A personal nurse and a plan: could this ease the daily burden of arthritis?

NCT ID NCT06583980

Symptom relief Sponsor: The Danish Center for Expertise in Rheumatology Source: ClinicalTrials.gov ↗

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests a six-month program where a coordinating rheumatology nurse helps people with inflammatory arthritis set goals and plan actions to manage their condition. Participants also get access to physiotherapy, occupational therapy, and social work support as needed. The study compares this program to usual care alone, measuring changes in quality of life, mental well-being, fatigue, pain, and sleep. The goal is to see if this extra support helps people who still feel a substantial impact from their disease despite standard treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: A six-month nurse-coordinated self-management program that includes goal setting, action planning, and access to physiotherapy, occupational therapy, and social work support.
What this could lead to: If it works, this program could become a standard way to help people with inflammatory arthritis feel better and manage daily life, beyond just medication.
What could go wrong: This is a mid-sized trial, and the program may not improve quality of life more than usual care. Results depend on how well participants engage with the support.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Axial Spondyloarthritis psoriatic arthritis rheumatoid arthritis spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Axial spondyloarthritis Psoriatic arthritis Rheumatoid arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

A personal nurse and a plan: could this ease the daily burden of arthritis?

What the study statuses mean