Caregiver StressTechRespiteRCTNCT07160673
Tech-based Respite Care for Caregivers and Homebound Older Adults
A study testing VR-based Respite and Video-based Respite in people with Caregiver Stress and Social Isolation in Older Adults, run by Hong Kong University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Stress, Social Isolation in Older Adults, Cognitive Decline in Older Adults
- What is being tested?
- VR-based Respite and Video-based Respite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2025to 28 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Sau Po Centre on Ageing, HKU
Hong Kong, 香港島
Linda Wang, 852-39102278, ldlw@hku.hk
Dongling Linda Wang, PhD
About this study
Official title: Tech-based Respite Care for Caregivers and Homebound Older Adults: A Randomized Controlled 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Caregiver Stress, Social Isolation in Older Adults, Cognitive Decline in Older Adults, Depression in Older Adults, Anxiety in Older Adults
- Being tested
- VR-based Respite, Video-based Respite
- Keywords
- Virtual Reality, Respite Care, Caregivers, Older Adults, Randomized Controlled Trial, Mental Health, Cognitive Function, uality of Life
- Medical subject headings
- Caregiver Burden, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based RespiteDevice
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.
Video-based RespiteDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VR Intervention Group | Experimental | Caregivers and homebound older adults will receive 4 weeks of VR-based respite sessions. Receives: Device: VR-based Respite |
| Video Control Group | Active comparator | Caregivers and homebound older adults will receive 4 weeks of video-based respite sessions. Receives: Device: Video-based Respite |
| Usual Care Group | No intervention | Caregivers and homebound older adults will receive no additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
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)
Measured: : Baseline, Immediate after intervention, and 3 months after intervention
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)
Measured: Baseline, Immediate after intervention, and 3 months after intervention
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
Measured: Baseline and Immediate after intervention
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)
Measured: Baseline, Immediate after intervention, and 3 months after intervention
Change from baseline in caregiving burden on CZBI-short after intervention (For CGs only)
The Cantonese short version of the Zarit Burden Interview (CZBI-short) is a validated 12-item scale measuring caregiver burden on a 5-point Likert scale (0=never to 4=very frequently). Scores range from 0-48; higher scores indicate greater burden.
Change = (Immediate after intervention - baseline) and (3 months after intervention - baseline)
Measured: Baseline, Immediate after intervention, and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion28 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Dong-Ling Wang, Hong Kong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160673
- Sponsor's protocol ID
- 2024-0048-007
- Acronym
- TechRespiteRCT
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tech-based Respite Care for Caregivers and Homebound Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07160673
- Acronym / sponsor ID
- TechRespiteRCT / 2024-0048-007
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hong Kong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 28 Aug 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR Intervention Group | Experimental | Device: VR-based RespiteCaregivers and homebound older adults will receive 4 weeks of VR-based respite sessions. |
| Video Control Group | Active comparator | Device: Video-based RespiteCaregivers and homebound older adults will receive 4 weeks of video-based respite sessions. |
| Usual Care Group | No intervention | –Caregivers and homebound older adults will receive no additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-based RespiteCaregivers 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. | Device | VR Intervention Group |
| Video-based RespiteCaregivers 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. | Device | Video Control Group |
Primary outcome
Change from baseline in depression and anxiety on PHQ-4 after intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
5 secondary outcomes
Change from baseline in cognitive function on MMSE after intervention (For CRs only)
Time frame: : Baseline, Immediate after intervention, and 3 months after intervention
Change from baseline in role captivity on Pearlin's model after intervention(For CGs only)
Time frame: Baseline, Immediate after intervention, and 3 months after intervention
Change from baseline in technology acceptance on STAM after intervention
Time frame: Baseline and Immediate after intervention
4. Change from baseline in quality of life on OPQOL-brief after intervention (For CRs only)
Time frame: Baseline, Immediate after intervention, and 3 months after intervention
Change from baseline in caregiving burden on CZBI-short after intervention (For CGs only)
Time frame: Baseline, Immediate after intervention, and 3 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based Respite and Video-based Respite in people with Caregiver Stress and Social Isolation in Older Adults, run by Hong Kong University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongling Linda Wang, PhD (852-39102278, ldlw@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in depression and anxiety on PHQ-4 after intervention (time frame: Baseline, Immediate after intervention, and 3 months after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.