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临床试验/NCT01961362
NCT01961362已完成不适用

Observing the Effects of Supplemental Oxygen on Patients With Pulmonary Fibrosis

National Jewish Health1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen

研究概览

简要总结

To enhance understanding of supplemental oxygen-its utility in and adoption by patients with pulmonary fibrosis-by examining how patients perceive it and by determining how perceptions and patient-centered outcome measures change from before to after supplemental oxygen is prescribed.

详细描述

The investigators aim to recruit patients with PF to participate in interviews and/or a one-year study of supplemental oxygen (O2). In the one-year study, the investigators will collect data before and for one year after PF patients are prescribed daily-use supplemental oxygen and compare outcomes, including shortness of breath, quality of life, fatigue, cough, and day-to-day functioning before and after O2.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient-Participants
  • (Using daily 02 therapy at time of enrollment)
  • Diagnosis of PF
  • Able to read and speak English
  • Has been on daily-use supplemental oxygen for more than one year
  • (Not using daily 02 therapy at time of enrollment)
  • Diagnosis of PF
  • Able to read, speak and write in English
  • Has not been prescribed daily-use supplemental oxygen
  • Forced vital capacity <75% and diffusing capacity <65% of predicted values
  • Subject's physician allows the subject to abstain from daily-use supplemental oxygen for 7-10 days after prescription to allow data for collection
  • Primary Supporters
  • Self-report status of providing care or support to a person living with pulmonary fibrosis who has used supplemental oxygen for more than one year
  • Able to speak English
  • O2 Prescribers
  • Self-report status of being a prescriber of daily-use supplemental oxygen to PF patients
  • Able to speak English

排除标准

  • Patient-Participants (Using daily 02 therapy at time of enrollment)
  • No diagnosis of PF
  • Unable to read and speak English
  • Has been on daily-use supplemental oxygen for less than one year
  • (Not using daily 02 therapy at time of enrollment)
  • No diagnosis of PF
  • Unable to read, speak and write in English
  • Using supplemental oxygen during the day
  • Subject's physician does not allow the subject to abstain from daily-use supplemental oxygen for 7-10 days after prescription to allow data for collection
  • Primary Supporters • Not meeting inclusion criteria
  • O2 Prescribers
  • Not meeting inclusion criteria

结局指标

主要结局

Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen

时间窗: UCSD SOB score at one month after being prescribed supplemental O2

The University of California San Diego Shortness of Breath Questionnaire (or UCSD SOB) is a tool that measures shortness of breath using 24 items, each with response options ranging from 0 to 5, corresponding to "None at all" and "Maximally or unable to do because of breathlessness." Thus, scores for the UCSD SOB range from 0 to 120, with higher scores indicating greater shortness of breath.

次要结局

  • Fatigue Severity Scale(One month after daily-use supplemental oxygen implementation)
  • Change in Physical Component Summary (PCS) Score From the Medical Outcomes Study Short-Form, 36-item Questionnaire (SF-36).(One month after daily-use supplemental oxygen implementation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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