Tech-based Respite Care for Caregivers and Homebound Older Adults

Официальное название

Tech-based Respite Care for Caregivers and Homebound Older Adults: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

All participants will be contacted for follow-up assessment 3 months after the completion of intervention.

Вмешательства

• Устройство VR-based Respite
  Caregivers 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.
• Устройство Video-based Respite
  Caregivers 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.

Первичные конечные точки

• Change from baseline in depression and anxiety on PHQ-4 after intervention [Срок оценки: Baseline, Immediate after intervention, and 3 months after intervention]
• Change from baseline in quality of life on EQ-5D-5L after intervention [Срок оценки: Baseline, Immediate after intervention, and 3 months after intervention]
• Change from baseline in loneliness on UCLA Loneliness Scale after intervention [Срок оценки: Baseline, Immediate after intervention, and 3 months after intervention]
• Change from baseline in subjective happiness on Subjective Happiness Scale after intervention [Срок оценки: Baseline, Immediate after intervention, and 3 months after intervention]

Вторичные конечные точки (5)

• Change from baseline in cognitive function on MMSE after intervention (For CRs only) [Срок оценки: : Baseline, Immediate after intervention, and 3 months after intervention]
• Change from baseline in role captivity on Pearlin's model after intervention(For CGs only) [Срок оценки: Baseline, Immediate after intervention, and 3 months after intervention]
• Change from baseline in technology acceptance on STAM after intervention [Срок оценки: Baseline and Immediate after intervention]
• 4. Change from baseline in quality of life on OPQOL-brief after intervention (For CRs only) [Срок оценки: Baseline, Immediate after intervention, and 3 months after intervention]
• Change from baseline in caregiving burden on CZBI-short after intervention (For CGs only) [Срок оценки: Baseline, Immediate after intervention, and 3 months after intervention]

Критерии участия

Caregivers (CGs)

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Гонконг · 1 центр

• Sau Po Centre on Ageing, HKU — Гонконг

Идентификаторы

NCT: NCT07160673 · 2024-0048-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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