[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433628":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":49,"studyPopulation":43,"armGroups":50,"interventions":63,"overallOfficials":77,"centralContacts":82,"locations":87,"responsibleParty":302,"collaborators":43,"id":306,"slug":307,"hasResults":308,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":308,"sex":314,"minAge":315,"maxAge":43,"enrollmentInfo":316,"targetDuration":43,"studyType":319,"phases":320,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":90,"whyStopped":43,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":340},{"fullName":5,"class":6},"Kantonsspital Aarau","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":28},[9],{"measure":10,"description":10,"timeFrame":11},"time to death from any cause (i.e., all-cause mortality)","Enrollment to 3 years",[13,16,19,22,25],{"measure":14,"description":14,"timeFrame":15},"Time to non-elective hospital readmission after discharge from the index hospital stay","assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]",{"measure":17,"description":18,"timeFrame":15},"Time to the first major complication","time to the first major complication including death, bacterial infection with need for antibiotic treatment, major cardiovascular event (i.e., stroke, intracranial bleeding, cardiac arrest, myocardial infarction) or pulmonary embolism, acute renal failure, gastro-intestinal events (including hemorrhage, intestinal perforation, acute pancreatitis)",{"measure":20,"description":21,"timeFrame":15},"Changes in functional status measured by the Barthel's index","Changes in functional status measured by the Barthel's index (scores range from 0 to 100, with higher scores indicating better functional status)",{"measure":23,"description":24,"timeFrame":15},"Changes in quality of life measured with the European Quality of Life 5 Dimensions index (German Version, EQ-5D index)","Changes in quality of life measured with the European Quality of Life 5 Dimensions index (German Version, EQ-5D index values range from 0 to 1, with higher scores indicating better quality of life)",{"measure":26,"description":27,"timeFrame":15},"Changes in quality of life measured with the visual-analogue scale (EQ-5D VAS)","Changes in quality of life measured with the visual-analogue scale (EQ-5D VAS) (scores range from 0 to 100, with higher scores indicating better health status).",[29,32,34,36],{"measure":30,"description":30,"timeFrame":31},"Change in body weight","assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits",{"measure":33,"description":33,"timeFrame":31},"Change in calf circumference to assess muscle mass",{"measure":35,"description":35,"timeFrame":31},"Change in bioelectrical impedance analysis (BIA) to assess body composition",{"measure":37,"description":37,"timeFrame":31},"Change in hand grip by means of handgrip strength through dynamometry (North Coast Medical Exacta™ Hydraulic Hand Dynamometer) to assess muscle strength",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":43,"timePerspective":43,"maskingInfo":44},"RANDOMIZED","PARALLEL","Pragmatic, single blinded, open label randomised-controlled trial","TREATMENT",null,{"masking":45,"maskingDescription":46,"whoMasked":47},"SINGLE","This trial is single blinded (regarding outcome assessment)",[48],"OUTCOMES_ASSESSOR","Malnutrition is a strong and independent long-term risk factor for mortality, rehospitalisation and functional decline, particularly in the elderly, polymorbid medical patient population. The randomized-controlled Effect of early nutritional support on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial (EFFORT, Lancet 2019) included 2028 patients in eight Swiss hospitals and found that nutritional support during the inhospital stay reduces very efficiently the risk for complications and mortality with numbers needed to treat (NNT) of 23 and 37, respectively.