[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629821":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":30,"collaborators":26,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":26,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":26,"enrollmentInfo":43,"targetDuration":26,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":26,"overallStatus":56,"whyStopped":26,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":26},{"fullName":5,"class":6},"Mackay Memorial Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-Based Voice Emotion Detection-Guided Counselling (Intervention)","EXPERIMENTAL","Participants assigned to this arm will receive an artificial intelligence-based voice emotion detection-guided counselling intervention in addition to usual care. The intervention uses voice emotion analysis to provide personalized psychological feedback and counselling aimed at improving emotional regulation, reducing psychological distress, and enhancing quality of life.",[13],"Behavioral: AI-Based Voice Emotion Detection-Guided Counselling",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care (Control)","ACTIVE_COMPARATOR","Participants assigned to this arm will receive usual clinical care for adult congenital heart disease without the AI-based voice emotion detection-guided counselling intervention.",[19],"Behavioral: Usual Care (Control)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","AI-Based Voice Emotion Detection-Guided Counselling","Participants assigned to the intervention arm will receive an artificial intelligence-based voice emotion detection-guided counselling intervention in addition to usual care. The intervention uses voice recordings collected during structured counselling sessions to analyze emotional features, including emotional valence and arousal, through artificial intelligence-based voice emotion detection algorithms. Based on the analyzed emotional profiles, individualized psychological feedback and counselling guidance are provided to support emotional regulation, stress coping, and adaptive self-management.\n\nThe counselling content is tailored to participants' emotional states and symptom experiences and focuses on reducing psychological distress, improving sleep and fatigue management, enhancing grit, and promoting quality of life. The intervention is delivered by trained healthcare professionals following a standardized protocol, with sessions conducted at predefined intervals during the inter",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Usual Care",[15],{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Yu-Shiu Liu","Assistant Professor","100629821","ai-enabled-frailty-risk-prediction-in-adult-congenital-heart-disease-100629821",false,"NCT07479654","AI-Enabled Frailty Risk Prediction in Adult Congenital Heart Disease","Precision Risk Prediction of Symptom Clusters and Frailty With AI-Guided Emotion Detection: A Three-Year Study in Adults With Congenital Heart Disease","Inclusion Criteria:\n\n1. Adults aged 20 years or older.\n2. Diagnosed with congenital heart disease by a physician.\n3. Able to communicate in Mandarin or Taiwanese, with normal cognitive function.\n\nExclusion Criteria:\n\n1. Presence of other congenital anomalies.\n2. Currently hospitalized for acute decompensation, or having severe cognitive impairment or psychiatric symptoms that preclude completion of questionnaires.\n3. Pregnant individuals.","ALL","20 Years",{"count":44,"type":45},410,"ESTIMATED","INTERVENTIONAL",[48],"NA","The goal of this three-year mixed-methods observational study with an embedded randomized controlled trial is to develop and validate a frailty risk prediction model and evaluate an artificial intelligence-based voice emotion detection-guided counselling intervention in adults with congenital heart disease (ACHD).\n\nThe main questions it aims to answer are:\n\nAre symptom clusters associated with frailty and psychological outcomes in adults with congenital heart disease?\n\nCan symptom clusters and psychosocial factors be used to predict frailty risk over time in ACHD patients?\n\nDoes an AI-based voice emotion detection-guided counselling intervention improve psychological outcomes, fatigue, and quality of life among high-risk ACHD patients?\n\nResearchers will compare ACHD patients receiving AI-based voice emotion detection-guided counselling with those receiving usual care to determine whether the intervention reduces depression, anxiety, sleep disturbance, fatigue, and frailty risk, and improves grit and quality of life.\n\nParticipants will:\n\nComplete longitudinal assessments of symptom clusters, frailty, and psychological status at baseline and follow-up time points\n\nParticipate in qualitative interviews to explore lived experiences related to symptoms and frailty\n\nReceive AI-based voice emotion detection-guided counselling (intervention group only in Year 3)",[51,52,53,54,55],"Adult Congenital Heart Disease","Symptom Clusters","Frailty","Risk Prediction Model","Artificial Intelligence-Based Voice Emotion Detection","NOT_YET_RECRUITING","2026-03-15",{"date":59,"type":60},"2026-03-18","ACTUAL",{"date":62,"type":45},"2026-03-01",{"date":64,"type":45},"2028-12-31",{"name":5,"class":6}]