[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560963":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":92,"collaborators":95,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":18,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":18,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"The Danish Center for Expertise in Rheumatology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Each participant is assigned a coordinating rheumatology nurse. Based on an initial bio-psycho-social assessment, the nurse and the participant define up to five activities using the Patient Specific Functional Scale (PSFS) and agree on goals based on shared decision-making. The coordinating nurse provides self-management support in face-to-face, telephone or online consultations depending on the participant's needs during the following six months. At each face-to-face consultation with the nurse, the PSFS activities and the goals are evaluated. Each participant can get up to 2.5 hours of support from the nurse, up to 4 hours a physiotherapist and or occupational therapist, and 1 hour from a social worker. In addition, the coordinating nurse helps identify relevant offers in the participant's municipality. The coordinating nurse can plan up to two conferences with involved professionals. A final consultation with the coordinating nurse is held after the six-month intervention.",[13],"Behavioral: Interdisciplinary Nurse-coordinated self-management support for people with inflammatory arthritis and substantial disease impact",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","NO_INTERVENTION","Usual care consists of planned consultations every 6-12 months by a rheumatologist or a rheumatology nurse and access to support from a rheumatology nurse by telephone. The planned consultations encompass review of blood tests, joint examinations, review of completed answers to questionnaires in DANBIO, adherence and evaluation of whether pharmacological adjustment is necessary. In addition, the planned nursing consultations sporadically encompass education in relation to management of the disease, symptoms and the pharmacological treatment. At the outpatient departments at the Danish Hospital for Rheumatic Diseases, Rigshospitalet-Glostrup and Frederiksberg Hospital, patients who have specific challenges can be offered an additional nursing consultation for non-pharmacological support. At Rigshospitalet-Glostrup it is also possible to refer a patient to see a physiotherapist and\u002F or an occupational therapist in the outpatient department.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Interdisciplinary Nurse-coordinated self-management support for people with inflammatory arthritis and substantial disease impact","A coordinating rheumatology nurse who follows the participant for six months, goal setting and action planning with the nurse, opportunity for needs based support from a physiotherapist, an occupational therapist and a social worker, opportunity for interdisciplinary conferences to coordinate support to achieve the agreed upon goals and a final status consultation.",[9],[26],{"name":27,"affiliation":28,"role":29},"Jette Primdahl, PhD","University of Southern Denmark","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","0045 2420 6692","jprimdahl@danskgigthospital.dk",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Bente Appel Esbensen, PhD","0045 2441 2490","bente.appel.esbensen@regionh.dk",[40,62,75],{"facility":41,"status":42,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Frederiksberg Hospital","RECRUITING","Frederiksberg","2000","Denmark","DK",{"type":48,"coordinates":49},"Point",[50,51],12.53463,55.67938,{"lat":51,"lon":50},[54,56,60],{"name":55,"role":32,"phone":37,"phoneExt":18,"email":38},"Bente A Esbensen, PhD",{"name":57,"role":32,"phone":58,"phoneExt":18,"email":59},"Luise H Lindgren, PhD","0045 2153 9722","luise.holberg.lindgren@regionh.dk",{"name":55,"role":61,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"facility":63,"status":42,"city":64,"state":18,"zip":65,"country":45,"countryCode":46,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Rigshospitalet-Glostrup","Glostrup Municipality","2600",{"type":48,"coordinates":67},[68,69],12.40377,55.6666,{"lat":69,"lon":68},[72,73,74],{"name":55,"role":32,"phone":37,"phoneExt":18,"email":38},{"name":57,"role":32,"phone":18,"phoneExt":58,"email":59},{"name":55,"role":61,"phone":18,"phoneExt":18,"email":18},{"facility":76,"status":42,"city":77,"state":18,"zip":78,"country":45,"countryCode":46,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Danish Hospital for Rheumatic Diseases","Sønderborg","6400",{"type":48,"coordinates":80},[81,82],9.78917,54.90896,{"lat":82,"lon":81},[85,87,91],{"name":27,"role":32,"phone":86,"phoneExt":18,"email":34},"004524206692",{"name":88,"role":32,"phone":89,"phoneExt":18,"email":90},"Berit