Clinical trial NCT06063252: Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA)
Official title: Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA) A Descriptive Randomized Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This feasibility study is designed as a randomized controlled feasibility trial (allocation ratio 1:1)
Primary purpose: OTHER

Brief summary: Even though medical treatment has improved within the last 10-15 years, patients with inflammatory arthritis (IA) still experience reduced quality of life, depression, anxiety, changes in family roles, work life, and social relationships. Particularly the newly diagnosed, require regular consultations and available support from health professionals, to be able to handle emotional, social, and physiological challenges.

The hypothesis is that a self-management intervention can improve patients' ability to monitor their arthritis and respond to symptoms, reduce the risk of co-morbidities, and improve adherence. And also, that they can develop cognitive, behavioral, and emotional strategies to manage life with arthritis. There is a lack of disease-specific evidence, in integrated interventions with multiple components targeting patients with a newly diagnosed IA. In a previous study, the investigators developed a self-management intervention, and now wish to test it in a randomized feasibility study.

Detailed description: RATIONALE FOR NISMA PROJECT

The hypothesis is that a self-management intervention can help patients develop behavioral and emotional strategies to manage life with arthritis. There a lack of disease-specific evidence, in integrated interventions with multiple components targeting patients with a newly diagnosed IA. Therefore, the investigators wish to develop a self-management intervention.

Aim

The overall aim of this study is to determine whether a full-scale randomized controlled trial, which aims to increase self-management in patients with newly diagnosed IA, is possible. The investigators wish to identify methodological, clinical, and procedural uncertainties in delivering a self-management intervention. Furthermore, to investigate outcomes related to recruitment, including adherence, retention, accrual rate, characteristics of the sample, and reliable recruitment methods.

Design

This feasibility study is designed as a randomized controlled feasibility trial (allocation ratio 1:1) to assess the proposed method in the definitive RCT.

Overall Setting

The intervention will take place at the Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark.

Eligibility criteria: Inclusion Criteria:

* Adult persons (≥18 years)
* Diagnosed with one of the following diagnoses: Rheumatoid arthritis (ICD10 diagnoses: M05.3, M05.9, M05.8, M06.9), Spondyloarthritis (ICD10 diagnoses: M45.9, M46.1, M46.8, M46.9) or Psoriatic arthritis (ICD10 diagnoses: M073.A, M073.B), within the last 6 months.

Exclusion Criteria:

* Insufficient language skills to discuss the topics in the intervention in Danish
* In chemotherapy treatment for malignancies

Primary outcomes:
measure: Recruitment
timeFrame: Assessed at 3 months
measure: Retention
timeFrame: Assessed at 9 months
measure: Adherence
timeFrame: Assessed at 9 months
Secondary outcomes:
measure: Physical activity measured by the Physical activity and sedentary time questionnaire (FAST)
timeFrame: Assessed at baseline and 9 months
measure: Pain intensity measured by the Visual analog scale for pain (VAS)
timeFrame: Assessed at baseline and 9 months
measure: Functional status measured by the Multi-Dimensional Health Assessment Questionnaire (MD-HAQ)
timeFrame: Assessed at baseline and 9 months
measure: Fatigue measured by the Bristol Reumatoid Arthritis Fatigue Questionnaire (BRAF)
timeFrame: Assessed at baseline and 9 months
measure: Fatigue measured by the visual analog scale for fatigue (VAS-fatigue)
timeFrame: Assessed at baseline and 9 months
measure: Health Literacy was measured by the Health Literacy Questionnaire (HLQ)
timeFrame: Assessed at baseline and 9 months
measure: Health related quality of life measured by the EuroQol-5 Dimension (EQ5D)
timeFrame: Assessed at baseline and 9 months
measure: Illness perception measured by the Brief Illness Perception Questionnaire (B-IPQ)
timeFrame: Assessed at baseline and 9 months
measure: Self-efficacy measured by the Arthritis specific self-efficacy measurement tool (ASES)
timeFrame: Assessed at baseline and 9 months
measure: Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Assessed at baseline and 9 months
measure: Disease activity RA measured the Disease Activity Score in 28 joints (DAS28)
timeFrame: Assessed at baseline and 9 months
measure: Disease activity SpA measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Assessed at baseline and 9 months
measure: Disease activity PsA measured by the the Disease Activity index for PSoriatic Arthritis (DAPSA).
timeFrame: Assessed at baseline and 9 months
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Luise Holberg Lindgren
state: Region Hovedstaden
Study officials:
affiliation: Rigshospitalet, Glostrup, Center for Rheumatology and Spine Diseases. COPECARE
name: Bente A Esbensen, Professor
role: PRINCIPAL_INVESTIGATOR
References: