Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: Study Protocol for a Randomized Controlled NISMA Trial

What this Trial Is About

Researchers are evaluating the effectiveness of a self-management intervention called NISMA for patients newly diagnosed with inflammatory arthritis (IA), including rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. The study aims to improve patients' ability to manage their symptoms, treatments, and lifestyle changes, which may enhance function, well-being, and quality of life. This pragmatic randomized controlled trial will compare the NISMA intervention plus usual care against usual care alone in patients recently diagnosed with IA. The NISMA intervention includes three mandatory individual sessions with a nurse and up to two optional group sessions over 12 months, focusing on personalized support, problem-solving, goal-setting, and techniques inspired by Acceptance and Commitment Therapy. Participants in the control group will receive usual care involving planned consultations with rheumatologists and other health professionals and the opportunity to contact a nurse as needed. The study involves 130 patients randomly assigned to either group. Participants will be assessed at the start, 12 months, and 18 months later on various outcomes such as self-management skills, quality of life, loneliness, physical function, pain levels, anxiety, depression, fatigue, disease activity, and medication adherence. Data collection includes questionnaires and clinical evaluations to monitor these effects. The trial includes safety monitoring and follows participants for up to 18 months to understand the intervention's short- and longer-term impact.

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