Caregiver BurnoutStandByU2NCT06981117
Jockey Club Stand-by-U Caregivers Community Support Project: In-home Respite for Caregivers of Older Adults
A study testing 12 hr Respite Service and 36 hr Respite Service in people with Caregiver Burnout and Caregiver Wellbeing, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this study is to investigate whether the in-home respite service model is effective in relieving caregiver's burden and improving their mental wellbeing. Caregivers are triaged into four levels of needs using a self-developed screening tool. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burnout, Caregiver Wellbeing
- What is being tested?
- 12 hr Respite Service and 36 hr Respite Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,166 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2024to 31 Oct 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
Who cannot join
- Care recipient is receiving long-term care service
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Jockey Club Stand-by-U Caregivers Community Support Project
The goal of this study is to investigate whether the in-home respite service model is effective in relieving caregiver's burden and improving their mental wellbeing. Caregivers are triaged into four levels of needs using a self-developed screening tool. Those screened as mild and moderate levels are admitted to the study, while those in low or high-needs levels are referred to other services.
Caregivers admitted in this study will receive either 12 or 36 hours of in-home respite services as the intervention. Trained volunteers or substitute caregivers will visit their home to take care the older adults, providing several hours of free time for the caregivers.
Read more
Assessments are conducted before and immediate after the intervention, and 3, 6, 12 months after the completion of intervention, to measure the changes in mental wellbeing of the caregivers.
A control group with no respite service provided is recruited to compare the effects in the changes of mental wellbeing.
Read the detailed description
All participants will provide informed consent at the time of enrolment. Both caregivers and their care recipients will complete assessment before the respite service period.
Care recipients are assessed for their self-dependent ability in daily activities and their physical health condition.
Caregivers are screened for their overall needs level using a self-developed multidimensional screening tool. Those screened as High Needs level will be referred professional services. Those screened as Low will be recommended to join centre-based services. Caregivers who are in Mild or Moderate needs levels will be admitted to this project. They are also assessed using standard tests for measuring changes in mental health (using Depression Anxiety Stress Scales - Short Form (DASS-21)), caregiving burden (using Chinese Version of the Zarit Caregiver Burden Interview) and quality of life (using EQ-5D-5L).
As the intervention, caregivers in Mild-needs level will receive 12 hours of in-home respite service, whereas those in Moderate-level will receive 36 hours of service. Volunteer or substitute caregivers will provide in-home elderly-sitting service so that the caregivers can have some private time for themselves.
At the end of the intervention, caregivers and care recipients will complete the assessment again to measure the changes of their physical and mental health.
All participants will be contacted again for follow-up assessment 3, 6 and 12 months after the completion of intervention.
A control group with no respite service provided is recruited to compare the effects in the changes of mental wellbeing. They are contacted 3, 6 and 12 months after baseline measurement.
- Conditions
- Caregiver Burnout, Caregiver Wellbeing
- Being tested
- 12 hr Respite Service, 36 hr Respite Service
- Keywords
- caregiver, caregiving burden, caregiver wellbeing
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 hr Respite ServiceOther
12 hours of respite service within 3 months will be provided by volunteers. Volunteers will provide elderly-sitting service (accompany the care recipient) during the service session, and provide cognitive training or physical training to the care recipient if situation allows.
36 hr Respite ServiceOther
36 hours of respite service within 3 months will be provided by substitute caregivers. Substitute caregivers will provide elderly-sitting service (accompany the care recipient) during the service session, and provide cognitive training or physical training to the care recipient if situation allows.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers - Mild Needs | Experimental | Caregivers in Mild Needs level will receive 12 hours of respite service within 3 months Receives: Other: 12 hr Respite Service |
| Caregivers - Moderate Needs | Experimental | Caregivers in Moderate Needs level will receive 36 hours of respite service within 3 months Receives: Other: 36 hr Respite Service |
| Control Group | No intervention | Control Group will receive no service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in score in caregiving needs measured by Multidimensional screening tool after the intervention
The Multidimensional screening tool is a self-developed tool that measures different aspects of caregiving needs over the past 1 week period. It is a 22-item scale, with 8 items that determines the overall needs level and the others for four aspects of needs: physical health, mental health, social support and care needs. Possible score is from 8 to 32 with lower score indicates lower caregivers' needs.
Change in score = Immediate after intervention - baseline
Measured: Baseline and Immediate after intervention
Change from baseline in score in mental wellbeing measured by DASS-21 scale after intervention
The DASS-21 comprises 21 items that assess symptoms of depression, anxiety, and stress over the past week. Each item is rated on a 4-point Likert scale, with higher scores indicating greater symptom severity. The total scores for each subscale (Depression, Anxiety, Stress) are calculated by summing the relevant item scores. Possible score for each subscale ranged from 0 to 42, with 0 indicates best outcome and 42 the worst outcome.
