INSELMA - a Randomised Controlled Trial

ConditionsRheumatoid Arthritis Psoriatic Arthritis Axial Spondyloarthritis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-100

SponsorThe Danish Center for Expertise in Rheumatology

About this trial

Background:

Patients with inflammatory arthritis (IA) experience substantial impact of their disease despite optimal pharmacological treatment. To be able to manage these challenges effectively, patients require tailored self-management support from various professionals. We thus developed a six-month nurse-coordinated interdisciplinary self-management intervention (INSELMA), in collaboration with patients, clinicians and managers. A pilot study on the INSELMA intervention in 18 participants showed promising results. It is now relevant to test the intervention and compare it to a control group in a larger study .

Objectives:

The primary objective is to compare the efficacy of the INSELMA intervention to usual care (control group), on health related quality of life measured at baseline and end of intervention (6 months after baseline).

Key secondary objectives are to compare the short and longer-term effect of INSELMA on changes in mental well-being, anxiety, depression, fatigue, pain, sleep, physical activity, global impact of the disease, work ability, self-efficacy for managing chronic disease and pain and health literacy relative to usual care from baseline to 6 and 12 months after baseline and on quality of life from baseline to 12 months after baseline.

Method:

A pragmatic randomised trial with a two-group parallel design.

All participants will be randomly allocated to the intervention or usual care only .

Both groups will receive usual care. The INSELMA intervention group will be assigned a coordinating rheumatology nurse who performs an initial biopsychosocial assessment. Based on the assessment, the nurse and the patient agree on which activities and goals to work towards for the following six months. The coordinating nurse can refer the patient to see a physiotherapist, an occupational therapist or social worker if needed and can help identify offers in the patients' municipality.

The primary endpoint will be change in quality of life from baseline to 6 month after baseline. Key secondary outcome measures are collected to compare the effect of INSELMA on changes in mental well-being, anxiety, depression, fatigue, pain, self-efficacy for managing pain, physical function, global impact of the disease, sleep problems and acceptable symptoms relative to usual care from baseline to 6 and 12 months after baseline.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Interdisciplinary Nurse-coordinated self-management support for people with inflammatory arthritis and substantial disease impact
Behavioral
A coordinating rheumatology nurse who follows the participant for six months, goal setting and action planning with the nurse, opportunity for needs based support from a physiotherapist, an occupational therapist and a social worker, opportunity for interdisciplinary conferences to coordinate support to achieve the agreed upon goals and a final status consultation.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Intervention groupExperimental treatment 1 intervention

Group B: Usual careNo intervention 0 interventions

Trial outcomes