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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07740031 · S001856

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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