[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572152":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":124,"collaborators":24,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":24,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":24,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":150,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group (IG)","EXPERIMENTAL","Participants are randomized in an intervention group (IG) and a waiting list control group (WLG). The IG receive the intervention with Education \\& Care in RARE (all children) and complete the identical questionnaires (all children and their legal guardians) immedeately after inclusion.",[13],"Other: Education & Care in RARE",{"label":15,"type":16,"description":17,"interventionNames":18},"Waiting List Control Group (WLG)","ACTIVE_COMPARATOR","Compared to the IG, the WLG receives the intervention with Education \\& Care in RARE with a time delay (8-12 weeks later) and has one additional appointment for questionnaire evaluation before start of the intervention.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Education & Care in RARE","Education \\& Care in RARE (https:\u002F\u002Fwww.youtube.com\u002Fwatch?v=R3fr-q-6JIw) is a short-term, structured, resource-oriented and child-friendly psychoeducation program for children and adolescents with rare diseases. It promotes knowledge and competence on rare diseases in children in order to reduce the psychosocial rare disease burden and to improve individual self-competence in managing the rare disease and to improve their quality of life. Education \\& Care in RARE can be used for all pediatric rare diseases. This has the great advantage that users only need to be trained in the use of one program.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Julia Vodopiutz, MD apProf","CONTACT","+4314040032320","julia.vodopiutz@meduniwien.ac.at",[32,50,64,77,91,105,116],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":36,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Medical University of Graz","RECRUITING","Graz","Austria","8010","AT",{"type":40,"coordinates":41},"Point",[42,43],15.44197,47.06733,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":24,"email":49},"Anna Baghdasaryan, MD PhD","+43-316-385-30014","a.baghdasaryan@medunigraz.at",{"facility":51,"status":34,"city":52,"state":36,"zip":53,"country":36,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Medical University of Innsbruck","Innsbruck","6020",{"type":40,"coordinates":55},[56,57],11.39454,47.26266,{"lat":57,"lon":56},[60],{"name":61,"role":28,"phone":62,"phoneExt":24,"email":63},"Thomas Zöggeler, MD","+43 50 504 271 44","thomas.zoeggeler@tirol-kliniken.at",{"facility":65,"status":34,"city":66,"state":36,"zip":67,"country":36,"countryCode":38,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"The Faculty of Medicine JKU Linz","Linz","4020",{"type":40,"coordinates":69},[70,71],14.28611,48.30639,{"lat":71,"lon":70},[74],{"name":75,"role":28,"phone":24,"phoneExt":24,"email":76},"Magdalena Plunger, Dr","Magdalena.Plunger@kepleruniklinikum.at",{"facility":78,"status":34,"city":79,"state":36,"zip":80,"country":36,"countryCode":38,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"SALK PMU","Salzburg","5020",{"type":40,"coordinates":82},[83,84],13.04399,47.79941,{"lat":84,"lon":83},[87],{"name":88,"role":28,"phone":89,"phoneExt":24,"email":90},"Anna Spitzinger, Mag.","+435725554518","a.spitzinger@salk.at",{"facility":92,"status":34,"city":93,"state":36,"zip":94,"country":36,"countryCode":38,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"WIGEV Klinikum Favoriten","Vienna","1100",{"type":40,"coordinates":96},[97,98],16.37208,48.20849,{"lat":98,"lon":97},[101],{"name":102,"role":28,"phone":103,"phoneExt":24,"email":104},"Simone Mahal, MD","+43 1 60191 2608","simone.mahal@gesundheitsverbund.at",{"facility":106,"status":34,"city":66,"state":24,"zip":107,"country":36,"countryCode":38,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},"Ordensklinikum Linz","4010",{"type":40,"coordinates":109},[70,71],{"lat":71,"lon":70},[112],{"name":113,"role":28,"phone":114,"phoneExt":24,"email":115},"Veronika Pilshofer, MD","+4373276777211","veronika.pilshofer@ordensklinikum.at",{"facility":5,"status":34,"city":93,"state":24,"zip":117,"country":36,"countryCode":38,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"1090",{"type":40,"coordinates":119},[97,98],{"lat":98,"lon":97},[122],{"name":123,"role":28,"phone":29,"phoneExt":24,"email":30},"Julia Vodopiutz, MD",{"type":125,"investigatorFullName":126,"investigatorTitle":127,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Julia Vodopiutz","MD ap Prof","100572152","education--care-in-rare-efficacy-of-targeted-psychoeducational-intervention-among-pediatric-rare-disease-patients-100572152",false,"NCT06729554","Education & Care in RARE: Efficacy of Targeted Psychoeducational Intervention Among Pediatric Rare Disease Patients","Education & Care in RARE - Efficacy of Targeted Psychoeducational Intervention to Improve Knowledge About Rare Diseases and to Promote Mental Health Among Pediatric Rare Disease Patients","Inclusion Criteria:\n\n* Children and adolescents with a confirmed diagnosis of a rare disease with\n* Age 5-20 years, corresponding to a developmental age of 5-18 years\n* Existing medical care at a participating study center because of the rare disease\n* Voluntary participation and informed consent\n* Ability to complete the questionnaires\n* Ability to actively participate the intervention (psychoeducation)\n\nExclusion Criteria:\n\n* Moderate or severe cognitive impairment\n* Simultaneous admission of the child \u002F adolescent to a setting with high-frequency psychotherapeutic intervention (e.g. admission to psychosomatic medicine, child and adolescent psychiatry)\n* No informed consent\n* Language barrier of the child \u002F adolescent\n* Assumption that compliance is too low to attend all study appointments","ALL","5 Years","20 Years",{"count":139,"type":140},100,"ESTIMATED","INTERVENTIONAL",[143],"NA","\"Rare Diseases\" is an umbrella term including more than 8.000 different diseases which individually affect only a small percentage of people. Rare diseases predominantly affect children and adolescents and are associated with high medical and psychosocial burden of disease.\n\nThe investigators invented Education \\& Care in RARE - a short-term, structured, resource-oriented and child-friendly psychoeducation program for children and adolescents with rare diseases.\n\nThis study is a prospective, multicenter, randomized and controlled study with a waiting list. Aim of the study is to investigate the efficacy of Education \\& Care in RARE on knowledge about rare diseases and on mental health well-being in pediatric rare disease patients, compared to a control group.\n\nIn this study participants are randomized in an intervention group and a waiting list control group. Both study groups thus receive the psychoeducation with Education \\& Care in RARE and complete the identical questionnaires. Compared to the Intervention group, the waiting list control group receives the intervention with a time delay (8-12 weeks later) and has one additional appointment for questionnaire evaluation before start of the psychoeducation.",[146,147,148,149],"Orphan Diseases","Rare Disorders","Pediatric Diseases","Inborn Errors of Metabolism Disorders",[151,152,153,154,155,156,157,158],"Rare diseases","ultra-rare diseases","psychoeducation in pediatrics","psychoeducation for alle rare diseases","rare pediatric diseases","orphan diseases psychoeducation","rare disease burden","waiting list control study","2025-05-12",{"date":161,"type":162},"2025-05-13","ACTUAL",{"date":164,"type":162},"2024-12-15",{"date":166,"type":140},"2027-12-01",{"name":5,"class":6},7]