[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486449":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":69,"collaborators":18,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":18,"enrollmentInfo":82,"targetDuration":18,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Biochemistry interpretive comment on LDL-C levels","EXPERIMENTAL","The general practitioners and hospital wards will be allocated in cluster according to their providing lab, and stepwise implement the comment on LDL-C ≥ 4 mmol\u002FL in persons under the age of 40 and ≥ 5 mmol\u002FL in persons ≥ 40 years. Raising awareness on familial hypercholesterolemia an encouraging to referral.\n\nCluster 1. Will from the 01.12.2022 implement comment on LDL-C Cluster 2. Will from the 01.03.2023 implement comment on LDL-C Cluster 3. Will from the 01.06.2023 implement comment on LDL-C Cluster 4.Will from the 01.09.2023 implement comment on LDL-C",[13],"Other: Biochemistry interpretive comment on elevated LDL-C levels",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","The clusters will act as their own controls, due to the stepwise implementation of the comment.\n\nCluster 2: Will not implement the comment before the 01.03.2023 Cluster 3: Will not implement the comment before the 01.06.2023 Cluster 4: Will not implement the comment before the 01.09.2023",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Biochemistry interpretive comment on elevated LDL-C levels","The interpretive comment on LDL-C will encourage for excluding secondary dyslipidemia (measuring Hba1C, TSH and checking current drugs and talk about diet). If secondary dyslipidemia ca be excluded we encourage to referral to lipid clinic. Familial hypercholesterolemia should be suspected if LDL-C ≥ 4 mmol\u002FL in persons under the age of 40, or LDL-C ≥ 5 mmol\u002FL in persons ≥ 40. The biochemistry interpretive comment will thus be released to the referring physician if the blood sample meet the criteria above. We advice that in pregnant women to control elevated LDL-C after childbirth.",[9],[25],{"name":26,"affiliation":27,"role":28},"Finn Lund Henriksen, Ph.d.","Departement of Cardiology, Odense University Hospital","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Jakob Knold, MD","CONTACT","004541278928","jakobknold@rsyd.dk",{"name":26,"role":32,"phone":36,"phoneExt":18,"email":37},"29679722","finn.l.henriksen@rsyd.dk",[39,59],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Odense","Funen","5000","Denmark","DK",{"type":47,"coordinates":48},"Point",[49,50],10.38831,55.39594,{"lat":50,"lon":49},[53,57],{"name":54,"role":32,"phone":55,"phoneExt":18,"email":56},"Jakob Knold, M.d.","+4541278928","jakob.knold@rsyd.dk",{"name":58,"role":32,"phone":18,"phoneExt":18,"email":18},"Knold",{"facility":27,"status":40,"city":60,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Odense C",{"type":47,"coordinates":62},[63,64],10.39538,55.40841,{"lat":64,"lon":63},[67],{"name":68,"role":32,"phone":18,"phoneExt":18,"email":18},"Finn Lund Henriksen, MD",{"type":28,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Jakob Knold","MD","100486449","familial-hypercholesterolemia-interpretive-comment---nudging-to-detection-100486449",false,"NCT05614219","Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.","Can Biochemistry Interpretive Comments on Elevated Cholesterol Levels, Increase Referrals to Lipid Clinics and Detection Rate of Familial Hypercholesterolemia? A Step Wedge Cluster Randomized Controlled Trial.","FIND","Inclusion Criteria:\n\n* All referred patients to the lipid clinics of Southern Denmark\n* LDL-C ≥ 4 mmol\u002FL in persons under the age of 40.\n* LDL-C ≥ 5 mmol\u002FL in persons ≥ 40 years.\n\nExclusion Criteria:\n\nPregnancy and Secondary dyslipidemia\n\n* Dysregulated diabetes. Hba1C \\\u003C 48\n* Dysregulated hypothyreosis. Elevated TSH.\n* Kombined hyperlipidiemia TG \\> 4 mmol\u002FL\n* Nefrotic syndrome: proteinuria \\> 3 g\u002FL and s-albumin \\\u003C 30 g\u002Fl\n* Cholestasis (alcalic fosfatase \\> 105 U\u002FL and GGT \\> 55 U\u002FL) 14 days prior to LDL-C measuring\n* Pharmacological induced hyperlipidimia","ALL","18 Years",{"count":83,"type":84},2000,"ESTIMATED","INTERVENTIONAL",[87],"NA","Familial hypercholesterolemia is the most common inherited disease of the lipid metabolism, however it remains underdiagnosed. Only 15 % of 30.000 possible patients have been found in Denmark. This quality assessing project will through a step wedge cluster randomized controlled trial evaluate establishment of a biochemistry interpretive comment on elevated LDL-C levels. The study will test if the comment results in an increase in referred patients to the lipid clinics of Southern Denmark as the primary endpoint, and as the secondary endpoint in more patients diagnosed with familial hypercholesterolemia. The project will run in totally 52 weeks and will in steps initiate the comment from the different laboratories in the Region of Southern Denmark.",[90],"Familial Hypercholesterolemia",[90,92,93,94],"Biochemistry interpretive comment","Low-density lipoprotein cholesterol levels","Screening","2026-02-18",{"date":97,"type":98},"2026-02-20","ACTUAL",{"date":100,"type":98},"2023-12-01",{"date":102,"type":84},"2027-05-01",{"name":5,"class":6},2]