Tech-based Respite Care for Caregivers and Homebound Older Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change from baseline in depression and anxiety on PHQ-4 after intervention
研究概览
简要总结
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.
详细描述
All participants will provide informed consent at the time of enrolment. Both caregivers (CGs) and care recipients (CRs) will complete assessments at baseline.
CRs are assessed for cognitive function (using Mini-Mental State Examination - MMSE) and other health indicators. CGs are assessed for mental health, quality of life, and caregiving burden.
Participants are randomized into three groups: VR intervention (n=30 dyads), video control (n=30 dyads), or usual care (n=30 dyads). Randomization is stratified by CG age (<60 vs. ≥60) and CR cognitive status (MMSE <24 vs. ≥24).
As the intervention, the VR group receives 4 weekly 30-minute sessions of immersive VR experiences (e.g., virtual travel and social activities) facilitated by trained research staff. The video group receives 4 weekly 30-minute sessions of non-immersive videos with similar themes, also facilitated. The usual care group receives no additional intervention beyond community services.
At the end of the intervention, participants complete assessments again to measure changes in physical and mental health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregivers (CGs)
- •Inclusion Criteria:
- •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
- •Willing to participate for the entire duration
- •Able to tolerate VR headset for at least 5 minutes (no severe motion sickness/epilepsy)
排除标准
- •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
- •Unable to tolerate VR due to motion sickness or discomfort
- •Care recipient receiving long-term care service that conflicts with study
- •Care Recipients (CRs)
- •Inclusion Criteria:
- •Aged 60 or above
- •Homebound (unable to leave home without assistance)
- •Stable medical condition
- •Willing to participate for the entire duration
- •Able to tolerate VR headset for at least 5 minutes (no VR contraindications)
- •Able to understand and provide informed consent Exclusion Criteria: Same as CGs, plus MMSE <10
研究组 & 干预措施
Usual Care Group
Caregivers and homebound older adults will receive no additional intervention.
VR Intervention Group
Caregivers and homebound older adults will receive 4 weeks of VR-based respite sessions.
干预措施: VR-based Respite (Device)
Video Control Group
Caregivers and homebound older adults will receive 4 weeks of video-based respite sessions.
干预措施: Video-based Respite (Device)
结局指标
主要结局
Change from baseline in depression and anxiety on PHQ-4 after intervention
时间窗: Baseline, Immediate after intervention, and 3 months 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 loneliness on UCLA Loneliness Scale after intervention
时间窗: Baseline, Immediate after intervention, and 3 months 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
时间窗: Baseline, Immediate after intervention, and 3 months 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)
Change from baseline in depression and anxiety on PHQ-4 after intervention
时间窗: Baseline, Immediate after intervention, and 3 months 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
时间窗: Baseline, Immediate after intervention, and 3 months 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
时间窗: Baseline, Immediate after intervention, and 3 months 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
时间窗: Baseline, Immediate after intervention, and 3 months 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)
次要结局
- Change from baseline in role captivity on Pearlin's model after intervention(For CGs only)(Baseline, Immediate after intervention, and 3 months after intervention)
- Change from baseline in technology acceptance on STAM after intervention(Baseline and Immediate after intervention)
- 4. Change from baseline in quality of life on OPQOL-brief after intervention (For CRs only)(Baseline, Immediate after intervention, and 3 months after intervention)
- Change from baseline in caregiving burden on CZBI-short after intervention (For CGs only)(Baseline, Immediate after intervention, and 3 months after intervention)
- Change from baseline in cognitive function on MMSE after intervention (For CRs only)(: Baseline, Immediate after intervention, and 3 months after intervention)
- Change from baseline in role captivity on Pearlin's model after intervention(For CGs only)(Baseline, Immediate after intervention, and 3 months after intervention)
- Change from baseline in technology acceptance on STAM after intervention(Baseline and Immediate after intervention)
- 4. Change from baseline in quality of life on OPQOL-brief after intervention (For CRs only)(Baseline, Immediate after intervention, and 3 months after intervention)
研究者
Linda Dong-Ling Wang
Research Assistant Professor
Hong Kong University