Caregiver WellbeingVRDCFIn-home2NCT07004855
Tai Po Hidden Carers Support and Home-Based Respite Project
A study testing 30 hr Respite Service, Case follow-up and Crisis management in people with Caregiver Wellbeing, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The primary objective of this study is to identify and support hidden caregivers of older adults. Caregivers are assessed before the intervention on their mental well-being and social connectedness. Caregivers are triaged into four levels: low, mild, moderate and high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Wellbeing
- What is being tested?
- 30 hr Respite Service, Case follow-up and Crisis management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Jul 2025to 30 Jun 2028
- 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
- Provide ADL/IADL assistance to at least one older adult (aged 60+),
- Not currently using any types of respite service,
- Able to communicate in either Cantonese, English or Mandarin
- Voluntarily participate
Who cannot join
- The care recipient is not living in the community
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Not yet recruiting
University of Hong Kong
Hong Kong
Vivian Weiqun Lou, PhD, 85239174835, wlou@hku.hk
- Recruiting
University of Hong Kong
Hong Kong
Vivian Weiqun Lou, 852-28315210, tpcarer@hku.hk
About this study
The primary objective of this study is to identify and support hidden caregivers of older adults. Caregivers are assessed before the intervention on their mental well-being and social connectedness. Caregivers are triaged into four levels: low, mild, moderate and high. They will receive different types of services (intervention) accordingly. At the end of the service period (or 6-months after the baseline), caregivers and care recipients will complete the assessment again to measure the changes of the primary outcomes.
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 social connectedness. Care recipients are screened for their physical health and capacity in activities of daily living and instrumental activities of daily living.
Caregivers are triaged into four levels: low, mild, moderate and high. Caregivers in low level will receive case follow-up service, those in mild level will receive regular phone check-in, those in moderate level will receive a maximal of 30 hours of respite service within 6 month, and those in high level will receive professional counselling. At the end of the service period (or 6-months after the baseline), caregivers and care recipients will complete the assessment again to measure the changes of the primary outcomes.
- Conditions
- Caregiver Wellbeing
- Being tested
- 30 hr Respite Service, Case follow-up, Crisis management, Phone Check-in
- Keywords
- caregiver, respite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 hr Respite ServiceOther
Caregivers will be provided with 30 hours of respite service within 6 months. Trained substitute caregivers will provide in-home elderly-sitting service.
Case follow-upOther
Case follow-up service provided by social workers. Social workers will call the caregiver regularly to see if situation changes.
Crisis managementOther
Crisis management and councelling provided by social workers and professionals.
Phone Check-inOther
Regular phone check-in and on-demand services (e.g., escort to hospital) provided by volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver - Low level | Experimental | Caregivers in low level will receive case follow-up service from social workers Receives: Other: Case follow-up |
| Caregiver - Mild level | Experimental | Caregivers in mild level will receive regular phone check-in and on-demand services provided by volunteers Receives: Other: Phone Check-in |
| Caregivers - Moderate level | Experimental | Caregivers in moderate level will receive 30 hours of respite service within 6 months Receives: Other: 30 hr Respite Service |
| Caregiver - High level | Experimental | Caregivers in high level will receive crisis management and counselling from social workers and professionals. Receives: Other: Crisis management |
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 social support on MOS Social Support Survey after the intervention
The MOS Social Support Survey (MOSSSS) is a widely used tool that consists of 6 questions designed to measure the amount of support one needs. The total score ranges from 6 to 30, with higher scores indicating more support received.
Change in score = Immediate after intervention - baseline
Measured: Baseline and Immediate after intervention
Change from baseline in score in the severity and disturbance of symptoms of care recipient on Neuropsychiatric Inventory after the intervention
The Neuropsychiatric Inventory measures the severity and disturbance to caregiver of 13 common symtoms (e.g., dellusion, sleeping problem) of the care recipient. Severity is rated from 0 to 3, with 0 indicates no symptom and 3 indicates severe problem. Disturbance to caregiver is rated from 0 to 5, with 0 being not affected at all and 5 being extremely affected. The higher score in both subscales indicate worse problem.
Change in score = Immediate after intervention - baseline
Measured: Baseline and Immediate after intervention
Change from baseline in score in social connectedness on Social Connectedness Scale after the intervention
The Social Connectedness Scale consists of 6 items that measures how closely one feel that they are connected to the community. The total score on the scale can range from 8 to 48, with higher scores indicating a higher level of connectedness.
Change in score = Immediate after intervention - baseline
Measured: Baseline and Immediate after intervention
Change from baseline in score in the view on gender role on Gender Role Attitude Scale after the intervention
The Gender Role Attitude Scale consists of 3 items that measure the view on traditional gender role. The total score range from 3 to 15, with lower score indicate more traditional value.
