INSELMA - a Randomised Controlled Trial

Sponsor
The Danish Center for Expertise in Rheumatology
Study ID
NCT06583980
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 4, 2024
Start date
Sep 5, 2024
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention group
    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.
  • No Intervention: Usual care
    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.

Primary Outcome Measure

EQ5D-5L VAS [ Time Frame: Baseline, 6 and 12 months after baseline ]

Central Contacts

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