[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597983":3},{"organization":4,"armGroups":7,"interventions":49,"overallOfficials":83,"centralContacts":91,"locations":54,"responsibleParty":100,"collaborators":103,"id":106,"slug":54,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":54,"enrollmentInfo":115,"targetDuration":54,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":131,"whyStopped":54,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":54},{"fullName":5,"class":6},"UMC Utrecht","OTHER",[8,14,19,24,29,34,39,44],{"label":9,"type":10,"description":11,"interventionNames":12},"Condition 1","EXPERIMENTAL","Module 1: Low version; Module 2: Low version; Module 3: Low version",[13],"Other: STAR condition 1",{"label":15,"type":10,"description":16,"interventionNames":17},"Condition 2","Module 1: Low version; Module 2: Low version; Module 3: High version",[18],"Other: STAR condition 2",{"label":20,"type":10,"description":21,"interventionNames":22},"Condition 3","Module 1: Low version; Module 2: High version; Module 3: High version",[23],"Other: STAR condition 3",{"label":25,"type":10,"description":26,"interventionNames":27},"Condition 4","Module 1: Low version; Module 2: High version; Module 3: Low version",[28],"Other: STAR condition 4",{"label":30,"type":10,"description":31,"interventionNames":32},"Condition 5","Module 1: High version; Module 2: Low version; Module 3: Low version",[33],"Other: STAR condition 5",{"label":35,"type":10,"description":36,"interventionNames":37},"Condition 6","Module 1: High version; Module 2: Low version; Module 3: High version",[38],"Other: STAR condition 6",{"label":40,"type":10,"description":41,"interventionNames":42},"Condition 7","Module 1: High version; Module 2: High version; Module 3: Low version",[43],"Other: STAR condition 7",{"label":45,"type":10,"description":46,"interventionNames":47},"Condition 8","Module 1: High version; Module 2: High version; Module 3: High version",[48],"Other: STAR condition 8",[50,55,59,63,67,71,75,79],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"STAR condition 1","* Basic module: HF information and doing symptom awareness exercises.\n* Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse\n* Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse\n* Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Written feedback HF nurse",[9],null,{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":54},"STAR condition 2","Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse",[15],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":54},"STAR condition 3","Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse",[20],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":54},"STAR condition 4","Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Written feedback HF nurse",[25],{"type":6,"name":68,"description":69,"armGroupLabels":70,"otherNames":54},"STAR condition 5","Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; written feedback HF nurse",[30],{"type":6,"name":72,"description":73,"armGroupLabels":74,"otherNames":54},"STAR condition 6","Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse",[35],{"type":6,"name":76,"description":77,"armGroupLabels":78,"otherNames":54},"STAR condition 7","Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Written feedback HF nurse",[40],{"type":6,"name":80,"description":81,"armGroupLabels":82,"otherNames":54},"STAR condition 8","Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse",[45],[84,87],{"name":85,"affiliation":5,"role":86},"Heleen Westland, PhD","PRINCIPAL_INVESTIGATOR",{"name":88,"affiliation":89,"role":90},"Tiny Jaarsma, PhD","UMC Utrecht and Linköping University","STUDY_CHAIR",[92,97],{"name":93,"role":94,"phone":95,"phoneExt":54,"email":96},"Michelle van Rijn, MSc","CONTACT","0031646927611","m.m.vanrijn-3@umcutrecht.nl",{"name":85,"role":94,"phone":98,"phoneExt":54,"email":99},"0031631119465","h.westland@umcutrecht.nl",{"type":86,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"H.Westland","Dr.",[104],{"name":105,"class":6},"Dutch Heart Foundation","100597983",false,"NCT07065578","Optimization of STAR","Optimization of the STAR Intervention on Self-care Symptom Management in Patients With Heart Failure","STAR","Inclusion Criteria:\n\n* Diagnosed with HF (irrespective of ejection fraction) and symptomatic NYHA class II or III.\n* 18 years or older.\n* Willing and able to provide written informed consent.\n* Life expectancy \\>6 months.\n* Optimal medical HF treatment following ESC HF guidelines (i.e. 'patients with stable HF').\n\nExclusion Criteria:\n\n* Participants living in a care facility (e.g. nursing home, revalidation center).\n* Language barrier preventing sufficient understanding and communication in Dutch.\n* Participants who are hospitalized during inclusion.","ALL","18 Years",{"count":116,"type":117},320,"ESTIMATED","INTERVENTIONAL",[120],"NA","The aim of this study is optimize the STAR (SympTom mAnagement self-caRe) intervention to support patients with HF in staying healthy, and particularly in self-monitoring and managing symptoms. The STAR intervention includes promising components aiming at improving patient outcomes in terms of interference of bothersome symptoms, self-care, quality of life (QoL) and healthcare utilization.\n\nIn this study, the intervention components are tested in an optimization trial in 320 patients with HF from 8 HF clinics in the Netherlands. This study will result in an optimized STAR intervention, composed of the best components, that is effective, scalable, and efficient to improve patient outcomes and can be used in HF clinics.",[123,124],"Heart Failure NYHA Class II","Heart Failure NYHA Class III",[126,127,128,129,130],"Heart Failure","Self-management","symptom management","Self-care","e-Health","NOT_YET_RECRUITING","2025-07-03",{"date":134,"type":135},"2025-07-15","ACTUAL",{"date":137,"type":117},"2025-07",{"date":139,"type":117},"2027-03-31",{"name":5,"class":6}]