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

NCT07740031 | Not Yet Recruiting

• 1 other identifier: S001856
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Frailty

Outcome Measures

Primary Outcomes (5)

• Robot-use adherence rate

  Robot-use adherence will be assessed using automatically recorded robot usage logs. Adherence will be calculated for each participant as the number of prescribed robot-use sessions completed divided by the total number of robot-use sessions prescribed during the 6-week intervention period, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence to the prescribed robot-use schedule.

  Throughout the 6-week intervention period

• Robot-use frequency

  Robot-use frequency will be assessed using automatically recorded robot usage logs. A robot-use session will be defined as one recorded episode of interaction with the robot. The number of robot-use sessions completed by each participant will be summarized as the mean number of sessions per week across the 6-week intervention period. A higher number indicates more frequent robot use.

  Throughout the 6-week intervention period

• Participant retention rate

  The participant retention rate will be calculated as the number of enrolled participants who remain in the study and have not withdrawn by Week 6 divided by the total number of participants enrolled, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater participant retention.

  Week 6

• The follow-up assessment completion rate

  The follow-up assessment completion rate will be calculated as the number of participants who complete the scheduled Week 6 follow-up assessment divided by the total number of enrolled participants expected to complete the assessment, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater follow-up completion.

  Week 6

• Acceptability of the robot-based intervention assessed by semi-structured interviews

  All participants in the intervention group will be invited to participate in an individual semi-structured interview at Week 6. Interviews will explore participants' experiences of using the robot at home and their perceptions of the acceptability of the intervention. Interview data will be analyzed using thematic analysis and reported as themes and subthemes related to participants' experiences and perceived acceptability. No numerical scale score will be calculated.

  Week 6, following completion of the intervention

Secondary Outcomes (4)

• Adapted 6-item Capability, Opportunity, Motivation-Behaviour (COM-B) Self-Evaluation Questionnaire

  Baseline and Week 6

• Fried's frailty phenotype

  Baseline and Week 6

• Frailty Risk Probability

  Baseline and Week 6

• Modifiable Frailty Risk-Factor Indicator

  Baseline and Week 6

Study Arms (2)

social robot-assisted intervention

EXPERIMENTAL

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.

Behavioral: Virtual social robot-assisted intervention

Wait-list control group

PLACEBO COMPARATOR

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.

Behavioral: Wait-list control group

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.

social robot-assisted intervention

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.

Wait-list control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ivy Yan Zhao

CONTACT

+8527664550; yan-ivy.zhao@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share