Supplemental Oxygen in Pulmonary Fibrosis

N/ACompletedNCT01961362

National Jewish Health19 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Fibrosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * 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 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 O2 Prescribers • Not meeting inclusion criteria

Locations (1)

National Jewish Health Interstitial Lung Disease Program

Denver, Colorado, United States

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

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.

Time frame: UCSD SOB score at one month after being prescribed supplemental O2

Secondary Outcomes

Change in Physical Component Summary (PCS) Score From the Medical Outcomes Study Short-Form, 36-item Questionnaire (SF-36).

The PCS of the SF-36 assesses a domain of quality of life. Its scores range from 0-100, with higher scores indicating better quality of life on this domain.

Time frame: One month after daily-use supplemental oxygen implementation

Fatigue Severity Scale

The Fatigue Severity Scale is a 9-item questionnaire, scored from 9-63, with higher scores indicating more severe fatigue.

Time frame: One month after daily-use supplemental oxygen implementation

Data from ClinicalTrials.gov

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