Testing a Nurse-Led Self-Management Support Program for Adults with Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis Comparing the Six-Month INSELMA Intervention to Usual Care to Improve Quality of Life and Well-Being

What this Trial Is About

Researchers are evaluating a six-month nurse-coordinated interdisciplinary self-management support program INSELMA for adults with inflammatory arthritis IA who experience substantial disease impact despite optimal medical treatment. This trial compares the effects of the INSELMA intervention to usual care on health-related quality of life and other outcomes such as mental well-being, anxiety, depression, fatigue, pain, sleep, physical activity, and work ability. The study includes adults diagnosed with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who have significant symptoms and challenges managing their condition. Participants are randomly assigned to either the INSELMA intervention or usual care. Those in the intervention group receive personalized support from a coordinating rheumatology nurse who performs an initial biopsychosocial assessment, helps set goals, and provides up to 2.5 hours of nurse support over six months through face-to-face, phone, or online consultations. The nurse may refer participants to physiotherapists, occupational therapists, or social workers as needed and coordinate interdisciplinary meetings. The usual care group receives standard rheumatology consultations and access to nurse support as typically provided. Throughout the study, participants complete questionnaires at baseline, 6 months, and 12 months to assess quality of life, mental health, fatigue, pain, physical function, and other symptoms. Data are collected electronically or by mail. Researchers monitor safety and adverse events during the intervention. The primary outcome is health-related quality of life measured at 6 months, with additional follow-ups to evaluate longer-term effects. The total participation duration spans up to 12 months from baseline.

INSELMA - a Randomised Controlled Trial