Status:

RECRUITING

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

Lead Sponsor:

Glostrup University Hospital, Copenhagen

Collaborating Sponsors:

University Hospital Bispebjerg and Frederiksberg

Aarhus University Hospital

Conditions:

Inflammatory Arthritis

Eligibility:

All Genders

18-120 years

Phase:

NA

Brief Summary

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, a...

Detailed Description

Background: Inflammatory arthritis (IA), including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA), encompasses acute and chronic joint diseases characterize...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 9 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2027

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT06533423

Start Date

December 9 2024

End Date

December 30 2027

Last Update

December 20 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Rigshospitalet, Center for Rheummatology and Spine Diseases

Glostrup Municipality, Denmark, 2600

2

Holbæk sygehus

Holbæk, Denmark, 4300