[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552899":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":31,"studyPopulation":20,"armGroups":32,"interventions":43,"overallOfficials":20,"centralContacts":52,"locations":63,"responsibleParty":97,"collaborators":99,"id":111,"slug":20,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":20,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":66,"whyStopped":20,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Johannes Gutenberg University Mainz","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Are there differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the controll group- operationalized by the PDQ-39","Parkinson´s Disease Quetionnaire -39 - to measure the differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the control group","duration of the intervention: 24 months",[14,17],{"measure":15,"description":16,"timeFrame":12},"Are there differences in the change in motor symptoms after 12 months of observation between the intervention group and the control group measured with the MDS-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS III)","MDS-UPDRS III- to measure the differences in the change in motor symptoms after 12 months of observation between the intervention group and the control group",{"measure":18,"description":19,"timeFrame":12},"Are there differences in the change in quality of life across diseases after 12 months of observation between the intervention and the control group measured with the European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-5L)","EQ-5D-5L- to measure the differences in the change in quality of life across diseases after 12 months of observation between the intervention group and the control group",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":6,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","Study design: mixed-method approach; randomized study design. Planned intervention period: 12 months.",{"masking":26,"maskingDescription":27,"whoMasked":28},"DOUBLE","The participants are randomized into two groups: Interventional and control group. Neither APN nor the patients know in which group they belong until the first visit.",[29,30],"PARTICIPANT","CARE_PROVIDER","To effectively influence the long-term course of Parkinson´s a synergistic application of an individualized therapy program, which is tailored specifically to the symptoms and disease stages, is needed. The central element of the new form of care is the implementation of a tele medical evaluation and coordination function, which controls individualized treatment processes within the network. The individualized evaluation and coordination of treatment paths is carried out within the already existing Parkinson's network RheinMain+ by a non-physician medical specialist (APN) specially trained for the indication Parkinson's disease. In-depth assessments of the individual disease situation of the patients will take place. Based on these assessments, an evidence-based and patient-centered treatment and care plan is developed. The treatment plans are monitored, controlled and evaluated by the APNs using audiovisual or tele medical communication. In addition, APNs are empowered to initiate treatment interventions necessary to implement clinical guidelines and standards, and to take charge of these interventions as part of delegation processes. The APNs ensure that patients are cared for in accordance with needs and guidelines in all areas of care. To this end, they offer, among other things, training in the handling of patients with Parkinson's disease for other professional groups involved in the treatment process and not only have the patients in mind, but also include relatives and the supporting team.",[33,38],{"label":34,"type":6,"description":35,"interventionNames":36},"Interventional group","New intervention form",[37],"Other: New Intervention form including",{"label":39,"type":6,"description":40,"interventionNames":41},"control group.","Standard treatment for Parkinson Disease",[42],"Other: Standard treatment",[44,48],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":20},"New Intervention form including","The central element of the new form of care is the implementation of a tele medical evaluation and coordination function, which controls individualized treatment processes within the network. The individualized evaluation and coordination of treatment paths is carried out within the already existing Parkinson's network RheinMain+ by a non-physician medical specialist (APN) specially trained for the indication Parkinson's disease.",[34],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":20},"Standard treatment","The standard treatment which all compulsory insured patients get.",[39],[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Sergiu Groppa, Prof.","CONTACT","+49 613117","7838","Sergiu.Groppa@uks.eu",{"name":60,"role":55,"phone":56,"phoneExt":61,"email":62},"Franziska Beyer","7839","inspire-info@parkinsonnetzwerk.de",[64,81],{"facility":65,"status":66,"city":67,"state":20,"zip":20,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Universtity of Saarland, Campus Homburg, Dept. of Neurology","RECRUITING","Homburg","Germany","DE",{"type":71,"coordinates":72},"Point",[73,74],7.33867,49.32637,{"lat":74,"lon":73},[77],{"name":78,"role":55,"phone":79,"phoneExt":80,"email":58},"Sergiu Groppa","+49 68411624","103",{"facility":82,"status":66,"city":83,"state":20,"zip":84,"country":68,"countryCode":69,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"INSPIRE-PNRM+ Neuroimaging Center (NIC) University Medical Center of the Johannes Gutenberg University Mainz","Mainz","55131",{"type":71,"coordinates":86},[87,88],8.28008,49.98185,{"lat":88,"lon":87},[91,93,95],{"name":60,"role":55,"phone":92,"phoneExt":57,"email":62},"+49 (0) 6131 17",{"name":94,"role":55,"phone":92,"phoneExt":61,"email":62},"Selina Frühwald",{"name":78,"role":96,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":96,"investigatorFullName":78,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Univ.-Prof. Dr. med. Dr. h.c. Sergiu Groppa, MBA",[100,103,105,107,109],{"name":101,"class":102},"Hochschule für Wirtschaft und Gesellschaft Ludwigshafen Institut für Management, Ökonomie und Versorgung im Gesundheitsbereich","UNKNOWN",{"name":104,"class":102},"Katholische Hochschule Mainz Fachbereich Gesundheit und Pflege",{"name":106,"class":102},"Universitätsklinikum Frankfurt Zentrum der Neurologie und Neurochirurgie",{"name":108,"class":102},"Techniker Krankenkasse Landesvertretung Rheinland-Pfalz",{"name":110,"class":102},"DAK-Gesundheit Landesvertretung Rheinland-Pfalz und Saarland","100552899",false,"NCT06479083","Interdisciplinary + Intersectoral Telemedicine Evaluation, Coordination + Treatment in RhineMain+ Parkinson's Network","Interdisciplinary and Intersectoral Telemedicine Evaluation, Coordination and Treatment in the Rhine Main+ Parkinson's Network","INSPIRE-PNRM","Inclusion Criteria:\n\n* Diagnosis of primary Parkinson's syndrome (G20.-) or atypical Parkinson's syndrome (G23.-, according to the current diagnostic criteria of the Movement Disorder Society, including the criteria of at least bradykinesia and rigidity or resting tremor must be present)\n* In the care regions of Hesse and Rhineland-Palatinate\n* Ability to give consent present\n\nExclusion Criteria:\n\n\\- Severe dementia\n\n* Severe depression\n* Psychoses or other psychiatric or medical comorbidities that could affect the smooth implementation of the study protocol (e.g.\n\ntumor disease with limited life expectancy, need for dialysis, etc.)\n\n* Drug or alcohol addiction\n* Women who are pregnant or breastfeeding\n* Simultaneous participation in another interventional treatment study\n* Illiteracy or insufficient language skills","ALL","30 Years","85 Years",{"count":122,"type":123},1354,"ESTIMATED","INTERVENTIONAL",[126],"NA","Project objective: To improve the health care of Parkinson's disease patients in the ParkinsonNetz RheinMain+.\n\nHypothesis: Through the interdisciplinary and cross- sectoral networking in a tele medical network and the coordinating function of an \"advanced practice nurse\" (APN) specially trained for Parkinson's disease, the process quality within the network is increased and the individual health status is positively influenced.",[129],"Parkinson Disease",[131],"Parkinson Disease, Advanced Practice Nurse, Telemedical, Interdisciplinary, cross-sector care networks and pathways.","2025-07-18",{"date":134,"type":135},"2025-07-23","ACTUAL",{"date":137,"type":135},"2024-07-01",{"date":139,"type":123},"2027-01-31",{"name":5,"class":6},2]