NCT06533423 Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: The NISMA Trial
| NCT ID | NCT06533423 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Glostrup University Hospital, Copenhagen |
| Condition | Inflammatory Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2024-12-09 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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 NISMA intervention includes three mandatory individual sessions with a nurse, supplemented by two optional group sessions over 12 months. Primary outcomes will be measured using the Health Education Impact Questionnaire (heiQ), focusing on the "skill and technique acquisition" domain. Secondary outcomes include other heiQ domains, quality of life, loneliness, physical function, pain intensity, pain, self-efficacy, anxiety and depression, fatigue, patient global assessment, disease activity, and medication adherence. Data will be collected at baseline, 12 months, and 18 months post-baseline. Discussion: This RCT will provide essential insights into the effectiveness of a targeted self-management intervention for patients newly diagnosed with IA. The NISMA intervention, developed following the Medical Research Council Framework for complex interventions, aims to improve self-management skills and overall QoL. By addressing the unique challenges faced by newly diagnosed patients, this study seeks to enhance the initial management of IA, aligning with the European Alliance of Associations for Rheumatology (EULAR) recommendations for self-management support. If successful, the NISMA intervention could represent a significant advancement in the non-pharmacological management of IA, offering a comprehensive, patient-centered approach that addresses both physical and psychological needs.
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.
Contact & Investigator
Bente A Esbensen
PRINCIPAL INVESTIGATOR
Rigshospitalet, Glostrup, Center for Rheumatology and Spine Diseases. COPECARE
Frequently Asked Questions
Who can join the NCT06533423 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Inflammatory Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06533423 currently recruiting?
Yes, NCT06533423 is actively recruiting participants. Contact the research team at luise.holberg.lindgren@regionh.dk for enrollment information.
Where is the NCT06533423 trial being conducted?
This trial is being conducted at Glostrup Municipality, Denmark, Holbæk, Denmark.
Who is sponsoring the NCT06533423 clinical trial?
NCT06533423 is sponsored by Glostrup University Hospital, Copenhagen. The principal investigator is Bente A Esbensen at Rigshospitalet, Glostrup, Center for Rheumatology and Spine Diseases. COPECARE. The trial plans to enroll 130 participants.