\n\nYet, the nutritional intervention was not continued after hospital discharge of patients and long-term follow-up data of patients showed a lack of sustained effect of the initial nutritional support strategy. There is a current lack of trial data investigating whether long-term use of nutritional support has a sustained effect on clinical outcomes in this patient population. This study is to compare the continuous use of nutritional support with the use of approved oral nutritional supplements to reach protein and energy goals and to analyze whether medical patients at nutritional risk show a sustained benefit from long-term nutritional support after hospital discharge, and why and how nutritional support affects the course of disease from a mechanistic physio-pathological standpoint.",[51,58],{"label":52,"type":53,"description":54,"interventionNames":55},"Intervention group: individualized nutritional support","EXPERIMENTAL","Intervention group patients will receive individualized nutritional support to reach energy and protein goals with the support of an experienced, unblinded dietician and with use of oral nutritional supplements (ONS) as needed",[56,57],"Dietary Supplement: nutritional supplement","Other: individualized nutritional guidelines",{"label":59,"type":6,"description":60,"interventionNames":61},"Control group: general information on healthy food habits","Control group patients will receive nutritional counselling (general information on healthy food habits) at discharge, but no nutritional support strategy will be used during follow-up",[62],"Other: general nutritional information",[64,69,73],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":43},"DIETARY_SUPPLEMENT","nutritional supplement","daily use of one or more specific oral nutritional supplement with high energy\u002Fprotein content (i.e., Resource Ultra, Resource 2.0 (Fibre), Resource Ultra Fruit).",[52],{"type":6,"name":70,"description":71,"armGroupLabels":72,"otherNames":43},"individualized nutritional guidelines","nutritional plan supervised by an experienced study dietician based on the usual home nutrition with possibility to increase intake by adaptation to patient preferences, between meal snaking and food enrichment\u002Ffortification. Every 2-4 weeks phone call by unblinded study dietician to follow nutritional intervention.",[52],{"type":6,"name":74,"description":75,"armGroupLabels":76,"otherNames":43},"general nutritional information","general information about health food behavior upon hospital discharge",[59],[78],{"name":79,"affiliation":80,"role":81},"Philipp Schuetz, Prof. Dr. med.","Kantonsspital Aarau, University Department of Internal Medicine","PRINCIPAL_INVESTIGATOR",[83],{"name":79,"role":84,"phone":85,"phoneExt":43,"email":86},"CONTACT","+41 (0) 62 838 9524","Philipp.Schuetz@unibas.ch",[88,104,116,128,140,152,164,177,187,202,218,232,256,264,272,281,290,296],{"facility":89,"status":90,"city":91,"state":43,"zip":43,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Hospital Universitari Vall Hebron de Barcelona","RECRUITING","Barcelona","Spain","ES",{"type":95,"coordinates":96},"Point",[97,98],2.15899,41.38879,{"lat":98,"lon":97},[101],{"name":102,"role":84,"phone":43,"phoneExt":43,"email":103},"Rosa Burgos Peláez, Dr. med.","rosa.burgos@vallhebron.cat",{"facility":105,"status":90,"city":106,"state":43,"zip":43,"country":92,"countryCode":93,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Hospital Universitario de Getafe","Getafe",{"type":95,"coordinates":108},[109,110],-3.73295,40.30571,{"lat":110,"lon":109},[113],{"name":114,"role":84,"phone":43,"phoneExt":43,"email":115},"Leocardio Rodríguez Mañas, Dr. med.","leocadio.rodriguez@salud.madrid.org",{"facility":117,"status":90,"city":118,"state":43,"zip":43,"country":92,"countryCode":93,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Complejo AComplejo Asistencial Universitario de León","León",{"type":95,"coordinates":120},[121,122],-5.57032,42.60003,{"lat":122,"lon":121},[125],{"name":126,"role":84,"phone":43,"phoneExt":43,"email":127},"María