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临床试验/NCT02694926
NCT02694926已完成不适用

National (German-wide) Education Programme for Patients With Chronic Adrenal Insufficiency

Wuerzburg University Hospital2 个研究点 分布在 1 个国家目标入组 528 人开始时间: 2014年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
528
试验地点
2
主要终点
Efficiency of education evaluated by questionnaire.

研究概览

简要总结

Even under established replacement therapy, patients with adrenal insufficiency still suffer from impaired quality of life and experience adrenal crises. Patient education is regarded as important preventive measure. In this study a german-wide standardized education Programme will be evaluated.

详细描述

Design aspects:

In a prospective trial the efficiency of a german-wide education programme in patients with chronic adrenal insufficiency will be evaluated by using a questionnaire before and after training.

Patients:

Patients will be recruited out of the patient population of the participating nine medical centers. To achieve a anticipated number of 450 patients, each center will include al least 50 patients with chronic adrenal insufficiency under established replacement therapy .

Trial flow:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • Age > 18 years
  • patient's written informed consent
  • Ability to comply with the protocol procedures
  • patients with primary or secondary adrenal insufficiency under established stable replacement therapy

排除标准

  • 未提供

研究组 & 干预措施

adrenal insufficiency

Other

干预措施: Education (Other)

结局指标

主要结局

Efficiency of education evaluated by questionnaire.

时间窗: 12-24 months

To evaluate the efficiency of the education programme patients complete three questionnaires. Questionnaires asses the general knowledge on adrenal insufficiency and the correct behavior in emergency settings via multiple choice questions. Overall scores before and after training will be compared

次要结局

  • Patient satisfaction /safety evaluated by questionnaire.(12-24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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