Development of a Frailty Risk Prediction Model and Preliminary Evaluation of a Risk-stratified Social Robot-assisted Intervention in Middle-aged and Older Spousal Caregivers

Sponsor
The Hong Kong Polytechnic University
Study ID
NCT07740031
Status
Not Yet Recruiting

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Conditions

  • Frailty

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Virtual social robot-assisted intervention — BEHAVIORAL
    A virtual social robot-assisted intervention will be provided to participants. Participants will be encouraged to engage with the virtual social robot 3 times per week, with each structured session lasting approximately 20 minutes, over a 6-week intervention period.
  • Wait-list control group — BEHAVIORAL
    Participants allocated to the wait-list control group will receive delayed access to the virtual social robot intervention after completion of the final follow-up assessment.

Study Details

Background With population ageing accelerating worldwide, long-term care needs are rising, and family caregivers have become an essential yet often under-recognised component of care systems. Older family caregivers are particularly susceptible to frailty because they shoulder substantial caregiving responsibilities while simultaneously experiencing their own age-related decline in health and physiological reserve. Frailty is a clinically important state of heightened vulnerability to stressors and is associated with serious adverse outcomes, including disability, hospitalisation, and mortality. In family caregivers, frailty may compromise not only health and quality of life, but also their capacity to sustain caregiving, with wider implications for the sustainability of family-based long-term care. Research gaps A scoping review conducted by this team indicated that middle-aged and older family caregivers, particularly spousal caregivers, are vulnerable to frailty, with caregiving-related, sociodemographic, physical, psychological, and social factors contributing to this condition. However, existing evidence remains fragmented. Caregiver-specific prognostic tools for estimating future frailty risk are lacking, and risk-stratified interventions among family caregivers are sparse. Aim This study aims to develop and validate an incident frailty risk prediction model for middle-aged and older spousal caregivers, identify modifiable risk factors, as well as develop and preliminarily evaluate a risk-stratified, social robot-assisted intervention to reduce the risk of frailty. Methods This study comprises four phases. Phase 1 is a completed scoping review that mapped evidence on frailty among middle-aged and older family caregivers. Phase 2 will use longitudinal data from the China Health and Retirement Longitudinal Study (CHARLS) to develop and validate an incident frailty risk prediction model for middle-aged and older spousal caregivers and to construct an online risk calculator. Phase 3 will develop social robot-assisted intervention based on the Capability, Opportunity, Motivation-Behavior (COM-B) model. Phase 4 will assess the feasibility, acceptability, and examine preliminary effects of the intervention. Expected outcomes This study is expected to provide a caregiver-specific tool for early frailty risk identification and risk stratification among middle-aged and older spousal caregivers. It will also generate a theoretically guided, risk-stratified social robot-assisted intervention targeting modifiable risk factors for frailty and provide evidence on its feasibility and acceptability, as well as preliminary effects. The findings will inform a future definitive large-scale trial and community-based caregiver support services.

Key Dates

First listed
Jul 31, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jan 1, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: social robot-assisted intervention
    A social robot-assisted intervention wii be provided to participants. Participants will be encouraged to engage with the virtual social robot 3 times per week, with each structured session lasting approximately 20 minutes, over a 6-week intervention period.
  • Placebo Comparator: Wait-list control group
    Participants allocated to the wait-list control group will receive delayed access to the virtual social robot intervention after completion of the final follow-up assessment.

Primary Outcome Measure

Robot-use adherence rate [ Time Frame: Throughout the 6-week intervention period ]

Central Contacts

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