{"type":"trials","record":{"id":30086,"source_id":"clinicaltrials-gov","external_id":"NCT07740031","title":"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","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.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"The Hong Kong Polytechnic University","enrollment":60,"countries":[],"start_date":"2026-08-01","completion_date":"2028-06-30","last_update_date":"2026-07-31","source_url":"https://clinicaltrials.gov/study/NCT07740031","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:16.485702+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"50 Years","comparator":"Wait-list control group","organization":"The Hong Kong Polytechnic University","interventions":["Virtual social robot-assisted intervention","Wait-list control group"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Robot-use adherence rate — Throughout the 6-week intervention period","Robot-use frequency — Throughout the 6-week intervention period","Participant retention rate — Week 6","The follow-up assessment completion rate — Week 6","Acceptability of the robot-based intervention assessed by semi-structured interviews — Week 6, following completion of…","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"],"design_description":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · DOUBLE","source_has_results":false},"controlled_terms":["Frailty","Virtual social robot-assisted intervention","Wait-list control group"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07740031","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-08-01 to 2028-06-30","comparator":"Wait-list control group","confidence":"structured-source","population":"ALL · 50 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.401Z","intervention":["Virtual social robot-assisted intervention","Wait-list control group"],"participants":60,"study_design":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Robot-use adherence rate — Throughout the 6-week intervention period","Robot-use frequency — Throughout the 6-week intervention period","Participant retention rate — Week 6","The follow-up assessment completion rate — Week 6","Acceptability of the robot-based intervention assessed by semi-structured interviews — Week 6, following completion of…","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"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/30086","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}