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

Overview

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.

Interventions

• Behavioral Virtual social robot-assisted intervention
  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.
• Behavioral 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 measures

• Robot-use adherence rate [Time frame: Throughout the 6-week intervention period]
• Robot-use frequency [Time frame: Throughout the 6-week intervention period]
• Participant retention rate [Time frame: Week 6]
• The follow-up assessment completion rate [Time frame: Week 6]
• Acceptability of the robot-based intervention assessed by semi-structured interviews [Time frame: Week 6, following completion of the intervention]

Secondary outcome measures (4)

• Adapted 6-item Capability, Opportunity, Motivation-Behaviour (COM-B) Self-Evaluation Questionnaire [Time frame: Baseline and Week 6]
• Fried's frailty phenotype [Time frame: Baseline and Week 6]
• Frailty Risk Probability [Time frame: Baseline and Week 6]
• Modifiable Frailty Risk-Factor Indicator [Time frame: Baseline and Week 6]

Eligibility criteria

Inclusion criteria

• aged 50 years or older
• currently being a spouse caregiver
• assessed as being at high risk level frailty by the developed online risk calculator
• being able to use the social robot through a smartphone or tablet, either independently or with necessary guidance
• willing to sign informed consent and participate in study

Exclusion criteria

• those with acute mental disorders or disabling diseases that may limit the practice of engaging with a robot
• acute disease attack or acute medical condition
• currently participating in another intervention or clinical trial
• who have limited access to electricity, which would make it hard for them to use technology at home

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07740031 · S001856

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