NCT07004842

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2023

Completed
1.5 years until next milestone

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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

May 26, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

respitecaregiver burden

Outcome Measures

Primary Outcomes (5)

  • 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 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

    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

    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

Other Outcomes (1)

  • Retention of changes of Primary outcome 1 to 5 after the end of intervention

    Baseline, immediate after intervention, 3 months after the intervention

Study Arms (1)

Caregivers

EXPERIMENTAL

Caregivers will receive 48 hours of respite service within 6 months

Other: 48 hr Respite Service

Interventions

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.

Caregivers

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to communicate in neither Cantonese, English nor Mandarin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Vivian Weiqun Lou, PhD

    Sau Po Centre on Ageing, University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
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

December 1, 2023

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations