[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659248":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":39,"overallOfficials":49,"centralContacts":54,"locations":59,"responsibleParty":90,"collaborators":13,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":13,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":13,"enrollmentInfo":101,"targetDuration":13,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":62,"whyStopped":13,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Chang Gung University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Social Frailty Score","Change in social frailty will be assessed using the five-item Makizako Social Frailty Index. Scores will be compared across the AI conversational support group, community social participation group, and control group.","Baseline and 1, 3, 6, and 12 months after intervention",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"NON_RANDOMIZED","PARALLEL","This study uses a three-arm parallel design to evaluate an AI-based conversational social-support intervention among older adults with heart failure. A total of 174 participants are planned for the intervention phase, with 58 participants in each group. Participants will be followed to assess changes in social frailty and related outcomes.","SUPPORTIVE_CARE",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","This study combines an initial cross-sectional assessment with an embedded intervention trial and longitudinal follow-up.\n\nPhase 1: Baseline assessment\n\nClinical information and standardized assessments will be collected to examine gender differences in sarcopenia, physical activity, and multidimensional frailty among older adults with chronic heart failure. Structural equation modeling will be used to investigate factors and pathways associated with social frailty.\n\nPhase 2: Intervention\n\nThe protocol plans to enroll 174 participants in three groups of 58:\n\n1. AI-Based Conversational Social-Support Intervention: Participants will be instructed to use an AI-based conversational application for 15-30 minutes daily. The intervention includes conversational support and emotional monitoring. Training, language support, and tablets or internet connectivity will be provided when needed.\n2. Community Social Participation: Participants will be encouraged to attend regular social activities to enhance social interaction, with continued care and telephone follow-up.\n3. Control: Participants will maintain their routine activities.\n\nClinical and questionnaire-based assessments will be conducted before and after the intervention to evaluate changes in emotional state, physical activity, social frailty, and other health outcomes.\n\nPhase 3: Longitudinal follow-up\n\nFollow-up assessments are planned at 1, 3, 6, and 12 months after the intervention to examine the sustainability of intervention effects and potential gender differences. Assessments include standardized questionnaires and relevant clinical measures.",[23,29,35],{"label":24,"type":25,"description":26,"interventionNames":27},"AI Conversational Support Group","EXPERIMENTAL","Participants in this group will receive an AI-based conversational social-support intervention delivered via a tablet.",[28],"Behavioral: AI-Based Conversational Social Support",{"label":30,"type":31,"description":32,"interventionNames":33},"Community Social Participation Group","ACTIVE_COMPARATOR","Participants in this group will be encouraged to attend regular community social activities to enhance social interaction. Care and follow-up will also be provided by telephone.",[34],"Behavioral: Community Social Participation",{"label":36,"type":37,"description":38,"interventionNames":13},"Control Group","NO_INTERVENTION","Participants in this group will maintain their routine activities without receiving the AI-based conversational social-support intervention or the community social participation intervention.",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":13},"BEHAVIORAL","AI-Based Conversational Social Support","Participants will receive an AI-based conversational social-support intervention delivered via a tablet. The intervention is designed to provide social interaction and support for older adults with heart failure.",[24],{"type":41,"name":46,"description":47,"armGroupLabels":48,"otherNames":13},"Community Social Participation","Participants will be encouraged to attend regular community social activities to enhance social interaction, with continued care and follow-up by telephone.",[30],[50],{"name":51,"affiliation":52,"role":53},"Jeng Wang, PhD","Chang Gung University of Science and Technology, Department of Nursing","PRINCIPAL_INVESTIGATOR",[55],{"name":51,"role":56,"phone":57,"phoneExt":13,"email":58},"CONTACT","+886 03-2118999#3435","jengwang@mail.cgust.edu.tw",[60,78],{"facility":61,"status":62,"city":63,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"New Taipei Municipal Tucheng Hospital (Built and Operated by Chang Gung Medical Foundation)","RECRUITING","New Taipei City","236","Taiwan","TW",{"type":68,"coordinates":69},"Point",[70,71],121.45703,25.06199,{"lat":71,"lon":70},[74],{"name":75,"role":56,"phone":76,"phoneExt":13,"email":77},"Ko-Hsuan Hu, MS","+886 03-2118999#3211","khhu@mail.cgust.edu.tw",{"facility":79,"status":62,"city":80,"state":81,"zip":82,"country":65,"countryCode":66,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Chang Gung Memorial Hospital, Linkou","Taoyuan","Taoyuan City","333",{"type":68,"coordinates":84},[85,86],121.29696,24.99368,{"lat":86,"lon":85},[89],{"name":75,"role":56,"phone":76,"phoneExt":13,"email":77},{"type":91,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659248","ai-based-conversational-social-support-for-older-adults-with-heart-failure-100659248",false,"NCT07862933","AI-Based Conversational Social Support for Older Adults With Heart Failure","Gendered Psychosocial Pathways of Social Frailty in Older Adults With Heart Failure: A Longitudinal Study of an AI-Based Conversational Social-Support Intervention.","Inclusion Criteria:\n\n1. Participants aged 60 years or older.\n2. Diagnosis of chronic heart failure (CHF).\n3. Ability to communicate effectively in Mandarin or Taiwanese.\n\nExclusion Criteria:\n\n1. Unstable heart failure.\n2. Severe comorbidities, such as end-stage renal disease, advanced hepatic dysfunction, or terminal malignancies.\n3. Severe cognitive deficits that impede the ability to provide informed consent or participate in study interventions.\n4. Uncorrected visual or hearing impairments that hinder effective communication or interaction with the AI-based conversational social-support intervention.\n5. Active psychiatric conditions, including major depression or psychosis, that could interfere with study participation or adherence.","ALL","60 Years",{"count":102,"type":103},174,"ESTIMATED","INTERVENTIONAL",[106],"NA","This three-year study aims to investigate gender differences in social frailty and evaluate the effects of an artificial intelligence (AI)-based conversational social-support intervention among older adults with chronic heart failure (CHF).\n\nThe study plans to enroll 300-500 adults aged 60 years or older from four Chang Gung Memorial Hospital branches in Taiwan.\n\nIn the first phase, researchers will assess participants' clinical characteristics, sarcopenia, physical activity, and physical, psychological, and social frailty. The study will examine gender differences and identify factors associated with social frailty.\n\nIn the second phase, 174 participants are planned to be assigned to three groups: an AI-based conversational social-support group, a community social participation group, and a control group. The AI group will engage in daily 15-30-minute app-based conversations, while the community group will be encouraged to participate in regular social activities. The control group will maintain routine activities.\n\nThe third phase will assess longer-term changes in social frailty, emotional well-being, physical activity, and health outcomes, with follow-up assessments at 1, 3, 6, and 12 months after the intervention.",[109,110,111],"Heart Failure","Social Frailty","Sarcopenia",[113,114,115,116,117,118,119,120],"Chronic Heart Failure","Gender Differences","Artificial Intelligence","Conversational Social Support","Frailty","Physical Activity","Older Adults","Longitudinal Study","2026-10-02",{"date":123,"type":124},"2026-10-07","ACTUAL",{"date":126,"type":124},"2025-11-05",{"date":128,"type":103},"2028-07-31",{"name":5,"class":6},2]