[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Danish Center for Expertise in Rheumatology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100567304","comfi---a-combined-fatigue-intervention-100567304",false,"NCT06666452","COMFI - a COMbined Fatigue Intervention","The Feasibility Test of a COMbined Fatigue Intervention (COMFI) for People With Inflammatory Athritis","COMFI","Inclusion Criteria:\n\n1. Current fatigue level (VAS-Fatigue: The VAS-fatigue has to be 60 or above.\n2. Must have experienced fatigue as a challenge for at least the last 3 months\n3. A rheumatologist-confirmed diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Spondyloarthritis\n4. The patient is in a stable phase regarding disease activity. This means no current plans to adjust pharmacological treatment, and no changes in treatment in the last 3 months (DMARDs or steroids) incl. steroid injections.\n5. Must be affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund.\n6. Age ≥18 years.\n7. Must be able to speak and write Danish or Swedish well enough to participate in group discussions without an interpreter.\n8. The participant must be interested in actively participating and making changes to daily life to improve their condition.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding\n2. Critical\u002Fserious illness:\n\n   * Diseases with an expected survival of \\\u003C 2 years (e.g., cancer)\n   * Heart failure with NYHA class 3 or 4\n   * Kidney failure with eGFR \\\u003C 30\n   * Severe anemia - hemoglobin ≤ 5.0 mmol\u002FL\n3. Clarification of known diseases, which must be well-treated or in remission:\n\n   * Diabetes: HbA1c \\>53 mmol\u002Fmol is excluded if dysregulated\n   * Thyroid disease: TSH: 0.4-4.0 mE\u002FL. Excluded if dysregulated\n4. A medical condition that would make the proposed interventions unsuitable\u002Fimpossible for group participation or hinder the ability to give informed consent:\n\n   * Unstable psychiatric illness\n   * Dementia or other severe cognitive problems\n   * Hearing loss\u002Fuse of hearing aids (it must be clarified how the person feels about being in a group setting)\n   * Other physical or mental conditions with the above effect\n5. Conditions that may be the primary cause of fatigue:\n\n   * Long-term effects after COVID-19\n   * Chronic fatigue syndrome\n6. Participation in another research project that could affect fatigue (WORK-ON, INSELMA, SPINCODE)\n7. Participation in the fatigue program for hospitalized patients or support in another way specifically related to fatigue\n8. The participant must not have a planned rehabilitation stay (e.g., Danish Rheumatism Hospital, Sano, Montebello) or another program elsewhere that works with fatigue\n9. If the participant cannot commit to attending on the scheduled dates in one of the two programs.","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","Background: Inflammatory arthritis (IA) encompasses autoimmune rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Fatigue is highly prevalent in people with IA with 41-57% suffering from severe fatigue. Patients describe fatigue as overwhelming, unpredictable, challenging to manage, and affecting all areas of everyday life, including the ability to work. Studies have shown that interventions with physical activity or a cognitive behavioral approach can significantly reduce fatigue severity and\u002For impact in people with IA compared to usual care. To date, no studies have investigated the combined effect of CBA and PA on fatigue severity and impact in patients with IA. Therefore, the goal of this study is to test the feasibility of a newly developed fatigue intervention that combines a cognitive behavioral approach and physical activity (COMFI) in patients with inflammatory arthritis, who experience fatigue as a challenge in their everyday lives in Denmark and Sweden. The intervention will be tested in 4 groups (2 in Denmark and 2 in Sweden), and the participants will participate in 7 group sessions and 2 focusgroups interview in the evaluation.\n\nThe primary outcome for the participants is fatigue, measured through patient-reported outcomes at baseline, 3, 6, and 12 months after baseline.\n\nThis study will show if the intervention is feasible in practice and meaningful for the participants.",[27,28,29,30],"Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Spondyloarthritis (SpA)","Inflammatory Arthritis",[32,33,34,35],"Fatigue","Intervention","cognitive behavioural approach","Physical activity","RECRUITING","2025-08-14",{"date":39,"type":40},"2025-08-15","ACTUAL",{"date":42,"type":40},"2024-10-01",{"date":44,"type":21},"2026-04",{"name":46,"class":47},"The Danish Center for Expertise in Rheumatology","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100560963","inselma---a-randomised-controlled-trial-100560963","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","100 Years",{"count":59,"type":21},120,[24],"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.",[63,64,65],"Rheumatoid Arthritis","Psoriatic Arthritis","Axial Spondyloarthritis",{"date":67,"type":40},"2025-08-19",{"date":69,"type":40},"2024-09-05",{"date":71,"type":21},"2027-08-31",{"name":46,"class":47},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100539136","work-on-vocational-rehabilitation-for-people-with-inflammatory-arthritis-100539136","NCT06299917","WORK-ON Vocational Rehabilitation for People with Inflammatory Arthritis","WORK-ON - Vocational Rehabilitation for People with Chronic Inflammatory Arthritis - a Randomised Controlled Trial","WORK-ON","Inclusion Criteria:\n\n* Aged 18-65 years.\n* Diagnosed with RA, PsA or axSpA by a rheumatologist.\n* Undertakes paid work (full- or part-time work or studying).\n* Able to read and understand Danish.\n* Answers 'unlikely' or 'not certain' to question #6 from the WAI questionnaire: 'Do you believe, according to your present state of health, that you will be able to do your current job two years from now?' (36).\n* Willing to participate in an RCT of the modified WORK-ON VR.\n\nExclusion Criteria:\n\n* Planned or present adjustments of the pharmacological anti-rheumatic treatment (DMARDs, glucocorticoid) within the last three months.\n* Presence of morbidities other than IA that may explain reduced work ability.\n* Is under examination for comorbidities that influence work ability.\n* Major surgery was conducted within the past six months, or a surgery has been planned.\n* Is unable to understand or speak Danish at a sufficient level to participate.\n* Has cognitive or psychological impairments that may affect participation.\n* Planned or ongoing participation in another rehabilitation program (apart from physiotherapy).\n* Has participated in the WORK-ON feasibility study.\n* Retirement application process is ongoing or plans to retire within the next five years.\n* Has taken long-term sick leave (\\>4 weeks).","65 Years",{"count":83,"type":21},56,[24],"People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues.\n\nBased on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline.",[63,64,65],"2024-10-05",{"date":89,"type":40},"2024-10-09",{"date":91,"type":40},"2024-03-01",{"date":93,"type":21},"2027-09-01",{"name":46,"class":47},1,""]