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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ivy Yan Zhao
- Phone Number: +8527664550
- Email: yan-ivy.zhao@polyu.edu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Robot-use adherence rate
Time Frame: Throughout the 6-week intervention period
|
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
Time Frame: Throughout the 6-week intervention period
|
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
Time Frame: Week 6
|
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
Time Frame: Week 6
|
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
Time Frame: Week 6, following completion of the intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adapted 6-item Capability, Opportunity, Motivation-Behaviour (COM-B) Self-Evaluation Questionnaire
Time Frame: Baseline and Week 6
|
Capability, opportunity, and motivation to engage in frailty risk-management behaviours will be assessed using the Adapted 6-item Capability, Opportunity, Motivation-Behaviour Self-Evaluation Questionnaire (Keyworth et al., 2020).
The questionnaire contains six items assessing physical capability, psychological capability, physical opportunity, social opportunity, reflective motivation, and automatic motivation.
Each item is rated from 0 to 10. Item scores will be summed to produce a total score ranging from 0 to 60. Higher scores indicate greater overall perceived capability, opportunity, and motivation to engage in frailty risk-management behaviours.
|
Baseline and Week 6
|
|
Fried's frailty phenotype
Time Frame: Baseline and Week 6
|
Frailty will be assessed using Fried's frailty phenotype, which includes five criteria: slowness, weakness, unintentional weight loss, low physical activity, and exhaustion.
One point will be assigned for each criterion present, resulting in a total score ranging from 0 to 5. Participants will be classified as non-frail if no criteria are present, pre-frail if one or two criteria are present, and frail if three or more criteria are present.
Higher scores indicate a greater level of frailty.
|
Baseline and Week 6
|
|
Frailty Risk Probability
Time Frame: Baseline and Week 6
|
Individual frailty risk probability will be estimated using the online frailty calculator developed by our team.
|
Baseline and Week 6
|
|
Modifiable Frailty Risk-Factor Indicator
Time Frame: Baseline and Week 6
|
Based on the modifiable risk factors identified in phase 3, indicators may include physical activity, sleep quality, nutritional status, depression, social support, and caregiver intensity.
Appropriate validated scales will be used for modifiable risk factor.
|
Baseline and Week 6
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S001856
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.