Tech-based Respite Care for Caregivers and Homebound Older Adults

NCT07160673 | Not Yet Recruiting

• 1 other identifier: 2024-0048-007
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caregiver Stress; Social Isolation in Older Adults; Cognitive Decline in Older Adults; Depression in Older Adults; Anxiety in Older Adults

Keywords

Virtual Reality; Respite Care; Caregivers; Older Adults; Randomized Controlled Trial; Mental Health; Cognitive Function; uality of Life

Outcome Measures

Primary Outcomes (4)

• 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)

  Baseline, Immediate after intervention, and 3 months after intervention

• 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)

  Baseline, Immediate after intervention, and 3 months after intervention

• 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)

  Baseline, Immediate after intervention, and 3 months after intervention

• 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)

  Baseline, Immediate after intervention, and 3 months after intervention

Secondary Outcomes (5)

• 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

• Change from baseline in caregiving burden on CZBI-short after intervention (For CGs only)

  Baseline, Immediate after intervention, and 3 months after intervention

Study Arms (3)

VR Intervention Group

EXPERIMENTAL

Caregivers and homebound older adults will receive 4 weeks of VR-based respite sessions.

Device: VR-based Respite

Video Control Group

ACTIVE COMPARATOR

Caregivers and homebound older adults will receive 4 weeks of video-based respite sessions.

Device: Video-based Respite

Usual Care Group

NO INTERVENTION

Caregivers and homebound older adults will receive no additional intervention.

Interventions

VR-based Respite DEVICE

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.

VR Intervention Group

Video-based Respite DEVICE

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.

Video Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Hong Kong University: lead

Study Sites (1)

Sau Po Centre on Ageing, HKU

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Caregiver Burden; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction

Central Study Contacts

Dongling Linda Wang, PhD

CONTACT

852-39102278; ldlw@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)