Self-management intervention for newly diagnosed inflammatory arthritis patients
Official title: Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: Study Protocol for a Randomized Controlled NISMA Trial
Run by Glostrup University Hospital, Copenhagen · NCT06533423 · Data updated 2026-11-12
This study tests a new self-management program for people recently diagnosed with inflammatory arthritis to see if it helps them feel better and manage their condition more effectively compared to regular care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | Glostrup University Hospital, Copenhagen Academic / other |
| Locations | 2 sites (Glostrup Municipality and 1 other locations) |
| Status | Recruiting |
| Started | December 9, 2024 |
| Main results expected | May 30, 2027 |
| Study ends | May 30, 2028 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT06533423 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have been newly diagnosed with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis.
✕Probably not a fit
Patients who do not speak Danish sufficiently to engage in the intervention discussions or those undergoing chemotherapy for malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the efficacy of a self-management intervention called NISMA for patients newly diagnosed with inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. The study involves a multicenter pragmatic randomized controlled trial with 130 participants from three Danish hospitals, comparing the NISMA intervention to usual care alone. The intervention includes three mandatory sessions with a nurse and aims to enhance self-management skills, improve patient function, well-being, and overall health outcomes.
Why it matters
Potential benefit: If successful, this intervention could empower patients with better self-management skills, leading to improved quality of life and health outcomes.
How similar studies have gone: Other studies have shown promise in self-management interventions for chronic conditions, suggesting potential success for this approach, although the specific NISMA intervention is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Rigshospitalet, Center for Rheummatology and Spine Diseases
Glostrup Municipality, Denmark Recruiting -
Holbæk sygehus
Holbæk, Denmark Recruiting
Study contacts
- Principal investigator: Bente A Esbensen — Rigshospitalet, Glostrup, Center for Rheumatology and Spine Diseases. COPECARE
- Study coordinator: Luise H Lindgren
- Email: luise.holberg.lindgren@regionh.dk
- Phone: 22509390
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.