Reductions in DASS-21 scores indicate improvements in symptoms of depression, anxiety, and stress following the intervention.
Change in score = Immediate after intervention- baseline
Measured: Baseline and Immediate after intervention
Change in score from baseline in caregiving burden measured by CZBI after intervention
The Chinese version of Zarit Caregiver Burden Inventory (CZBI) is a widely used tool designed to assess caregiver burden and distress experienced by individuals caring for a loved one with a chronic illness or disability. It comprises of 12 items, and each item is rated on a 5-point Likert scale. Possible score ranged from 0 to 48, with higher scores indicating greater levels of caregiver burden.
Change in score= Immediate after intervention - baseline
Measured: Baseline and Immediate after intervention
Change in score from baseline in quality of life measured by EQ-5D-5L after intervention
The EQ-5D-5L is a standardized instrument used to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses are converted into a single index value representing overall health status using Hong Kong's normative value. The primary outcome measure in this study is the change in EQ-5D-5L index scores from baseline to post-intervention/follow-up assessments. 1 equals to perfect health and more negative numbers indicates worse health.
Change in health index = Immediate after intervention - baseline
Measured: Baseline and Immediate after intervention
Retention of changes of Primary outcome 1 to 4 after the end of intervention
Caregivers will complete the primary outcome measurements (1 to 4) again 3, 6 and 12 months after the end of the intervention. They will not receive any in-home respite service from the project in between the measurement periods.
Changes in score of each scale in Primary Outcome 1 to 4 will be measured. Participants with improved/sustained score indicates better retention.
Measured: Baseline, immediate after service, 3, 6 and 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Apr 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurnoutStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Vivian W.Q. Lou, The University of Hong Kong
- Investigators
- Vivian Weiqun Lou, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981117
- Sponsor's protocol ID
- 2024-0048-007
- Other IDs
- 2024-0048-007
- Acronym
- StandByU2
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hui NY, Wang LD, Yiu J, Feng MG, Lu P, Lou VWQ. JC Stand-by-U- development and evaluation of an in-home respite service model using mixed-method quasi-experimental design: study protocol. BMC Geriatr. 2025 Aug 27;25(1):665. doi: 10.1186/s12877-025-06294-w.
PubMed 40866876
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jockey Club Stand-by-U Caregivers Community Support Project
- ClinicalTrials.gov ID
- NCT06981117
- Acronym / sponsor ID
- StandByU2 / 2024-0048-007
- Conditions
- Caregiver Burnout, Caregiver Wellbeing
- Keywords
- caregiver, caregiving burden, caregiver wellbeing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,166 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 20 May 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 investigate whether the in-home respite service model is effective in relieving caregiver's burden and improving their mental wellbeing. Caregivers are triaged into four levels of needs using a self-developed screening tool. Those screened as mild and moderate levels are admitted to the study, while those in low or high-needs levels are referred to other services.
Caregivers admitted in this study will receive either 12 or 36 hours of in-home respite services as the intervention. Trained volunteers or substitute caregivers will visit their home to take care the older adults, providing several hours of free time for the caregivers.
Assessments are conducted before and immediate after the intervention, and 3, 6, 12 months after the completion of intervention, to measure the changes in mental wellbeing of the caregivers.
A control group with no respite service provided is recruited to compare the effects in the changes of mental wellbeing.
Detailed description
All participants will provide informed consent at the time of enrolment. Both caregivers and their care recipients will complete assessment before the respite service period.
Care recipients are assessed for their self-dependent ability in daily activities and their physical health condition.
Caregivers are screened for their overall needs level using a self-developed multidimensional screening tool. Those screened as High Needs level will be referred professional services. Those screened as Low will be recommended to join centre-based services. Caregivers who are in Mild or Moderate needs levels will be admitted to this project. They are also assessed using standard tests for measuring changes in mental health (using Depression Anxiety Stress Scales - Short Form (DASS-21)), caregiving burden (using Chinese Version of the Zarit Caregiver Burden Interview) and quality of life (using EQ-5D-5L).
As the intervention, caregivers in Mild-needs level will receive 12 hours of in-home respite service, whereas those in Moderate-level will receive 36 hours of service. Volunteer or substitute caregivers will provide in-home elderly-sitting service so that the caregivers can have some private time for themselves.
At the end of the intervention, caregivers and care recipients will complete the assessment again to measure the changes of their physical and mental health.
All participants will be contacted again for follow-up assessment 3, 6 and 12 months after the completion of intervention.
