Supplemental Oxygen in Pulmonary Fibrosis
- Conditions
- Pulmonary Fibrosis
- Registration Number
- NCT01961362
- Lead Sponsor
- National Jewish Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen 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 Outcome Measures
Name Time Method Fatigue Severity Scale One month after daily-use supplemental oxygen implementation The Fatigue Severity Scale is a 9-item questionnaire, scored from 9-63, with higher scores indicating more severe fatigue.
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 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.
Trial Locations
- Locations (1)
National Jewish Health Interstitial Lung Disease Program
🇺🇸Denver, Colorado, United States