[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572499":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":48,"studyPopulation":11,"armGroups":49,"interventions":59,"overallOfficials":11,"centralContacts":65,"locations":71,"responsibleParty":88,"collaborators":11,"id":92,"slug":11,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":11,"enrollmentInfo":101,"targetDuration":11,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":74,"whyStopped":11,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Linkoeping University","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death",null,"3 months",[14,17,19,21,23,26,29,33,36],{"measure":15,"description":11,"timeFrame":16},"Total number of acute healthcare visits for heart failure","1 month, 3 months and 6 months",{"measure":18,"description":11,"timeFrame":16},"Total number of unplanned hospitalisations for heart failure",{"measure":20,"description":11,"timeFrame":16},"Total number of all-cause death",{"measure":22,"description":11,"timeFrame":16},"Number of days alive out of hospital",{"measure":24,"description":11,"timeFrame":25},"Changes in NT-proBNP\u002FBNP levels","Baseline, 3 months and 6 months",{"measure":27,"description":28,"timeFrame":25},"Changes in the remote dielectric sensing (ReDS) values","The remote dielectric sensing (ReDS) system (Sensible Medical Innovations Ltd., Netanya, Israel) is a novel electromagnetic energy-based technology that accurately quantifies lung fluid content non-invasively. Normal ReDS values range from 20% to 35%. Values above 35% indicate hypervolemia, while values below 20% suggest dehydration.",{"measure":30,"description":31,"timeFrame":32},"Changes in the 12-item Kansas City Cardiomyopathy Questionnaire scores","The 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated instrument for quantitatively measuring health status for patients with heart failure. It contains four domains: physical limitation, symptom frequency, quality of life, and social limitations. The KCCQ-12 generates both summary and domain scores ranging from 0 to 100, where 0 represents the worst and 100 the best possible health status.","Baseline, 1 month, 3 months and 6 months",{"measure":34,"description":35,"timeFrame":32},"Changes in the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) scores","The 5-level EuroQol-5 Dimension version (EQ-5D-5L) assesses five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. Each dimension is rated on five levels, with higher scores indicating better health-related quality of life.",{"measure":37,"description":38,"timeFrame":32},"Changes in the heart failrue self-care behaviour scores","The European Heart Failure Self-Care Behaviour Scale (EHFScBS) is a 9-item scale, with higher scores indicating poorer self-care (range: 9-45).",[40],{"measure":41,"description":11,"timeFrame":16},"Healthcare costs",{"allocation":43,"interventionModel":44,"interventionModelDescription":11,"primaryPurpose":45,"observationalModel":11,"timePerspective":11,"maskingInfo":46},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":47,"maskingDescription":11,"whoMasked":11},"NONE","Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. Our newly developed ReDS-guided heart failure management program, led by nurses, incorporates algorithms for a follow-up schedule, diuretic adjustments, and symptom monitoring.\n\nThe specific aims of the study are:\n\n1. To examine whether the program decreases the number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death in patients with heart failure.\n2. To evaluate the intervention processes and explore barriers to and facilitators for the implementation of the program.\n\nThis is a multicentre 1:1 randomised controlled clinical trial with a 6-month follow-up. Study participants will be patients with diagnosed with heart failure. The primary outcome will be the total number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisation, and all-cause death at 3 months. Secondary outcomes will include health-related quality of life, self-care behaviour, and healthcare cost. Throughout the randomised controlled trial, a process evaluation will be conducted to assess the fidelity, dose, and reach of the intervention program. Additionally, we will explore both barriers and facilitators for program implementation among study patients and healthcare professionals.",[50,54],{"label":51,"type":52,"description":53,"interventionNames":11},"Usual care group","NO_INTERVENTION","Patients in the usual care group will receive usual care.",{"label":55,"type":56,"description":11,"interventionNames":57},"ReDS-guided heart failure management group","EXPERIMENTAL",[58],"Behavioral: ReDS-guided heart failure management program",[60],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":11},"BEHAVIORAL","ReDS-guided heart failure management program","Remote dielectric sensing (ReDS) system (Sensible Medical Innovations Ltd., Netanya, Israel) is a novel electromagnetic energy-based technology that accurately quantifies changes in lung fluid concentration non-invasively.\n\nPatients in the intervention group will receive a three-month, ReDS-guided heart failure management program in addition to usual care.\n\nThe program, led by nurses, will integrate algorithms for diuretic use, a structured follow-up schedule, and self-care support tailored to pulmonary fluid levels assessed by ReDS.",[55],[66],{"name":67,"role":68,"phone":69,"phoneExt":11,"email":70},"Naoko Perkiö Kato, PhD","CONTACT","+46 (0)11-36 31 17","naoko.perkio.kato@liu.se",[72],{"facility":73,"status":74,"city":75,"state":11,"zip":11,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Primary care center Centrum Flen","RECRUITING","Flen","Sweden","SE",{"type":79,"coordinates":80},"Point",[81,82],16.58781,59.05834,{"lat":82,"lon":81},[85],{"name":86,"role":68,"phone":87,"phoneExt":11,"email":70},"Naoko Perkiö Kato, RN, PhD","+46 11-36 31 17",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Naoko Perkiö Kato","Associate Professor","100572499",false,"NCT06734065","Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care","Effect of Non-Invasive Lung Fluid Monitoring Using ReDS Technology for Heart Failure Management in Primary Care Settings: A Randomized Controlled Trial","LiLAC-HF","Inclusion Criteria:\n\n* Age ≥ 18 years, there is no upper age limit\n* Diagnosed with heart failure regardless of left ventricular ejection fraction\n* Having New York Heart Association (NYHA) Class III\u002FIV irrespective of prior hospitalisation for heart failure, or NYHA II with a history of at least one hospitalisation for heart failure within the previous 12 months\n* Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) within 12 months: (a) ≥450 pg\u002Fml for patients under 50 years; (b) ≥900 pg\u002Fml for patients aged 50-75 years; (c) ≥1800 pg\u002Fml for patients over 75 years.\n\nExclusion Criteria:\n\n* NYHA I\n* Life expectancy \\\u003C6 months\n* Physical characteristics that prevented use of the ReDS (body mass index \\\u003C 22 or \\>39, and height less than 155 cm or higher than 195 cm)\n* Implantation of a left ventricular assist device or cardiac transplantation.","ALL","18 Years",{"count":102,"type":103},330,"ESTIMATED","INTERVENTIONAL",[106],"NA","Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. This randomized controlled trial aims to evaluate the effectiveness and processes of the ReDS-guided heart failure management program in primary care settings for patients with heart failure.",[109],"Heart Failure",[111,112,113,114,115,116],"Heart failure","Primary care","Nursing","Monitoring","Self-care","Community","2025-04-23",{"date":119,"type":120},"2025-04-27","ACTUAL",{"date":122,"type":120},"2025-04-16",{"date":124,"type":103},"2030-12",{"name":5,"class":6},1]