NCT07004855

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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 Progress28%
Jul 2025Jun 2028

First Submitted

Initial submission to the registry

May 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

May 26, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

caregiverrespite

Outcome Measures

Primary Outcomes (7)

  • 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

    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

    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

    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

    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

    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

  • 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.

    Baseline and Immediate after intervention

Study Arms (4)

Caregiver - Low level

EXPERIMENTAL

Caregivers in low level will receive case follow-up service from social workers

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

Other: Phone Check-in

Caregivers - Moderate level

EXPERIMENTAL

Caregivers in moderate level will receive 30 hours of respite service within 6 months

Other: 30 hr Respite Service

Caregiver - High level

EXPERIMENTAL

Caregivers in high level will receive crisis management and counselling from social workers and professionals.

Other: Crisis management

Interventions

Caregivers will be provided with 30 hours of respite service within 6 months. Trained substitute caregivers will provide in-home elderly-sitting service.

Caregivers - Moderate level

Case follow-up service provided by social workers. Social workers will call the caregiver regularly to see if situation changes.

Caregiver - Low level

Crisis management and councelling provided by social workers and professionals.

Caregiver - High level

Regular phone check-in and on-demand services (e.g., escort to hospital) provided by volunteers.

Caregiver - Mild level

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The care recipient is not living in the community

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Hong Kong

Hong Kong, Hong Kong

NOT YET RECRUITING

University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Crew Resource Management, Healthcare

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Central Study Contacts

Vivian Weiqun Lou

CONTACT

Linda Dongling Wang, PhD

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
Director, Professor

Study Record Dates

First Submitted

May 26, 2025

First Posted

June 4, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Informed consent form and anonymous data will be uploaded to HKU Data Repository under embargo protection.

Shared Documents
ICF
Time Frame
Beginning 3 months and ending 3 years after the publication of results
Access Criteria
Informed consent form and anonymous data will be uploaded to HKU Data Repository under embargo protection.

Locations