Ballesteros, Dr. med.","mdballesteros@telefonica.net",{"facility":129,"status":90,"city":130,"state":43,"zip":43,"country":92,"countryCode":93,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Hospital U. Gregorio Marañón de Madrid","Madrid",{"type":95,"coordinates":132},[133,134],-3.70256,40.4165,{"lat":134,"lon":133},[137],{"name":138,"role":84,"phone":43,"phoneExt":43,"email":139},"Christina Cuerda, Dr. med.","cuerda.cristina@gmail.com",{"facility":141,"status":90,"city":142,"state":43,"zip":43,"country":92,"countryCode":93,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Hospital Universitario Regional de Málaga","Málaga",{"type":95,"coordinates":144},[145,146],-4.42034,36.72016,{"lat":146,"lon":145},[149],{"name":150,"role":84,"phone":43,"phoneExt":43,"email":151},"Gabriel Olveira Fuster, Dr. med.","gabrielm.olveira.sspa@juntadeandalucia.es",{"facility":153,"status":90,"city":154,"state":43,"zip":43,"country":92,"countryCode":93,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Hospital Clínico Universitario de Valladolid","Valladolid",{"type":95,"coordinates":156},[157,158],-4.72353,41.65541,{"lat":158,"lon":157},[161],{"name":162,"role":84,"phone":43,"phoneExt":43,"email":163},"Daniel de Luis Román, Dr. med.","dluisro@saludcastillayleon.es",{"facility":165,"status":166,"city":167,"state":168,"zip":169,"country":170,"countryCode":171,"cosmosGeoPoint":172,"geoPoint":176,"contacts":43},"Spital Zofingen","COMPLETED","Zofingen","Canton of Aargau","4800","Switzerland","CH",{"type":95,"coordinates":173},[174,175],7.94586,47.28779,{"lat":175,"lon":174},{"facility":178,"status":166,"city":179,"state":180,"zip":181,"country":170,"countryCode":171,"cosmosGeoPoint":182,"geoPoint":186,"contacts":43},"Spital Emmental Burgdorf","Burgdorf","Canton of Bern","3400",{"type":95,"coordinates":183},[184,185],7.62786,47.05901,{"lat":185,"lon":184},{"facility":188,"status":90,"city":189,"state":180,"zip":190,"country":170,"countryCode":171,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Spital Thun","Thun","3600",{"type":95,"coordinates":192},[193,194],7.62166,46.75118,{"lat":194,"lon":193},[197,201],{"name":198,"role":84,"phone":199,"phoneExt":43,"email":200},"Thomas Zehnder, Dr. med.","+41 33 226 26 49","thomas.zehnder@spitalstsag.ch",{"name":198,"role":81,"phone":43,"phoneExt":43,"email":43},{"facility":203,"status":90,"city":204,"state":205,"zip":206,"country":170,"countryCode":171,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Spital Lachen","Lachen","Canton of Schwyz","8853",{"type":95,"coordinates":208},[209,210],8.85324,47.19224,{"lat":210,"lon":209},[213,217],{"name":214,"role":84,"phone":215,"phoneExt":43,"email":216},"Thomas Bregenzer, Dr. med.","+41 55 451 31 03","thomas.bregenzer@spital-lachen.ch",{"name":214,"role":81,"phone":43,"phoneExt":43,"email":43},{"facility":219,"status":90,"city":220,"state":221,"zip":222,"country":170,"countryCode":171,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Kantonsspital Münsterlingen","Münsterlingen","Thurgau","8596",{"type":95,"coordinates":224},[225,226],9.23271,47.63197,{"lat":226,"lon":225},[229,231],{"name":230,"role":84,"phone":43,"phoneExt":43,"email":43},"Vojtech Pavlicek, Dr. med.",{"name":230,"role":81,"phone":43,"phoneExt":43,"email":43},{"facility":80,"status":90,"city":233,"state":43,"zip":234,"country":170,"countryCode":171,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Aarau","5001",{"type":95,"coordinates":236},[237,238],8.04422,47.39254,{"lat":238,"lon":237},[241,242,243,246,248,250,252,254],{"name":79,"role":84,"phone":85,"phoneExt":43,"email":86},{"name":79,"role":81,"phone":43,"phoneExt":43,"email":43},{"name":244,"role":245,"phone":43,"phoneExt":43,"email":43},"Beat Mueller, Prof. Dr. med","SUB_INVESTIGATOR",{"name":247,"role":245,"phone":43,"phoneExt":43,"email":43},"Nina Kägi-Braun, Dr. med.",{"name":249,"role":245,"phone":43,"phoneExt":43,"email":43},"Pascal