[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563783":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":31,"studyPopulation":22,"armGroups":32,"interventions":45,"overallOfficials":52,"centralContacts":57,"locations":67,"responsibleParty":89,"collaborators":92,"id":95,"slug":22,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":22,"enrollmentInfo":103,"targetDuration":22,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":22,"overallStatus":70,"whyStopped":22,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"National University of Ireland, Galway, Ireland","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Reduction in re-admission rates","Whether a follow-up with virtual wards reduces HF hospitalisation at three whether a follow up with virtual wards reduces HF hospitalisation at three months follow-up","three months",[14,18],{"measure":15,"description":16,"timeFrame":17},"All cause mortality","Whether HF virtual wards reduces all cause mortality","12 months",{"measure":19,"description":20,"timeFrame":21},"Financial Cost of virtual ward in comparison to the standard care","Analysis of the financial implications of using the virtual heart failure ward in comparison to the cost of standard heart failure care","3 months",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":22,"timePerspective":22,"maskingInfo":28},"RANDOMIZED","PARALLEL","Randomised controlled trial. half of the participants will be in the tele monitoring group while the other half will be in the current standard of care group","SUPPORTIVE_CARE",{"masking":29,"maskingDescription":30,"whoMasked":22},"NONE","the participants will be randomised using REDCAP software but there will be no masking performed","This is a randomized, controlled, multicentre, parallel-group trial in which we will consecutively include all patients over 18 years of age with a recent hospitalisation due to decompensated HF and randomise them to usual care vs. telemedicine follow-up. Any stay in the emergency department or ward for over 24 hours that required treatment with intravenous diuretic will be considered an hospitalisation.\n\nThe heart failure diagnosis will be made according to the 2021 ESC Heart Failure Guidelines.\n\nThe study will be registered at ClinicalTrials.gov. The study will be guided by good clinical practice (GCP), in accordance with the Declaration of Helsinki and the laws and regulations applicable in Ireland. Written approval from the appropriate Ethics Committees will be required, and each patient will provide written informed consent before enrolling in the study.\n\nPatients will be recruited from the participant hospitals (Portiuncula University Hospital and Galway University Hospital).\n\nInclusion criteria: The study will include adult patients (≥ 18 years) with a recent hospitalisation. We will include all ranges of ejection fraction, and also patients with known and de novo heart failure.\n\nThe main exclusion criteria will be:\n\n* Patients who decline to participate in the study.\n* Patient in palliative care or with a life expectancy of less than one year.\n* Patients referred to skilled nursing facilities or nursing homes at hospital discharge.\n* Patients with planned intervention on the mitral or aortic valve during admission or scheduled early after discharge.\n* Planned haemodialysis.\n* Patients included in other randomized controlled trials.\n* Patients who, at the investigator's discretion, are considered unable to participate in the study, mainly due to a previous history of non-compliance with medication and follow-up appointments, language barrier, or moderate or severe cognitive impairment without the support of a family member\u002Fcaregiver.\n* Patients with asymptomatic (NYHA class I) left ventricular dysfunction, usually in the setting of an acute myocardial infarction.\n\nThe lack of information technology (IT) literacy will not be an exclusion criterion.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Standard Care","ACTIVE_COMPARATOR","All patients with a recent admission for decompensated heart failure are seen in a first face-to-face appointment within two weeks of discharge as per current 2021 ESC Heart Failure Guidelines.\n\nThe standard care group will receive the usual nurse lead structured follow up and patients in the usual care will have a face-to-face appointment at week 6 and 12, and all the other contacts will be phone calls or face-to-face",[38],"Other: Standard Care",{"label":40,"type":41,"description":42,"interventionNames":43},"Telemonitoring","EXPERIMENTAL","After the initial face-to-face appointment the telemonitoring group will have appointments at week 4 (phone call or videoconference), week 6 (videoconference), week 8 (phone call or videoconference) and week 12 (videoconference). In total, the patients will have 6 structured appointments.\n\nExtra phone calls, videoconferences, and face-to-face visits will be made at any time, depending on the patient's needs, irrespective of the assigned group.\n\nPatients assigned to the intervention group will receive a tablet (if the patients do not have a tablet, computer or smartphone), a weight scale and a blood pressure monitor. The patients will provide daily biometric data (weight, heart rate and blood pressure) and report symptoms through four questions to capture worsening symptoms of the cardiac condition.\n\nThe system will generate warning alarms (biometrics out of range or symptom reporting) and alerts (information related to the function of the household devices).",[44],"Other: Telemonitoring",[46,49],{"type":6,"name":40,"description":47,"armGroupLabels":48,"otherNames":22},"Patients assigned to the intervention group will receive a tablet (if the patients do not have a tablet, computer or smartphone), a weight scale and a blood pressure monitor. The patients will provide daily biometric data (weight, heart rate and blood pressure) and report symptoms through four questions to capture worsening symptoms of the cardiac condition.",[40],{"type":6,"name":34,"description":50,"armGroupLabels":51,"otherNames":22},"patients with a recent admission for heart failureare seen in a first face-to-face appointment within two weeks of discharge as per current 2021 ESC Heart Failure Guidelines with face-to-face follow up at 6 and 12 weeks.",[34],[53],{"name":54,"affiliation":55,"role":56},"Derek O'Keeffe, MD, PhD","Galway University Hospitals\u002FUniversity of Galway","PRINCIPAL_INVESTIGATOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":22,"email":62},"David Tiernan, MD","CONTACT","+353 861735800","david.tiernan@universityofgalway.ie",{"name":64,"role":60,"phone":65,"phoneExt":22,"email":66},"Nuria Farre, MD, PhD","+35390 964 8200","nuria.farre@hse.ie",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Portiuncula University Hospital","RECRUITING","Ballinasloe","Galway","H53 T971","Ireland","IE",{"type":77,"coordinates":78},"Point",[79,80],-8.21944,53.3275,{"lat":80,"lon":79},[83,85,87],{"name":64,"role":60,"phone":84,"phoneExt":22,"email":66},"+353090 964 8200",{"name":59,"role":60,"phone":86,"phoneExt":22,"email":62},"+353861735800",{"name":88,"role":56,"phone":22,"phoneExt":22,"email":22},"Derek O'Keeffe, MD, PhD",{"type":56,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Derek O'Keeffe","Principal Investigator",[93],{"name":94,"class":6},"Health Service Executive, Ireland","100563783",false,"NCT06620653","Heart Failure Virtual Ward Research Study","HF-VW","Inclusion Criteria:\n\n* Adult patients (≥ 18 years) with a recent hospitalisation.\n* Known ejection fraction and NYHA Class\n* Known or de novo Heart Failure\n* Patient or carer able to speak and understand English\u002FIrish\n* Willing to participate in the study.\n* Within catchment area of the Saolta group.\n\nExclusion Criteria:\n\n* Patients who decline to participate in the study.\n* Patient in palliative care or with a life expectancy of less than one year.\n* Patients referred to skilled nursing facilities or nursing homes at hospital discharge.\n* Patients with planned intervention on the mitral or aortic valve during admission or scheduled early after discharge.\n* Planned haemodialysis.\n* Patients included in other randomized controlled trials.\n* Patients who, at the investigator's discretion, are considered unable to participate in the study, mainly due to a previous history of non- compliance with medication and follow-up appointments, language barrier, or moderate or severe cognitive impairment without the support of a family member\u002Fcaregiver.\n* Patients with asymptomatic (NYHA class I) left ventricular dysfunction, usually in the setting of an acute myocardial infarction.\n* The lack of information technology (IT) literacy will not be an exclusion criterion.","ALL","18 Years",{"count":104,"type":105},346,"ESTIMATED","INTERVENTIONAL",[108],"NA","The main aim will be to evaluate whether a follow-up with virtual wards reduces HF hospitalisation at three months follow-up. Hospital admission will be defined as any hospital admission, or an emergency room stay of more than 24 h requiring IV diuretics.\n\nThe secondary objectives will be to evaluate whether this intervention reduces all-cause mortality, all-cause hospitalisation at three months, is cost-effectiveness, is associated with a higher percentage of prescription and dose of prognostic medication and improves the quality of life. To assess the potential long-term effects of the virtual wards follow-up, we will evaluate whether this intervention reduces all-cause mortality and HF hospitalisation at 6- and 12-months by a telephone call\u002Fvirtual outpatients' appointment.\n\nThe study outcomes will be ascertained at each visit. Given the study design, it is impossible to assess the endpoints in a blinded manner. Clinical events during the study will be adjudicated by an operational committee whose members will be unaware of the group assignment.",[111],"Heart Failure","2026-04-10",{"date":114,"type":115},"2026-04-15","ACTUAL",{"date":117,"type":115},"2024-10-18",{"date":119,"type":105},"2027-05",{"name":5,"class":6},1]