INSELMA - a Randomised Controlled Trial

Launched by THE DANISH CENTER FOR EXPERTISE IN RHEUMATOLOGY · Sep 1, 2024

Keywords

ClinConnect Summary

The INSELMA trial is studying a new program designed to help people with inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, manage their condition better. This program involves working closely with a nurse who will assess each patient’s needs and help them set personal goals for the next six months. The goal is to improve patients' quality of life and address various aspects of their health, like mental well-being, pain, fatigue, and daily activities. Participants will be randomly assigned to either receive this new support program or continue with their usual care.

To join the study, participants need to be adults aged 18 or older who have been diagnosed with one of the specified types of arthritis for at least two years. They should be connected to a rheumatology department and need to show that their symptoms have a significant impact on their daily lives. Throughout the trial, participants can expect regular check-ins with the nurse and support from other healthcare professionals as needed. This study is currently recruiting participants, and it aims to provide valuable insights into how tailored self-management can enhance the lives of those living with inflammatory arthritis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 18 years or older
• • Diagnosed with RA, PsA, or axSpA by a rheumatologist for at least 24 months. Connected to the rheumatology department of one of the participating hospitals for at least two years
• • Answer "no" to the Patient Acceptable Symptom State (PASS) (36), "Think about all the ways your arthritis has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable to you?" or
• • report ≥60 on at least one Visual Analogue Scale (VAS) (0-100) for fatigue, pain, or global assessment of the impact of the disease
• Exclusion Criteria:
• • Planned change or a change during the past three months in treatment with disease modifying anti-rheumatic drugs (DMARDs) or glucocorticoids.
• • Participation in other studies of relevance for the outcomes in INSELMA (i.e. TRACE, WORK-ON, SPINCODE, COMFI, PLATE, KRAM-offer).
• • Not able to speak and understand Danish sufficiently to participate without a translator
• • Unstable psychiatric illness, cognitive impairment or other physical or mental issues that impede the ability to give informed consent to participation.
• • Current alcohol or drug use disorder documented in their medical journal
• • Pregnant or nursing a baby
• • Planned or ongoing rehabilitation at the Danish Hospital for Rheumatic Diseases or Sano, a pain or sleep clinic
• • Ongoing application for early retirement or planned surgery requiring admission
• • Did not participate in the INSELMA feasibility study or is a patient research partner in INSELMA