item 4). The total score ranges from 1 to 7. Higher scores indicate greater subjective happiness. Change = (Immediate after intervention - baseline) and (3 months after intervention - baseline)
Secondary outcomes
Change from baseline in cognitive function on MMSE after intervention (For CRs only)
The Mini-Mental State Examination (MMSE) is a validated 30-point questionnaire assessing cognitive function (orientation, memory, attention, etc.). Scores range from 0-30; higher scores indicate better function. Change = (Immediate after intervention - baseline) and (3 months after intervention - baseline)
Change from baseline in role captivity on Pearlin's model after intervention(For CGs only)
Pearlin's Role Captivity Scale is a 3-item tool measuring internal strain of caregiving role on a 4-point Likert scale. The total scores range from 3 to 12. Higher scores indicate greater role captivity. Change = (Immediate after intervention - baseline) and (3 months after intervention - baseline)
Change from baseline in technology acceptance on STAM after intervention
The Senior Technology Acceptance Model (STAM) is a validated 14-item scale consisted of a 4-factor structure (Attitudinal beliefs, Control beliefs, Gerontechnology anxiety, and Health). Each construct is measured by several items on a 10-point scale. For each of the four factors, calculate a composite score. This is done by taking the mean of all the items that load onto that factor. Additionally, a higher global score indicates a more positive overall attitude towards technology acceptance. Change = Immediate after intervention - baseline
4. Change from baseline in quality of life on OPQOL-brief after intervention (For CRs only)
The Older People's Quality of Life - brief questionnaire (OPQOL-brief) is a validated 13-item scale measuring QoL domains (health, social relationships, independence) on a 5-point Likert scale. Add together the scores from all 13 items after the reverse-scoring has been completed. The total score ranges from 13 to 65. A higher total score indicates a better self-reported quality of life. Change = (Immediate after intervention - baseline) and (3 months after intervention - baseline)
Sponsors and contacts
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