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Clinical Trials/NCT01961362
NCT01961362
Completed
Not Applicable

Observing the Effects of Supplemental Oxygen on Patients With Pulmonary Fibrosis

National Jewish Health1 site in 1 country19 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Fibrosis
Sponsor
National Jewish Health
Enrollment
19
Locations
1
Primary Endpoint
Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
December 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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