GotNet Study, The Gothenburg Nurse-led Tight Control Study
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
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Gothenburg、瑞典
- Sahlgrenska University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Regular care
The control-group is treated according to "care as usual" with visits to physician every 6th month.
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实验性的：Nurse-led clinic
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Disease activity score (DAS28)
大体时间：Baseline, week 26 and 50
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The primary outcome constitute of DAS28, an index comprising the number of tender and swollen joints, patients global health assessment and erythrocyte sedimentation rate
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Baseline, week 26 and 50
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of patients with low Disease activity score (DAS28)
大体时间：Baseline, week 26 and 50
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Baseline, week 26 and 50
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Proportion of patients with remisson according to Disease activity score (DAS28)
大体时间：Baseline, week 26 and 50
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Baseline, week 26 and 50
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Health assessment questionnaire (HAQ)
大体时间：Baseline, week 26 and 50
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Measures functional status
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Baseline, week 26 and 50
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EuroQol (EQ-5D)
大体时间：Baseline, week 26 and 50
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Measures health status, allowing computation of cost-effectiveness
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Baseline, week 26 and 50
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Visual analogue scale for pain (VAS-pain)
大体时间：Baseline, week 26 and 50
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Measures the patient's pain
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Baseline, week 26 and 50
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Visual analogue scale fatigue (VAS-Fatigue)
大体时间：Baseline, week 26 and 50
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Measures the patient's fatigue.
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Baseline, week 26 and 50
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Visual analogue scale general health (VAS-general health)
大体时间：Baseline, week 26 and 50
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Measures the patient's general health.
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Baseline, week 26 and 50
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Effective Consumer Survey 17 (EC17)
大体时间：Baseline, week 26 and 50
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Measures patients' perception of their knowledge, attitudes and behaviors about self-management skills
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Baseline, week 26 and 50
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Rheumatoid Arthritis Impact of Disease (RAID) score,
大体时间：Baseline, week 26 and 50
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A patient-derived composite measure of the impact of the disease
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Baseline, week 26 and 50
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The beliefs about medicines questionnaire (BMQ)
大体时间：Baseline,week 26 and 50
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Assessing patients' perceptions and expectation about medicines
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Baseline,week 26 and 50
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Numerical Rating Scale (NRS) about satisfaction with care
大体时间：Baseline, week 26 and 50
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Measures satisfaction with rheumatology care
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Baseline, week 26 and 50
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合作者和调查者
调查人员
- 首席研究员：Lennart Jacobsson, Professor、Göteborg University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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