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Search / Trial NCT06533423

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

Launched by GLOSTRUP UNIVERSITY HOSPITAL, COPENHAGEN · Jul 29, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Self Management Rheumatoid Arthritis Axial Spondyloarthritis Psoriatic Arthritis Newly Diagnosed Hei Q Quality Of Life

ClinConnect Summary

The NISMA trial is studying a special program designed to help people who have recently been diagnosed with inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis. The program aims to teach patients important self-management skills to improve their daily functioning and overall well-being. In this study, 130 participants will be randomly assigned to either receive the NISMA program, which includes meetings with a nurse and optional group sessions, or to a control group that only receives standard care. Researchers will track how well these patients manage their condition over 12 to 18 months by looking at various factors, including their quality of life, pain levels, and mental health.

To be eligible for this trial, participants must be adults aged 18 and older who have been diagnosed with one of the specified types of inflammatory arthritis within the last six to twelve months. Certain individuals, such as those with severe mental illness or who are pregnant, will not be included. This trial is important because it could lead to better ways to help newly diagnosed patients manage their arthritis and improve their quality of life, addressing both physical and emotional challenges.

Gender

ALL

Eligibility 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.

About Glostrup University Hospital, Copenhagen

Glostrup University Hospital, located in Copenhagen, is a leading clinical research institution renowned for its commitment to advancing medical science and patient care through innovative clinical trials. As a part of the Copenhagen University Hospital network, it integrates cutting-edge research with comprehensive healthcare services, focusing on a wide range of medical disciplines. The hospital fosters collaborative partnerships with academic institutions and industry stakeholders to facilitate the development of new therapies and interventions, ensuring rigorous adherence to ethical standards and regulatory guidelines. With a dedicated team of experienced clinicians and researchers, Glostrup University Hospital is at the forefront of translating research findings into practical treatments that enhance patient outcomes.

Locations

Holbæk, , Denmark

Glostrup, Region Hovedstaden, Denmark

Glostrup, , Denmark

Patients applied

0 patients applied

Trial Officials

Bente A Esbensen

Principal Investigator

Rigshospitalet, Glostrup, Center for Rheumatology and Spine Diseases. COPECARE

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported