[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643589":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":33,"locations":43,"responsibleParty":130,"collaborators":12,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":134,"sex":140,"minAge":141,"maxAge":12,"enrollmentInfo":142,"targetDuration":12,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":163,"whyStopped":12,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care","NO_INTERVENTION","Participants randomized to the usual care arm will recieve standard clinical care as provided during routine hospital practice for inpatients with signs of harmful alcohol use.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Elastography-based brief alcohol intervention","ACTIVE_COMPARATOR","Participants randomized to the elastography-based brief alcohol intervention groupe, will, in addition to usual care, recieve liver stifness measurements (LSM) and brief alcohol intervention.",[18],"Behavioral: Elastography-based brief alcohol intervention",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"BEHAVIORAL","Participants randomized to elastography-based BAI will receive elastography assessment during first hospitalization. Elastography is a widely validated ultrasound-based technique that measures liver stiffness as a surrogate marker of liver fibrosis. The BAI will be delivered according to the FRAMES model, a structured, evidence-based framework for brief motivational interventions targeting harmful alcohol use. The intervention is patient-centered, non-confrontational, and based on principles of motivational interviewing. Both the elastography and the BAI will last approximately 10-15 minutes and will be delivered by trained study personnel directly following elastography assessment. At 3 months, participants will receive BAI by telephone. Follow-up reinforcement of elastography-based BAI will subsequently be provided during scheduled visits at 6 and 12 months.",[14],[25,29],{"name":26,"affiliation":27,"role":28},"Mette Vesterhus","Haraldsplass Deaconess Hospital, Bergen, Norway","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":32},"Håvard Midgard","Oslo University Hospital, Oslo, Norway","STUDY_CHAIR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":12,"email":38},"Håvard Midgard, Professor","CONTACT","+47 908 30 071","havardmi@gmail.com",{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},"Caroline Rootwelt","+47 928 37 796","carroo@ous-hf.no",[44,59,71,83,95,102,114,123],{"facility":45,"status":12,"city":46,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Haraldsplass Deaconess Hospital","Bergen","Norway","NO",{"type":50,"coordinates":51},"Point",[52,53],5.32415,60.39299,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":12,"phoneExt":12,"email":58},"Mette N Vesterhus","mette.vesterhus@uib.no",{"facility":60,"status":12,"city":61,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Vestre Viken Bærum Hospital","Drammen",{"type":50,"coordinates":63},[64,65],10.20449,59.74389,{"lat":65,"lon":64},[68],{"name":69,"role":36,"phone":12,"phoneExt":12,"email":70},"Annette J Ingram","annette.julia.ingram@vestreviken.no",{"facility":72,"status":12,"city":73,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Sykehuset Nord-Trøndelag Levanger","Levanger",{"type":50,"coordinates":75},[76,77],11.29963,63.74644,{"lat":77,"lon":76},[80],{"name":81,"role":36,"phone":12,"phoneExt":12,"email":82},"Eivind Ness-Jensen","eivind.ness-jensen@ntnu.no",{"facility":84,"status":12,"city":85,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Sykehuset Innlandet Lillehammer","Lillehammer",{"type":50,"coordinates":87},[88,89],10.46628,61.11514,{"lat":89,"lon":88},[92],{"name":93,"role":36,"phone":12,"phoneExt":12,"email":94},"Gunnbjørg Hjeltnes","gunnbjorg.hjeltnes@sykehuset-innlandet.no",{"facility":96,"status":12,"city":97,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":12,"geoPoint":12,"contacts":98},"Akershus University Hospital","Lørenskog",[99],{"name":100,"role":36,"phone":12,"phoneExt":12,"email":101},"Kristin K