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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

2026年7月28日 更新者:The Hong Kong Polytechnic University

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.

研究概览

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
安慰剂比较: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Robot-use adherence rate
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Adapted 6-item Capability, Opportunity, Motivation-Behaviour (COM-B) Self-Evaluation Questionnaire
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2028年6月30日

研究注册日期

首次提交

2026年7月23日

首先提交符合 QC 标准的

2026年7月28日

首次发布 (实际的)

2026年7月31日

研究记录更新

最后更新发布 (实际的)

2026年7月31日

上次提交的符合 QC 标准的更新

2026年7月28日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • S001856

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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