Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA)
- Conditions
- Feasibility
- Interventions
- Behavioral: NISMA
- Registration Number
- NCT06063252
- Lead Sponsor
- Glostrup University Hospital, Copenhagen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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.
- Insufficient language skills to discuss the topics in the intervention in Danish
- In chemotherapy treatment for malignancies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group NISMA receive self-management intervention
- Primary Outcome Measures
Name Time Method Recruitment Assessed at 3 months Recruitment rate will be assessed as the number of patients recruited out of the number of eligiable patients
Retention Assessed at 9 months Retention rate will be assessed as the number of patients who wtihdrew from the study out of the total number of patients.
Adherence Assessed at 9 months Adherence to intervention protocol of the study assessed as the number of sessions attended out of the total number of sessions available
- Secondary Outcome Measures
Name Time Method Functional status measured by the Multi-Dimensional Health Assessment Questionnaire (MD-HAQ) Assessed at baseline and 9 months Functional status measured by the Multi-Dimensional Health Assessment Questionnaire. Score from 0-3. Higher score is more disability.
Health related quality of life measured by the EuroQol-5 Dimension (EQ5D) Assessed at baseline and 9 months Quality of life measured by the EuroQol-5 Dimension. measures the patient's self-rated health status. Ranging from -0.624 to 1, higher is better.
Self-efficacy measured by the Arthritis specific self-efficacy measurement tool (ASES) Assessed at baseline and 9 months Self-efficacy measured by the Arthritis specific self-efficacy measurement tool. Score from 1-10. Higher score is better
Physical activity measured by the Physical activity and sedentary time questionnaire (FAST) Assessed at baseline and 9 months Physical activity measured by the Physical activity and sedentary time questionnaire (FAST)
Fatigue measured by the Bristol Reumatoid Arthritis Fatigue Questionnaire (BRAF) Assessed at baseline and 9 months Fatigue measured by the Bristol Reumatoid Arthritis Fatigue Questionnaire (BRAF). It consists of 20 questions with four responses in four categories: physical fatigue, living with fatigue, cognitive fatigue, and emotional fatigue. Higher score is more fatigue.
Health Literacy was measured by the Health Literacy Questionnaire (HLQ) Assessed at baseline and 9 months Health Literacy was measured by the Health Literacy Questionnaire. Independent scales measuring health literacy on a continuous scale. Scores range between 1 to 4 (for first 5 scales) and 1 to 5 (for scales 6 to 9).
Pain intensity measured by the Visual analog scale for pain (VAS) Assessed at baseline and 9 months Pain measured by the Visual analog scale for pain. Score from 0-100. Higher score is more pain.
Fatigue measured by the visual analog scale for fatigue (VAS-fatigue) Assessed at baseline and 9 months Fatigue measured by the visual analog scale for fatigue (VAS-fatigue). Score from 0-100. Higher score is more fatigue.
Disease activity SpA measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Assessed at baseline and 9 months Disease activity in patients with spondyloarthritis, was measured by the Bath Ankylosing Spondylitis Disease Activity Index. The sum score ranges from 0 to 100 with higher values indicating more active disease
Illness perception measured by the Brief Illness Perception Questionnaire (B-IPQ) Assessed at baseline and 9 months Illness perception measured by the Brief Illness Perception Questionnaire. Score from 1-10. Higher is worse.
Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS) Assessed at baseline and 9 months Anxiety and depression measured by the Hospital Anxiety and Depression Scale. ). HADS is a 14-item questionnaire that assesses levels of anxiety and depression symptoms in medically ill patients in two 7-item sub-scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 or higher indicate the probable presence of a mood disorder. Symptoms of anxiety and depression were defined by scores of 8 or higher.
Disease activity PsA measured by the the Disease Activity index for PSoriatic Arthritis (DAPSA). Assessed at baseline and 9 months Disease activity in patients wiht psoriatic arthritis, was measured by the Disease Activity index for PSoriatic Arthritis. Composite measures, in which multiple aspects of the disease are combined in a total score of the level of disease activity. Higher is worse.
Disease activity RA measured the Disease Activity Score in 28 joints (DAS28) Assessed at baseline and 9 months Disease activity in rheumatoid arthritis, measured the Disease Activity Score in 28 joints with erythrocyte sedimentation rate. Composite measures, in which multiple aspects of the disease are combined in a total score of the level of disease activity. Higher is worse.
Trial Locations
- Locations (1)
Luise Holberg Lindgren
🇩🇰Glostrup, Region Hovedstaden, Denmark