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Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: The NISMA Trial

RecruitingNAAges 18 Years - 120 YearsAllGlostrup University Hospital, Copenhagen
NCT06533423 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: In patients newly diagnosed with inflammatory arthritis, a self-management intervention is anticipated to enhance self-management skills, thereby improving patient function, well-being, and survival. The primary objective of the trial is to investigate the short-term efficacy of the NISMA intervention and usual care, compared to usual care alone (control group), on self-management skills and techniques in patients newly diagnosed with inflammatory arthritis. Method: This study aims to test the efficacy of the "Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention" (NISMA) through a multicenter pragmatic randomized controlled trial (RCT). The trial will involve 130 patients newly diagnosed with IA from three Danish hospitals. Participants will be randomly assigned to either the NISMA intervention group or a control group receiving usual care. The NISM

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📋 Eligibility rules (as published)
Inclusion Criteria: Patients will be included if they are adults aged 18 years or older with one of the following conditions: * Rheumatoid Arthritis (RA) with ICD-10 codes: M05.3, M05.9, M05.8, M06.9 diagnosed within the last 6 months * Psoriatic Arthritis (PsA) with ICD-10 codes: M073.A, M073.B diagnosed within the last 6 months * Axial Spondyloarthritis (axSpA) with ICD-10 codes: M45.9, M46.1, M46.8, M46.9, diagnosed within the last 12 months, and has initiated biological treatment Patients with axSpA will have unique inclusion criteria due to NSAIDs being the first-line pharmacological treatment. For those effectively treated with NSAIDs and exercise, treatment is transitioned to their general practitioner. Therefore, only those who have initiated biological treatment will be included. Exclusion Criteria: Patients will be excluded if they: * have insufficient language skills to discuss the topics in the intervention in Danish * are receiving chemo-therapy treatment for malignancies * are pregnant * have severe mental illness.
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What it tests

  • Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention (NISMA)
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Where

2 sites
Rigshospitalet, Center for Rheummatology and Spine Diseases
Glostrup Municipality, Denmark
Holbæk sygehus
Holbæk, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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