Interdisciplinary self-management support for inflammatory arthritis
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
This study is testing a new support program for people with inflammatory arthritis to see if it helps them feel better and improves their quality of life compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | The Danish Center for Expertise in Rheumatology Academic / other |
| Locations | 3 sites (Frederiksberg and 2 other locations) |
| Trial ID | NCT06583980 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a six-month nurse-coordinated interdisciplinary self-management intervention called INSELMA for patients with inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. The trial aims to compare the health-related quality of life outcomes of participants receiving the INSELMA intervention against those receiving usual care. Key secondary objectives include assessing the intervention's impact on mental well-being, anxiety, depression, and fatigue. The study builds on promising results from a pilot study involving 18 participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis for at least 24 months.
Not a fit: Patients who have recently changed their treatment regimen or are participating in other relevant studies may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and overall well-being for patients with inflammatory arthritis who struggle with substantial disease impact.
How similar studies have performed: Other studies have shown promising results with similar interdisciplinary self-management approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * 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 * 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 * report ≥60 on at least one Visual Analogue Scale (VAS) (0-100) for fatigue, pain, or global assessment of the impact of the disease Exclusion Criteria: * Planned change or a change during the past three months in treatment with disease modifying anti-rheumatic drugs (DMARDs) or glucocorticoids. * Participation in other studies of relevance for the outcomes in INSELMA (i.e. TRACE, WORK-ON, SPINCODE, COMFI, PLATE, KRAM-offer). * Not able to speak and understand Danish sufficiently to participate without a translator * Unstable psychiatric illness, cognitive impairment or other physical or mental issues that impede the ability to give informed consent to participation. * Current alcohol or drug use disorder documented in their medical journal * Pregnant or nursing a baby * Planned or ongoing rehabilitation at the Danish Hospital for Rheumatic Diseases or Sano, a pain or sleep clinic * Ongoing application for early retirement or planned surgery requiring admission * Did not participate in the INSELMA feasibility study or is a patient research partner in INSELMA
Where this trial is running
Frederiksberg and 2 other locations
- Frederiksberg Hospital — Frederiksberg, Denmark (Recruiting)
- Rigshospitalet-Glostrup — Glostrup Municipality, Denmark (Recruiting)
- Danish Hospital for Rheumatic Diseases — Sønderborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Jette Primdahl, PhD — University of Southern Denmark
- Study coordinator: Jette Primdahl, PhD
- Email: jprimdahl@danskgigthospital.dk
- Phone: 0045 2420 6692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.