Effect of Patient Education in Rheumatic Diseases
2015年4月7日 更新者:Norwegian University of Science and Technology
The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.
The purpose of this study is to explore the effect of patient education (PE) in patients with arthritis. PE has become a task that is dictated by law in Norway, and is increasingly used as an element in the treatment of patients with chronic complaints. Our hypothesis is that
- PE delivered as group education, followed by an individual nurse consultation increases the patients wellbeing an ability to cope with the disease.
研究概览
详细说明
There has been a rather long tradition of PE for patients with arthritis.
A recent systematic review found that PE had small short-term effects on disability, joint counts, patient global assessment, psychological status and depression, but this effect disappeared on the latest time of follow up (3-14 months).
A recent large British study also failed to show an effect on pain, physical functioning, or contact with primary care after 12 months, but found a significant effect on anxiety and improved the participants' perceived self efficacy.
This indicates that the present forms of interventions fails to show a long term effect.
One possible reason for the lack of long term effect might be that these interventions are given to groups only.
Patients seem to prefer one-to-one interaction regarding information about the disease and its treatment together with emotional aspects, while education in groups are preferred for physical training and relational topics.
研究类型
介入性
注册 (实际的)
141
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
-
-
-
Trondheim、挪威、7489
- Norwegian University of Science and Technology and St. Olavs Hospital HF
-
-
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 至 80年 (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:
- Polyarthritis
- 18-80 years
- native Norwegian speaking
- able to understand and participate in the PE program
Exclusion Criteria:
- Participated in a patient educational program the latest 12 months
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
- 主要用途:卫生服务研究
- 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 |
|---|---|
|
无干预:2个
日常护理
|
|
|
实验性的:1
Patient education
|
3 group meetings followed by 1-2 individual nurse consultations.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Self efficacy
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Well being (Arizona Integrative Outcomes Scale)
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
The Hospital Anxiety and Depression Scale
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Educational Needs Assessment Tools
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Modified Health Assessment Questionnaire
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
DAS 28 score (Disease activity score)
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Patient Activation Measurement (PAM)
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Cost- benefit
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Physical activity
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Use of medications
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
fatigue (VAS scale)
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Pain (VAS scale)
大体时间:Baseline, 4 and 12 months
|
Baseline, 4 and 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:Aslak Steinsbekk、Norwegian University of Science and Technology
- 首席研究员:Kjersti Grønning、Norwegian University of Science and Technology
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Riemsma RP, Taal E, Kirwan JR, Rasker JJ. Systematic review of rheumatoid arthritis patient education. Arthritis Rheum. 2004 Dec 15;51(6):1045-59. doi: 10.1002/art.20823. No abstract available.
- Gronning K, Skomsvoll JF, Rannestad T, Steinsbekk A. The effect of an educational programme consisting of group and individual arthritis education for patients with polyarthritis--a randomised controlled trial. Patient Educ Couns. 2012 Jul;88(1):113-20. doi: 10.1016/j.pec.2011.12.011. Epub 2012 Jan 23.
- Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.
- Gronning K, Midttun L, Steinsbekk A. Patients' confidence in coping with arthritis after nurse-led education; a qualitative study. BMC Nurs. 2016 May 4;15:28. doi: 10.1186/s12912-016-0150-x. eCollection 2016.
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
2008年2月1日
初级完成 (实际的)
2010年3月1日
研究完成 (实际的)
2010年3月1日
研究注册日期
首次提交
2008年2月12日
首先提交符合 QC 标准的
2008年2月24日
首次发布 (估计)
2008年2月26日
研究记录更新
最后更新发布 (估计)
2015年4月8日
上次提交的符合 QC 标准的更新
2015年4月7日
最后验证
2015年4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.