INSELMA - a Randomised Controlled Trial

NCT06583980 | Recruiting

• 1 other identifier: INSELMA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• EQ5D-5L VAS

  Health related quality of life 5 dimensions, 5 levels, visual analogue scale (0-100)

  Baseline, 6 and 12 months after baseline

Secondary Outcomes (11)

• WHO-5

  Baseline, 6 and 12 months after baseline

• HADS

  Baseline, 6 and 12 months after baseline

• BRAF-NRSv2

  Baseline, 6 and 12 months after baseline

• VAS pain

  Baseline, 6 and 12 months after baseline

• Pain self-efficacy

  Baseline, 6 and 12 months after baseline

Other Outcomes (3)

• HLQ subscales 3 and 6

  Baseline, 6 and 12 months after baseline

• Smoking habits

  Baseline, 6 and 12 months after baseline

• Alcohol habits

  Baseline, 6 and 12 months after baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

Each participant is assigned a coordinating rheumatology nurse. Based on an initial bio-psycho-social assessment, the nurse and the participant define up to five activities using the Patient Specific Functional Scale (PSFS) and agree on goals based on shared decision-making. The coordinating nurse provides self-management support in face-to-face, telephone or online consultations depending on the participant's needs during the following six months. At each face-to-face consultation with the nurse, the PSFS activities and the goals are evaluated. Each participant can get up to 2.5 hours of support from the nurse, up to 4 hours a physiotherapist and or occupational therapist, and 1 hour from a social worker. In addition, the coordinating nurse helps identify relevant offers in the participant's municipality. The coordinating nurse can plan up to two conferences with involved professionals. A final consultation with the coordinating nurse is held after the six-month intervention.

Behavioral: Interdisciplinary Nurse-coordinated self-management support for people with inflammatory arthritis and substantial disease impact

Usual care

NO INTERVENTION

Usual care consists of planned consultations every 6-12 months by a rheumatologist or a rheumatology nurse and access to support from a rheumatology nurse by telephone. The planned consultations encompass review of blood tests, joint examinations, review of completed answers to questionnaires in DANBIO, adherence and evaluation of whether pharmacological adjustment is necessary. In addition, the planned nursing consultations sporadically encompass education in relation to management of the disease, symptoms and the pharmacological treatment. At the outpatient departments at the Danish Hospital for Rheumatic Diseases, Rigshospitalet-Glostrup and Frederiksberg Hospital, patients who have specific challenges can be offered an additional nursing consultation for non-pharmacological support. At Rigshospitalet-Glostrup it is also possible to refer a patient to see a physiotherapist and/ or an occupational therapist in the outpatient department.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Danish Center for Expertise in Rheumatology: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (3)

Frederiksberg Hospital

Frederiksberg, 2000, Denmark

RECRUITING

Rigshospitalet-Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

Danish Hospital for Rheumatic Diseases

Sønderborg, 6400, Denmark

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Ankylosis

Study Officials

• Jette Primdahl, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jette Primdahl, PhD

CONTACT

0045 2420 6692; jprimdahl@danskgigthospital.dk

Bente Appel Esbensen, PhD

CONTACT

0045 2441 2490; bente.appel.esbensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: It is not possible to blind the intervention to the participants and the healthcare professionals in this trial. To ensure blinding in the analyses, all patient participants will be given a number for reference and the person performing the statistical analyses will be blinded to allocation group. A research nurse will inform the participants about group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in rheumatology rehabilitation

Model Details: Experimental group and control group (usual care)

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: September 4, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

DK (3)