NCT Number: NCT07740031
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.
Trial opening soon.
Get Notified50 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline and Week 6
Individual frailty risk probability will be estimated using the online frailty calculator developed by our team.
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.
Contact information is provided by the study sponsor or research team.
The Hong Kong Polytechnic University
Other
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