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 Jul 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver WellbeingStudies 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
- 380 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004855
- Sponsor's protocol ID
- EA250321
- Acronym
- VRDCFIn-home2
- 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
- Yes: Informed consent form and anonymous data will be uploaded to HKU Data Repository under embargo protection.
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
- Tai Po Hidden Carers Support and Home-Based Respite Project
- ClinicalTrials.gov ID
- NCT07004855
- Acronym / sponsor ID
- VRDCFIn-home2 / EA250321
- Conditions
- Caregiver Wellbeing
- Keywords
- caregiver, respite
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- 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 identify and support hidden caregivers of older adults. Caregivers are assessed before the intervention on their mental well-being and social connectedness. Caregivers are triaged into four levels: low, mild, moderate and high. They will receive different types of services (intervention) accordingly. At the end of the service period (or 6-months after the baseline), caregivers and care recipients will complete the assessment again to measure the changes of the primary outcomes.
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 social connectedness. Care recipients are screened for their physical health and capacity in activities of daily living and instrumental activities of daily living.
Caregivers are triaged into four levels: low, mild, moderate and high. Caregivers in low level will receive case follow-up service, those in mild level will receive regular phone check-in, those in moderate level will receive a maximal of 30 hours of respite service within 6 month, and those in high level will receive professional counselling. At the end of the service period (or 6-months after the baseline), caregivers and care recipients will complete the assessment again to measure the changes of the primary outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caregiver - Low level | Experimental | Other: Case follow-upCaregivers in low level will receive case follow-up service from social workers |
| Caregiver - Mild level | Experimental | Other: Phone Check-inCaregivers in mild level will receive regular phone check-in and on-demand services provided by volunteers |
| Caregivers - Moderate level | Experimental | Other: 30 hr Respite ServiceCaregivers in moderate level will receive 30 hours of respite service within 6 months |
| Caregiver - High level | Experimental | Other: Crisis managementCaregivers in high level will receive crisis management and counselling from social workers and professionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide ADL/IADL assistance to at least one older adult (aged 60+),
- Not currently using any types of respite service,
- Able to communicate in either Cantonese, English or Mandarin
- Voluntarily participate
Key exclusion criteria (1 listed)
- The care recipient is not living in the community
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 |
|---|---|---|
| 30 hr Respite ServiceCaregivers will be provided with 30 hours of respite service within 6 months. Trained substitute caregivers will provide in-home elderly-sitting service. | Other | Caregivers - Moderate level |
| Case follow-upCase follow-up service provided by social workers. Social workers will call the caregiver regularly to see if situation changes. | Other | Caregiver - Low level |
| Crisis managementCrisis management and councelling provided by social workers and professionals. | Other | Caregiver - High level |
| Phone Check-inRegular phone check-in and on-demand services (e.g., escort to hospital) provided by volunteers. | Other | Caregiver - Mild level |
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 social support on MOS Social Support Survey after the intervention
Time frame: Baseline and Immediate after intervention
The MOS Social Support Survey (MOSSSS) is a widely used tool that consists of 6 questions designed to measure the amount of support one needs. The total score ranges from 6 to 30, with higher scores indicating more support received. Change in score = Immediate after intervention - baseline
Change from baseline in score in the severity and disturbance of symptoms of care recipient on Neuropsychiatric Inventory after the intervention
Time frame: Baseline and Immediate after intervention
The Neuropsychiatric Inventory measures the severity and disturbance to caregiver of 13 common symtoms (e.g., dellusion, sleeping problem) of the care recipient. Severity is rated from 0 to 3, with 0 indicates no symptom and 3 indicates severe problem. Disturbance to caregiver is rated from 0 to 5, with 0 being not affected at all and 5 being extremely affected. The higher score in both subscales indicate worse problem. Change in score = Immediate after intervention - baseline
Change from baseline in score in social connectedness on Social Connectedness Scale after the intervention
Time frame: Baseline and Immediate after intervention
The Social Connectedness Scale consists of 6 items that measures how closely one feel that they are connected to the community. The total score on the scale can range from 8 to 48, with higher scores indicating a higher level of connectedness. Change in score = Immediate after intervention - baseline
Change from baseline in score in the view on gender role on Gender Role Attitude Scale after the intervention
Time frame: Baseline and Immediate after intervention
The Gender Role Attitude Scale consists of 3 items that measure the view on traditional gender role. The total score range from 3 to 15, with lower score indicate more traditional value. 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
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 6 May 2026.
- Individual participant dataSharing planned: Yes. Informed consent form and anonymous data will be uploaded to HKU Data Repository under embargo protection.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 hr Respite Service, Case follow-up and Crisis management in people with Caregiver Wellbeing, run by The University of Hong Kong at 2 sites 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 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 2 sites 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 Lou (85239174835, 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 on the Carer Needs Screening Tool (CNST-11) after the intervention (time frame: Baseline and Immediate after intervention). The study lists 7 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.