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临床试验/NCT04687475
NCT04687475已完成不适用

Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年4月20日最近更新:
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
10
试验地点
1
主要终点
Lung Allocation Score (LAS)

研究概览

简要总结

Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

详细描述

The aim of this project is to implement a clinical tool utilizing predictors of mortality for patients with Cystic Fibrosis (CF) on the waiting list to identify candidates that should present for urgent medical care and, if appropriate, will prompt clinicians to update a candidate's lung allocation score (LAS), the score used to prioritize lung transplant candidates for transplant by medical urgency, and avoid undetected decline. The clinical tool consists of home spirometry measures and patient reported outcomes that is completed weekly on a mobile application device used clinically to track spirometry.

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

  • Diagnosis of Cystic Fibrosis
  • To be listed for lung transplant
  • Has purchased home spirometer

排除标准

  • Diagnosis other than Cystic Fibrosis
  • Unable to read
  • Unable to use computer or smartphone device to access mobile application

研究组 & 干预措施

Clinical Tool (Mobile Spirometry and Survey)

Experimental

All subjects enrolled will be placed into the clinical tool arm. The clinical tool is comprised of a mobile application based assessment of home spirometry and a survey measuring patient reported outcomes.

干预措施: Clinical Tool (Mobile Spirometry and Survey) (Other)

结局指标

主要结局

Lung Allocation Score (LAS)

时间窗: Through study completion, an average of 3-6 months (time spent on the lung transplant waiting list).

Change in LAS value at the first clinic visit triggered by the clinical tool

次要结局

  • Time to transplant(Through study completion, up to 1 year)
  • Survival to transplant(Through study completion, up to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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