Caregiver BurdenVRDCFIn-home1NCT07004842
Alternative Carer Respite: A Study on Its Effectiveness and Potential Mechanism
A study testing 48 hr Respite Service in people with Caregiver Burden, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The primary objective of this study is to examine the effectiveness of alternative carer respite in meeting the unique needs of older adults without children or with limited contact with their children in Hong Kong. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- 48 hr Respite Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either the CR or CG is aged ≥60
- Reported having (a) no children; OR (b) no children in Hong Kong; OR (c) having children in Hong Kong but with limited contact (i.e., fewer than once per month in any forms)
- Voluntary participation.
Who cannot join
- Unable to communicate in neither Cantonese, English nor Mandarin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alternative Carer Respite: A Study on Its Effectiveness and Potential Mechanisms
The primary objective of this study is to examine the effectiveness of alternative carer respite in meeting the unique needs of older adults without children or with limited contact with their children in Hong Kong. Caregivers are assessed before and after the intervention, and three months after the end of intervention on their physical health, mental well-being, social engagement, and overall satisfaction.
Read the detailed description
All participants will provide informed consent at the time of enrolment. Both caregivers and their care recipients will complete an assessment. Caregivers are screened for their physical health, mental well-being, social engagement, and overall satisfaction. Care recipients are screened using InterRAI for their physical functions.
Caregivers will receive a maximal of 48 hours of respite service within 6 month. Alternative caregivers will provide in-home elderly-sitting service so that the caregivers can have some private time for themselves.
At the end of the service period, 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 months after the completion of service.
- Conditions
- Caregiver Burden
- Being tested
- 48 hr Respite Service
- Keywords
- respite, caregiver burden
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
48 hr Respite ServiceOther
Caregivers will be provided with 48 hours of respite service within 6 months. Trained alternative caregivers will provide elderly-sitting service at their home, allowing the caregivers to have their personal time.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Experimental | Caregivers will receive 48 hours of respite service within 6 months Receives: Other: 48 hr Respite 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 on the Carer Needs Screening Tool (CNST-11) after the intervention
The Carer Needs Screening Tool (CNST-11) is a self-developed tool that measures different aspects of caregiving needs over the past 1 week period. It is a 11-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 depression symptoms on PHQ-9 after the intervention
The Patient History Questionnaire (PHQ-9) is a widely used tool that consists of nine questions designed to screen and monitor the presence and severity of depression. The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. The score ranges for the PHQ-9 are as follows: 0-4: Minimal depression symptoms; 5-9: Mild depression; 10-14: Moderate depression; 15-19: Moderately severe depression; 20-27: Severe depression Change in score = Immediate after intervention - baseline
Measured: Baseline and Immediate after intervention
Change from baseline in score in anxiety symptoms on GAD-7 after the intervention
The Generalized Anxiety Disorder 7 (GAD-7) involves 7- items assessing the severity of anxiety symptoms. The total score on the GAD-7 ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. The score ranges for the GAD-7 are as follows: 0-4: Minimal anxiety symptoms; 5-9: Mild anxiety; 10-14: Moderate anxiety; 15-21: Severe anxiety.
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
Changes in score from baseline in perception of caregiving measured by Positive Aspect of Caregiving scale after intervention
The Positive Aspect of Caregiving scale is a 11-item scale that measures how the caregiver perceive caregiving experience, specifically in a positive aspect (e.g., caregiving makes me feel useful). It is rated in a 5-point Likert scale from "very disagree" to "very agree", with potential score from 0 to 44. A higher score indicates caregiving perceiving it in a more positive way.
Measured: Baseline and Immediate after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Dec 2023
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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, PhD, Principal investigator, Sau Po Centre on Ageing, University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004842
- Sponsor's protocol ID
- EA230565
- Acronym
- VRDCFIn-home1
- Status last verified
- Apr 2026
- First submitted
- 26 May 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD (including protocol and anonymized dataset) will be made available upon request, subject to ethical review and data protection regulations
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Carer Respite: A Study on Its Effectiveness and Potential Mechanisms
- ClinicalTrials.gov ID
- NCT07004842
- Acronym / sponsor ID
- VRDCFIn-home1 / EA230565
- Conditions
- Caregiver Burden
- Keywords
- respite, caregiver burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 4 Jun 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 primary objective of this study is to examine the effectiveness of alternative carer respite in meeting the unique needs of older adults without children or with limited contact with their children in Hong Kong. Caregivers are assessed before and after the intervention, and three months after the end of intervention on their physical health, mental well-being, social engagement, and overall satisfaction.
Detailed description
All participants will provide informed consent at the time of enrolment. Both caregivers and their care recipients will complete an assessment. Caregivers are screened for their physical health, mental well-being, social engagement, and overall satisfaction. Care recipients are screened using InterRAI for their physical functions.
Caregivers will receive a maximal of 48 hours of respite service within 6 month. Alternative caregivers will provide in-home elderly-sitting service so that the caregivers can have some private time for themselves.
At the end of the service period, 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 months after the completion of service.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers | Experimental | Other: 48 hr Respite ServiceCaregivers will receive 48 hours of respite service within 6 months |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Either the CR or CG is aged ≥60
- Reported having (a) no children; OR (b) no children in Hong Kong; OR (c) having children in Hong Kong but with limited contact (i.e., fewer than once per month in any forms)
- Voluntary participation.
Key exclusion criteria (1 listed)
- Unable to communicate in neither Cantonese, English nor Mandarin
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 |
|---|---|---|
| 48 hr Respite ServiceCaregivers will be provided with 48 hours of respite service within 6 months. Trained alternative caregivers will provide elderly-sitting service at their home, allowing the caregivers to have their personal time. | Other | Caregivers |
Primary outcome
Change from baseline in score in caregiving needs on the Carer Needs Screening Tool (CNST-11) after the intervention
Time frame: Baseline and Immediate after intervention
The Carer Needs Screening Tool (CNST-11) is a self-developed tool that measures different aspects of caregiving needs over the past 1 week period. It is a 11-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 depression symptoms on PHQ-9 after the intervention
Time frame: Baseline and Immediate after intervention
The Patient History Questionnaire (PHQ-9) is a widely used tool that consists of nine questions designed to screen and monitor the presence and severity of depression. The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. The score ranges for the PHQ-9 are as follows: 0-4: Minimal depression symptoms; 5-9: Mild depression; 10-14: Moderate depression; 15-19: Moderately severe depression; 20-27: Severe depression Change in score = Immediate after intervention - baseline
Change from baseline in score in anxiety symptoms on GAD-7 after the intervention
Time frame: Baseline and Immediate after intervention
The Generalized Anxiety Disorder 7 (GAD-7) involves 7- items assessing the severity of anxiety symptoms. The total score on the GAD-7 ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. The score ranges for the GAD-7 are as follows: 0-4: Minimal anxiety symptoms; 5-9: Mild anxiety; 10-14: Moderate anxiety; 15-21: Severe anxiety. 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
Changes in score from baseline in perception of caregiving measured by Positive Aspect of Caregiving scale after intervention
Time frame: Baseline and Immediate after intervention
The Positive Aspect of Caregiving scale is a 11-item scale that measures how the caregiver perceive caregiving experience, specifically in a positive aspect (e.g., caregiving makes me feel useful). It is rated in a 5-point Likert scale from "very disagree" to "very agree", with potential score from 0 to 44. A higher score indicates caregiving perceiving it in a more positive way.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided. IPD (including protocol and anonymized dataset) will be made available upon request, subject to ethical review and data protection regulations
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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. This study is not recruiting at the moment.
Vivian Weiqun Lou, PhD principal investigator
Sau Po Centre on Ageing, 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 48 hr Respite Service in people with Caregiver Burden, 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 3 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: finished, as of the sponsor's last update on 6 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in score in caregiving needs on the Carer Needs Screening Tool (CNST-11) 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?
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 6 May 2026.