A Randomized, Controlled Study Evaluating the Efficacy of Person-centered, Tight Control Nurse-led Clinic of Patients With Established Rheumatoid Arthritis and Moderate to High Disease Activity Compared to Patients Receiving Regular Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Disease activity score (DAS28)
研究概览
简要总结
Purpose: To compare a nurse-led clinic including person-centered care and tight control with "care as usual" in patients with rheumatoid arthritis (RA) and moderate/ high disease activity.
Project description: Study population: Patients with RA, 18-80 yrs old, with moderate/ high Disease Activity Score of 28 joints (DAS28 > 3.8) and disease duration > 2 yrs in a 6-month randomized controlled study with a 6 month open follow-up. Intervention group (N=60): Nurse-led visits every 6th week, with structured person-centered care and evaluation of disease activity. If disease remission is not reached, pharmacological treatment including both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and biologics) is modified according to a predefined algorithm. The control group (N=60) is treated according to "care as usual" with visits to physician every 6th month. Outcome measures: Primary outcome measure is change in Diseases Activity Score (DAS). Secondary outcomes are quality of life, self-efficacy, disability, emotional well-being, pain, fatigue, sleep and satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 and <80 years of age
- •Signed and dated informed consent form before the start of any specific protocol procedures
- •Fulfill the 1987 ACR criteria or the 2010 ACR/EULAR criteria for RA with disease duration of >2 years
- •Moderate to high disease activity (DAS28 >3.8)
- •≥2 swollen joints
排除标准
- •Diagnosis of any other inflammatory arthritis
- •History of chronic infection, recent serious or life-threatening infection within 6 months
- •Concurrent malignancy, a history of malignancy or current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
结局指标
主要结局
Change in Disease activity score (DAS28)
时间窗: Baseline, week 26 and 50
The primary outcome constitute of DAS28, an index comprising the number of tender and swollen joints, patients global health assessment and erythrocyte sedimentation rate
次要结局
- Visual analogue scale general health (VAS-general health)(Baseline, week 26 and 50)
- Proportion of patients with low Disease activity score (DAS28)(Baseline, week 26 and 50)
- Health assessment questionnaire (HAQ)(Baseline, week 26 and 50)
- Effective Consumer Survey 17 (EC17)(Baseline, week 26 and 50)
- Rheumatoid Arthritis Impact of Disease (RAID) score,(Baseline, week 26 and 50)
- The beliefs about medicines questionnaire (BMQ)(Baseline,week 26 and 50)
- Numerical Rating Scale (NRS) about satisfaction with care(Baseline, week 26 and 50)
- Proportion of patients with remisson according to Disease activity score (DAS28)(Baseline, week 26 and 50)
- EuroQol (EQ-5D)(Baseline, week 26 and 50)
- Visual analogue scale for pain (VAS-pain)(Baseline, week 26 and 50)
- Visual analogue scale fatigue (VAS-Fatigue)(Baseline, week 26 and 50)
研究者
Ulrika Bergsten
RN, PHD
Vastra Gotaland Region