F Petersen, MPQM","004573654041","bpetersen@danskgigthospital.dk",{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"type":29,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Jette Primdahl","Professor in rheumatology rehabilitation",[96],{"name":97,"class":6},"Rigshospitalet, Denmark","100560963","inselma---a-randomised-controlled-trial-100560963",false,"NCT06583980","INSELMA - a Randomised Controlled Trial","The Efficacy of a Complex Interdisciplinary Nurse-Coordinated SELf-MAnagement Intervention for People With Substantial Impact From Their Inflammatory Arthritis: Protocol for the Randomized Pragmatic INSELMA Trial","INSELMA-RCT","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Diagnosed with RA, PsA, or axSpA by a rheumatologist for at least 24 months. Connected to the rheumatology department of one of the participating hospitals for at least two years\n* Answer \"no\" to the Patient Acceptable Symptom State (PASS) (36), \"Think about all the ways your arthritis has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable to you?\" or\n* report ≥60 on at least one Visual Analogue Scale (VAS) (0-100) for fatigue, pain, or global assessment of the impact of the disease\n\nExclusion Criteria:\n\n* Planned change or a change during the past three months in treatment with disease modifying anti-rheumatic drugs (DMARDs) or glucocorticoids.\n* Participation in other studies of relevance for the outcomes in INSELMA (i.e. TRACE, WORK-ON, SPINCODE, COMFI, PLATE, KRAM-offer).\n* Not able to speak and understand Danish sufficiently to participate without a translator\n* Unstable psychiatric illness, cognitive impairment or other physical or mental issues that impede the ability to give informed consent to participation.\n* Current alcohol or drug use disorder documented in their medical journal\n* Pregnant or nursing a baby\n* Planned or ongoing rehabilitation at the Danish Hospital for Rheumatic Diseases or Sano, a pain or sleep clinic\n* Ongoing application for early retirement or planned surgery requiring admission\n* Did not participate in the INSELMA feasibility study or is a patient research partner in INSELMA","ALL","18 Years","100 Years",{"count":110,"type":111},120,"ESTIMATED","INTERVENTIONAL",[114],"NA","Background:\n\nPatients with inflammatory arthritis (IA) experience substantial impact of their disease despite optimal pharmacological treatment. To be able to manage these challenges effectively, patients require tailored self-management support from various professionals. We thus developed a six-month nurse-coordinated interdisciplinary self-management intervention (INSELMA), in collaboration with patients, clinicians and managers. A pilot study on the INSELMA intervention in 18 participants showed promising results. It is now relevant to test the intervention and compare it to a control group in a larger study .\n\nObjectives:\n\nThe primary objective is to compare the efficacy of the INSELMA intervention to usual care (control group), on health related quality of life measured at baseline and end of intervention (6 months after baseline).\n\nKey secondary objectives are to compare the short and longer-term effect of INSELMA on changes in mental well-being, anxiety, depression, fatigue, pain, sleep, physical activity, global impact of the disease, work ability, self-efficacy for managing chronic disease and pain and health literacy relative to usual care from baseline to 6 and 12 months after baseline and on quality of life from baseline to 12 months after baseline.\n\nMethod:\n\nA pragmatic randomised trial with a two-group parallel design.\n\nAll participants will be randomly allocated to the intervention or usual care only .\n\nBoth groups will receive usual care. The INSELMA intervention group will be assigned a coordinating rheumatology nurse who performs an initial biopsychosocial assessment. Based on the assessment, the nurse and the patient agree on which activities and goals to work towards for the following six months. The coordinating nurse can refer the patient to see a physiotherapist, an occupational therapist or social worker if needed and can help identify offers in the patients' municipality.\n\nThe primary endpoint will be change in quality of life from baseline to 6 month after baseline. Key secondary outcome measures are collected to compare the effect of INSELMA on changes in mental well-being, anxiety, depression, fatigue, pain, self-efficacy for managing pain, physical function, global impact of the disease, sleep problems and acceptable symptoms relative to usual care from baseline to 6 and 12 months after baseline.",[117,118,119],"Rheumatoid Arthritis","Psoriatic Arthritis","Axial Spondyloarthritis","2025-08-14",{"date":122,"type":123},"2025-08-19","ACTUAL",{"date":125,"type":123},"2024-09-05",{"date":127,"type":111},"2027-08-31",{"name":5,"class":6},3]