A control group with no respite service provided is recruited to compare the effects in the changes of mental wellbeing. They are contacted 3, 6 and 12 months after baseline measurement.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caregivers - Mild Needs | Experimental | Other: 12 hr Respite ServiceCaregivers in Mild Needs level will receive 12 hours of respite service within 3 months |
| Caregivers - Moderate Needs | Experimental | Other: 36 hr Respite ServiceCaregivers in Moderate Needs level will receive 36 hours of respite service within 3 months |
| Control Group | No intervention | –Control Group will receive no service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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
Key exclusion criteria (1 listed)
- Care recipient is receiving long-term care service
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 |
|---|---|---|
| 12 hr Respite Service12 hours of respite service within 3 months will be provided by volunteers. Volunteers will provide elderly-sitting service (accompany the care recipient) during the service session, and provide cognitive training or physical training to the care recipient if situation allows. | Other | Caregivers - Mild Needs |
| 36 hr Respite Service36 hours of respite service within 3 months will be provided by substitute caregivers. Substitute caregivers will provide elderly-sitting service (accompany the care recipient) during the service session, and provide cognitive training or physical training to the care recipient if situation allows. | Other | Caregivers - Moderate Needs |
Primary outcome
Change from baseline in score in caregiving needs measured by Multidimensional screening tool after the intervention
Time frame: Baseline and Immediate after intervention
The Multidimensional screening tool is a self-developed tool that measures different aspects of caregiving needs over the past 1 week period. It is a 22-item scale, with 8 items that determines the overall needs level and the others for four aspects of needs: physical health, mental health, social support and care needs. Possible score is from 8 to 32 with lower score indicates lower caregivers' needs. Change in score = Immediate after intervention - baseline
Change from baseline in score in mental wellbeing measured by DASS-21 scale after intervention
Time frame: Baseline and Immediate after intervention
The DASS-21 comprises 21 items that assess symptoms of depression, anxiety, and stress over the past week. Each item is rated on a 4-point Likert scale, with higher scores indicating greater symptom severity. The total scores for each subscale (Depression, Anxiety, Stress) are calculated by summing the relevant item scores. Possible score for each subscale ranged from 0 to 42, with 0 indicates best outcome and 42 the worst outcome. Reductions in DASS-21 scores indicate improvements in symptoms of depression, anxiety, and stress following the intervention. Change in score = Immediate after intervention- baseline
Change in score from baseline in caregiving burden measured by CZBI after intervention
Time frame: Baseline and Immediate after intervention
The Chinese version of Zarit Caregiver Burden Inventory (CZBI) is a widely used tool designed to assess caregiver burden and distress experienced by individuals caring for a loved one with a chronic illness or disability. It comprises of 12 items, and each item is rated on a 5-point Likert scale. Possible score ranged from 0 to 48, with higher scores indicating greater levels of caregiver burden. Change in score= Immediate after intervention - baseline
Change in score from baseline in quality of life measured by EQ-5D-5L after intervention
Time frame: Baseline and Immediate after intervention
The EQ-5D-5L is a standardized instrument used to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses are converted into a single index value representing overall health status using Hong Kong's normative value. The primary outcome measure in this study is the change in EQ-5D-5L index scores from baseline to post-intervention/follow-up assessments. 1 equals to perfect health and more negative numbers indicates worse health. Change in health index = Immediate after intervention - baseline
Retention of changes of Primary outcome 1 to 4 after the end of intervention
Time frame: Baseline, immediate after service, 3, 6 and 12 months after the intervention
Caregivers will complete the primary outcome measurements (1 to 4) again 3, 6 and 12 months after the end of the intervention. They will not receive any in-home respite service from the project in between the measurement periods. Changes in score of each scale in Primary Outcome 1 to 4 will be measured. Participants with improved/sustained score indicates better retention.
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 20 May 2025.
- Derived from this study: PubMed 40866876Hui NY, Wang LD, Yiu J, Feng MG, Lu P, Lou VWQ. JC Stand-by-U- development and evaluation of an in-home respite service model using mixed-method quasi-experimental design: study protocol. BMC Geriatr. 2025 Aug 27;25(1):665. doi: 10.1186/s12877-025-06294-w.
- Individual participant dataSharing planned: Yes
Related trials for Caregiver Burnout
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Recruiting
Caring for the Carer
Care Burden, Care Giving Burden
Not yet recruitingPhase 2
Peer Support for Family Caregivers of Older Adults Living With Dementia
Caregiver Burden, Caregiver Burnout
Enrolling by invitation
Evaluation of the CBSM Program Online and in Person to Reduce Caregiver Burnout
Burnout, Caregiver
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.
Vivian Weiqun Lou principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 hr Respite Service and 36 hr Respite Service in people with Caregiver Burnout and Caregiver Wellbeing, run by The University of Hong Kong 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 4 inclusion and 1 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 20 May 2025. 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 Vivian Weiqun WQ Lou (852-39174835, wlou@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 score in caregiving needs measured by Multidimensional screening tool after the intervention (time frame: Baseline and Immediate after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06981117, which also lists 1 linked publication.
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 20 May 2025.