NCT06981117

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,166

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Apr 2024Oct 2027

Study Start

First participant enrolled

April 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

3.3 years

First QC Date

May 8, 2025

Last Update Submit

May 18, 2025

Conditions

Keywords

caregivercaregiving burdencaregiver wellbeing

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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

    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

    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.

    Baseline, immediate after service, 3, 6 and 12 months after the intervention

Other Outcomes (1)

  • Respite service details in each session, including the duration and content

    After each respite session

Study Arms (3)

Caregivers - Mild Needs

EXPERIMENTAL

Caregivers in Mild Needs level will receive 12 hours of respite service within 3 months

Other: 12 hr Respite Service

Caregivers - Moderate Needs

EXPERIMENTAL

Caregivers in Moderate Needs level will receive 36 hours of respite service within 3 months

Other: 36 hr Respite Service

Control Group

NO INTERVENTION

Control Group will receive no service.

Interventions

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.

Caregivers - Mild Needs

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.

Caregivers - Moderate Needs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

You may not qualify if:

  • Care recipient is receiving long-term care service

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sau Po Centre on Ageing

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Vivian Weiqun Lou

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivian Weiqun WQ Lou

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 20, 2025

Study Start

April 1, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Study protocol will be published and avaliable for public. Informed consent form and anonymous data will be uploaded to HKU Data Repository under embargo protection.
Access Criteria
Study protocol will be open to public. Informed consent form and anonymous data will be uploaded to HKU Data Repository under embargo protection, and will be provided under request.

Locations