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Completed

NCT Number: NCT07004842

Alternative Carer Respite: A Study on Its Effectiveness and Potential Mechanism

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Unable to communicate in neither Cantonese, English nor Mandarin

Treatment and study plan

48 hr Respite Service

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

Other outcomes

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

    Time frame: Baseline, immediate after intervention, 3 months after the intervention

    Caregivers will complete the primary outcome measurements (1 to 5) 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 5 will be measured. Participants with improved/sustained score indicates better retention.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Alternative Carer Respite: A Study on Its Effectiveness and Potential Mechanisms

Acronym: VRDCFIn-home1

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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