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临床试验/NCT03984422
NCT03984422招募中不适用

Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Satisfaction assessed by a 5-points Likert scales about using the application for the monitoring and evaluation of Raynaud's Phenomenon

研究概览

简要总结

To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary or secondary Raynaud phenomenon clinically diagnosed by a physician
  • Phone compatible with the application (most Android smartphones)
  • Non-opposition of participation in the study
  • Affiliation to the social security scheme or beneficiary of such a scheme

排除标准

  • Subject under administrative or judicial supervision
  • Subject not speaking and not understanding French

结局指标

主要结局

Satisfaction assessed by a 5-points Likert scales about using the application for the monitoring and evaluation of Raynaud's Phenomenon

时间窗: 2 weeks

The questionnaire assesses different items such as the ease of use of the application, the installation process on the smartphone, the use of reminders, etc. Overall satisfaction will be calculated as the non-weighted average of all items.

次要结局

  • Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks(2 weeks)
  • Relationship between cutaneous digital temperature assessed by thermography and the severity of Raynaud's Phenomenon(2 weeks)
  • Relationship between cutaneous digital temperature assessed by thermography and the duration of RP attacks(2 weeks)
  • Relationship between cutaneous digital temperature assessed by thermography and pain during RP attacks(2 weeks)
  • Effect of Raynaud etiology on thermographic data(2 weeks)
  • Effect of Raynaud treatment on thermographic data(2 weeks)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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