Supplemental Oxygen in Pulmonary Fibrosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observing the Effects of Supplemental Oxygen on Patients With Pulmonary Fibrosis

Conditions
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Pulmonary Fibrosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary fibrosis patients<br>Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | UCSD SOB score at one month after being prescribed supplemental O2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | One month after daily-use supplemental oxygen implementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary fibrosis, Interstitial lung disease, Connective tissue disease, Chronic hypersensitivity pneumonitis, Idiopathic pulmonary fibrosis, Pulmonary fibrosis of any cause, Primary supporters/caregivers