Jørgensen","Kristin.kaasen.jorgensen@outlook.com",{"facility":103,"status":12,"city":104,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Diakonhjemmet Hospital","Oslo",{"type":50,"coordinates":106},[107,108],10.74609,59.91273,{"lat":108,"lon":107},[111],{"name":112,"role":36,"phone":12,"phoneExt":12,"email":113},"Raziye Boyar","raziye.boyar@diakonsyk.no",{"facility":115,"status":12,"city":104,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},"Lovisenberg Diaconal Hospital",{"type":50,"coordinates":117},[107,108],{"lat":108,"lon":107},[120],{"name":121,"role":36,"phone":12,"phoneExt":12,"email":122},"Guro Tengesdal","guro.tengesdal@lds.no",{"facility":5,"status":12,"city":104,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},{"type":50,"coordinates":125},[107,108],{"lat":108,"lon":107},[128],{"name":129,"role":36,"phone":37,"phoneExt":12,"email":38},"Midgard Håvard, Professor",{"type":28,"investigatorFullName":30,"investigatorTitle":131,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Professor and Senior Consultant","100643589","elastography-based-brief-alcohol-intervention-in-hospitalized-individuals-100643589",false,"NCT07637539","Elastography-based Brief Alcohol Intervention in Hospitalized Individuals","Proactive Liver Disease Assessment and Brief Intervention Among Hospitalized People With Harmful Alcohol Consumption: An Investigator-initiated, Pragmatic, Parallel-group, Open-label, 2-arm Randomized Controlled Trial to Investigate the Efficacy of Proactive Elastography-based Brief Alcohol Intervention Compared With Usual Care in Hospitalized Adult Participants at Risk of Alcohol-related Liver Disease","PREDILECTION","Inclusion Criteria:\n\n1. Emergency hospitalized for any reason in any participating centre\n2. Adults 18 years or older\n3. Harmful alcohol use, defined as AUDIT-C ≥6 (for men) or AUDIT-C ≥5 (for women)\n4. Moderate to high risk of liver fibrosis, defined as FIB-4 \\>1.3\n5. Signed informed consent\n\nExclusion Criteria:\n\n1. Decompensated liver disease that impedes intervention delivery, defined as one or more of the following:\n\n   1. Moderate or severe ascites\n   2. Overt hepatic encephalopathy (West Haven grade ≥2)\n   3. Acute-on-chronic liver failure requiring admission to intensive care unit\n2. Acute hepatitis of any aetiology, defined as ALT or AST \\>5 x upper limit of normal (ULN)\n3. Unable to participate for any reason in the opinion of the investigator","ALL","18 Years",{"count":143,"type":144},500,"ESTIMATED","INTERVENTIONAL",[147],"NA","Harmful alcohol use is a common cause of hospital admissions and the leading cause of liver cirrhosis. Timely detection of liver disease is crucial to prevent liver disease progression and reduce alcohol-related harms. The hypothesis is that proactive assessment of liver health during hospitalization may motivate reductions in alcohol use and thereby prevent disease complications and recurrent admissions more effectively than usual care. The study will recruit 500 patients at risk of alcohol-related liver disease who are admitted for inpatient care for any reason. Recruitment will be done at 8 Norwegian hospitals over an 18-month period. Participants will be randomized to liver elastography (liver stiffness measurement) and personalized alcohol counselling, or to usual care. After discharge, participants will be followed with study visits after 3, 6 and 12 months. Assessments during follow-up include self-reported alcohol use, the alcohol biomarker PEth and health-related quality of life. The primary outcome is the number of emergency hospital admissions for any reason within 2 years, collected from the Norwegian Patient Registry. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking.",[150,151],"Alcoholic Liver Disease (ALD)","Alcohol Use Disorder",[153,154,155,156,157,158,159,160,161,162],"alcohol","brief intervention","brief alcohol intervention","elastography","liver fibrosis","alcohol use disorder","alcoholic liver disease","ALD","BAI","proactive liver disease assessment","NOT_YET_RECRUITING","2026-06-04",{"date":166,"type":167},"2026-06-09","ACTUAL",{"date":169,"type":144},"2026-08-15",{"date":171,"type":144},"2038-05-15",{"name":5,"class":6},8]