Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA) A Descriptive Randomized Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Insufficient language skills to discuss the topics in the intervention in Danish
- •In chemotherapy treatment for malignancies
结局指标
主要结局
Recruitment
时间窗: Assessed at 3 months
Recruitment rate will be assessed as the number of patients recruited out of the number of eligiable patients
Retention
时间窗: 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
时间窗: 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
次要结局
- Functional status measured by the Multi-Dimensional Health Assessment Questionnaire (MD-HAQ)(Assessed at baseline and 9 months)
- Health related quality of life measured by the EuroQol-5 Dimension (EQ5D)(Assessed at baseline and 9 months)
- Self-efficacy measured by the Arthritis specific self-efficacy measurement tool (ASES)(Assessed at baseline and 9 months)
- Physical activity measured by the Physical activity and sedentary time questionnaire (FAST)(Assessed at baseline and 9 months)
- Fatigue measured by the Bristol Reumatoid Arthritis Fatigue Questionnaire (BRAF)(Assessed at baseline and 9 months)
- Health Literacy was measured by the Health Literacy Questionnaire (HLQ)(Assessed at baseline and 9 months)
- Pain intensity measured by the Visual analog scale for pain (VAS)(Assessed at baseline and 9 months)
- Fatigue measured by the visual analog scale for fatigue (VAS-fatigue)(Assessed at baseline and 9 months)
- Disease activity SpA measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Assessed at baseline and 9 months)
- Illness perception measured by the Brief Illness Perception Questionnaire (B-IPQ)(Assessed at baseline and 9 months)
- Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)(Assessed at baseline and 9 months)
- Disease activity PsA measured by the the Disease Activity index for PSoriatic Arthritis (DAPSA).(Assessed at baseline and 9 months)
- Disease activity RA measured the Disease Activity Score in 28 joints (DAS28)(Assessed at baseline and 9 months)
研究者
Bente Appel Esbensen
Professor
Glostrup University Hospital, Copenhagen