Tribolet",{"name":251,"role":245,"phone":43,"phoneExt":43,"email":43},"Manuela Deiss",{"name":253,"role":245,"phone":43,"phoneExt":43,"email":43},"T Ehmann, Dr. med.",{"name":255,"role":245,"phone":43,"phoneExt":43,"email":43},"Carla Wunderle, PhD",{"facility":257,"status":166,"city":258,"state":43,"zip":43,"country":170,"countryCode":171,"cosmosGeoPoint":259,"geoPoint":263,"contacts":43},"Bern University Hospital, Department of General Internal Medicine","Bern",{"type":95,"coordinates":260},[261,262],7.44744,46.94809,{"lat":262,"lon":261},{"facility":265,"status":166,"city":266,"state":43,"zip":43,"country":170,"countryCode":171,"cosmosGeoPoint":267,"geoPoint":271,"contacts":43},"Kantonsspital Lucerne, Department of Internal Medicine","Lucerne",{"type":95,"coordinates":268},[269,270],8.30635,47.05048,{"lat":270,"lon":269},{"facility":273,"status":166,"city":274,"state":43,"zip":275,"country":170,"countryCode":171,"cosmosGeoPoint":276,"geoPoint":280,"contacts":43},"Kantonsspital Sankt Gallen","Sankt Gallen","9007",{"type":95,"coordinates":277},[278,279],9.37477,47.42391,{"lat":279,"lon":278},{"facility":282,"status":166,"city":283,"state":43,"zip":284,"country":170,"countryCode":171,"cosmosGeoPoint":285,"geoPoint":289,"contacts":43},"Klinik Hirslanden Zürich","Zurich","8032",{"type":95,"coordinates":286},[287,288],8.55,47.36667,{"lat":288,"lon":287},{"facility":291,"status":166,"city":283,"state":43,"zip":292,"country":170,"countryCode":171,"cosmosGeoPoint":293,"geoPoint":295,"contacts":43},"Stadtspital Zürich","8063",{"type":95,"coordinates":294},[287,288],{"lat":288,"lon":287},{"facility":297,"status":166,"city":283,"state":43,"zip":298,"country":170,"countryCode":171,"cosmosGeoPoint":299,"geoPoint":301,"contacts":43},"Universitätsspital Zürich","8091",{"type":95,"coordinates":300},[287,288],{"lat":288,"lon":287},{"type":303,"investigatorFullName":304,"investigatorTitle":305,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Philipp Schuetz","Prof. Dr. med.","100433628","effect-of-continued-nutritional-support-at-hospital-discharge-on-mortality-frailty-functional-outcomes-and-recovery-100433628",false,"NCT04926597","Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery","Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery Trial: The EFFORT II Project","EFFORT II","Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Adult (age ≥18 years), medical patients\n* Nutritional risk screening using the Nutritional Risk Screening (NRS): total score ≥3 points consisting of ≥1 points for impairment of the nutritional status \\[weight loss \\>5% in 3 month or food intake of 50-75% in the last week before hospital admission\\] plus ≥1 for the severity of the disease (i.e., cancer, chronic kidney disease, chronic heart failure, COPD) and other chronic diseases according to the definition of the \"National Center for Chronic Disease Prevention and Health Promotion\": Chronic diseases are defined broadly as conditions that last 1 year or more and require ongoing medical attention or limit activities of daily living or both .\n\nExclusion Criteria:\n\n* after surgery\n* unable to ingest oral nutrition\n* need for long-term nutrition,\n* terminal condition\n* acute pancreatitis or acute liver failure\n* patients discharged to a nursing home\n* patients unlikely to comply with nutritional support treatment (e.g., dementia)\n* COVID-Hospitalisation requiring intensive care","ALL","18 Years",{"count":317,"type":318},1200,"ESTIMATED","INTERVENTIONAL",[321],"NA","This study is to compare the sustained post-discharge nutritional support to reach individual energy and protein goals to usual care home nutrition in medical patients at nutritional risk.",[324],"Malnutrition",[326,327,328,329,330],"Nutritional Support","Oral Nutritional Supplements","Frailty","Mortality","Morbidity","2024-11-18",{"date":333,"type":334},"2024-11-20","ACTUAL",{"date":336,"type":334},"2021-08-05",{"date":338,"type":318},"2026-12",{"name":304,"class":6},18]