More Added Value of Therapeutic Education in the Management of Patients With Rheumatoid Arthritis (ETP-PR) (ETP-PR)
2016年8月5日 更新者：Nantes University Hospital
More Added Value of Therapeutic Education in the Management of Patients With Rheumatoid Arthritis
Taking into account the recommendations of the Health Authority [1] and the application of patients' associations, we have structured a course of therapeutic education includes three stages for patients with rheumatoid arthritis and followed at Nantes University Hospital.
Step 1: initial interview with a nurse patient education for diagnosis and education with the patient to choose three subjects from among 10 offered him problematic; Step 2: Orientation in an educational path that provides access to 6 months group workshops (3 maximum) and / or interviews tailored to the three selected topics; Step 3: final interview with a nurse said therapeutic education formative assessment to take stock.
The main objective of our work is to ensure that the patient finds it easier solutions to the three problematic topics him after 6 months of education after six months without treatment.
研究概览
研究类型
介入性
注册 (实际的)
62
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Nantes、法国、44000
- Maugars
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patient presenting at clinics for Rheumatology or the Rheumatology Day Hospital at the University Hospital or hospitalized in the department of Rheumatology
- Men or women
- Having signed the consent
- major
- Affiliated to social security or covered by the CMU
- Patient with rheumatoid arthritis meeting the ACR criteria
- Patient with rheumatoid arthritis stable for at least 6 months (change in DAS 28 <1.2)
Exclusion Criteria:
- Patient can not understand the information
- Patient confined to bed or chair, unable to care for himself or not doing with difficulty
- pregnant patient
- minors
- Adults under guardianship
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 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 |
|---|---|
|
其他：Immediate Education therapeutic
Access to the course of immediate therapeutic education
|
Access to the course of immediate therapeutic education
|
|
其他：therapeutic education delayed
Group receiving therapeutic education 6 months later (control group)
|
Group receiving therapeutic education 6 months later (control group)
|
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 |
|---|---|---|
|
EVA measures the overall ability to find solutions applicable to their situation
大体时间：12 months
|
Investigate whether, overall, the patient is more easily applicable solutions to the situation after six months of therapeutic education after six months without therapeutic education for three problems identified after the initial filling of the questionnaire (controls ) and after the initial interview with the nurse (test group)
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
EVA measures the ability to find solutions applicable to their situation for each of the three problems identified.
大体时间：12 months
|
Ability to find solutions applicable to their situation for each of the three problems identified
|
12 months
|
|
Knowledge (score / 10) treatments for rheumatoid arthritis, knowledge (note/10) signs of a flare of rheumatoid arthritis.
大体时间：12 months
|
Skills that we consider indispensable
|
12 months
|
|
Self-efficacy against a disease flare (EVA), self-efficacy against a side effect of treatment (EVA)
大体时间：12 months
|
Perceived self-efficacy compared to rheumatoid arthritis
|
12 months
|
|
RAPID score 4 (scale)
大体时间：12 months
|
Scalability of rheumatoid arthritis
|
12 months
|
|
EVA measuring fatigue
大体时间：12 months
|
Fatigue
|
12 months
|
|
Duration of morning stiffness in minutes or hours.
大体时间：12 months
|
Duration of stiffness
|
12 months
|
|
CRP and VS
大体时间：12 months
|
Biological criteria
|
12 months
|
|
Scale of STAI S Scale of STAI S
大体时间：12 months
|
Anxiety
|
12 months
|
|
Beck Scale
大体时间：12 months
|
Depression
|
12 months
|
|
Evaluation Test of adherence of Girerd
大体时间：12 months
|
Observance
|
12 months
|
|
Dosage Cortancyl or Solupred.
大体时间：12 months
|
Use of steroids
|
12 months
|
|
Number of visits to physician, rheumatologist at at therapist, psychiatrist, occupational physician, number of hospitalizations, number of meetings with occupational therapist, social worker, dietician, physiotherapist, psychologist...
大体时间：12 months
|
Consumption of medical and paramedical
|
12 months
|
|
Patient satisfaction with respect to information received, the caller and the improvement in different areas of health (EVA)
大体时间：12 months
|
Satisfaction with patient education
|
12 months
|
|
Attendance at meetings / workshops offered after the initial diagnosis.
大体时间：12 months
|
Membership
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Yves Maugars, PU-PH、CHU de Nantes
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年9月1日
初级完成 (实际的)
2012年2月1日
研究完成 (实际的)
2012年2月1日
研究注册日期
首次提交
2012年3月21日
首先提交符合 QC 标准的
2012年3月23日
首次发布 (估计)
2012年3月27日
研究记录更新
最后更新发布 (估计)
2016年8月8日
上次提交的符合 QC 标准的更新
2016年8月5日
最后验证
2016年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.