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临床试验/NCT02122289
NCT02122289已完成1 期

Interest of the New Technologies to Detect précocément a Respiratory Exacerbation at Patients Reached by Cystic Fibrosis.

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
45
试验地点
2
主要终点
Frequency of exacerbation

研究概览

简要总结

Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present health costs burden leading to important physical psychological and social impact. Preventing exacerbation and early detection of these exacerbations may decrease intensity and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased health cost.

Patients actually follow in CRCM track exacerbations when visits out patient clinic and during phone call. If patients did not call or did not present regularly to out patient clinic, exacerbation detection came later and so increasde the burden and therapeutic pressure.

The objective of our study is to identify earlier the potential exacerbations and so decreased the health costs and increased the patient's QoL. Forthis purpose we propose to use modern technologiessuch as smartphone in order to create alert when patients report weekly health satatus. We will compra patients randomize in control group with standart follow-up to patients randomize in the smartphone group.Moreover we will study the compliance and satisfactory degree of the use of this device in the interventional arm.

详细描述

Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present health costs burden leading to important physical psychological and social impact. Preventing exacerbation and early detection of these exacerbations may decrease intensity and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased health cost.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
14 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •CF diagnosis
  • •Patient able to receive phone call
  • •Patient who use regulary a smartphone
  • •age from 14 to 25
  • •Patients with at least 2 exacerbations before the entry.
  • •Stable patient at V1

排除标准

  • •Patients who are include in an interventional study
  • •Patient who is not able to read French language
  • •Patients with psychological disorder

研究组 & 干预措施

Application of Smartphone

Experimental

Weekly questionnaire on Smartphone

干预措施: Application of Smartphone (Device)

No application Smartphone

Placebo Comparator

No Weekly questionnaire on Smartphone

干预措施: No application Smartphone (Other)

结局指标

主要结局

Frequency of exacerbation

时间窗: up to 6 months

次要结局

  • Satisfactory status and compliance(up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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