INSELMA - a Randomised Controlled Trial
NCT Number: NCT06583980
Acronym: INSELMA-RCT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rheumatoid Arthritis|Psoriatic Arthritis|Axial Spondyloarthritis
Sponsor: The Danish Center for Expertise in Rheumatology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-02
Completion Date: 2026-08-31

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.

Primary Outcome Measures: 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 Outcome Measures: WHO-5, World Health Organizations 5 mental health index (0-100, lover scores reflect lower mental well-being), Baseline, 6 and 12 months after baseline|HADS, Hospital Anxiety and Depression Scale (0-21, higher scores reflect higher risk for developing anxiety and depression), Baseline, 6 and 12 months after baseline|BRAF-NRSv2, Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales version 2 for fatigue severity, impact and coping (0-100, higher scores reflect higher severity, impact and worse coping), Baseline, 6 and 12 months after baseline|VAS pain, Visual Analogue Scale Pain (0-100, higher scores reflect worse pain), Baseline, 6 and 12 months after baseline|Pain self-efficacy, Self-efficacy for managing pain (0-60, higher scores reflect higher degree of self-efficacy in managing pain), Baseline, 6 and 12 months after baseline|MD-HAQ, Multi-dimensional Health Assessment Questionnaire, (0-3, higher scores reflect higher degree of physical limitations), Baseline, 6 and 12 months after baseline (in patients with rheumatoid arthritis and psoriatic arthritis only)|BASFI, Bath Ankylosing Spondylitis Functional Index (0-10, higher scores reflect higher degree of physical limitations), Baseline, 6 and 12 months after baseline (in patients with psoriatic arthritis and axial spondyloarthritis only)|VAS-global, Patients assessment of impact of the disease Visual Analogue Scale (0-100, higher scores reflect higher impact), Baseline, 6 and 12 months after baseline|ISI, Insomnia Severity Index (0-28, higher scores reflect worse sleep problems), Baseline, 6 and 12 months after baseline|PASS, Patient Acceptable Symptom State (yes/no), Baseline, 6 and 12 months after baseline
Other Outcome Measures: HLQ subscales 3 and 6, Health Literacy Questionnaire subscale 3 (Actively managing my health, 5-20, higher scores reflect higher Health Literacy) and suscale 6 (Ability to actively engage with healthcare providers (5-25, higher scores reflect higher Health Literacy), Baseline, 6 and 12 months after baseline|Smoking habits, Present, occational, previous or never smoker, amount per day, Baseline, 6 and 12 months after baseline|Alcohol habits, How many units do you drink per week?, How often do you drink? and How often do you drink five units or more on the same occation?, Baseline, 6 and 12 months after baseline