Supplemental Oxygen in Pulmonary Fibrosis

Observing the Effects of Supplemental Oxygen on Patients With Pulmonary Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Fibrosis

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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health Interstitial Lung Disease Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary fibrosis of any cause (idiopathic, related to connective tissue disease [e.g., rheumatoid arthritis, systemic sclerosis/scleroderma, dermato-/polymyositis, sjogren's syndrome], familial or genetic) or the primary supporter/caregiver of a patient with pulmonary fibrosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pulmonary fibrosis patients; Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Patient-Centered Outcomes Research Institute; Pulmonary Fibrosis Foundation
• Investigators: Principal Investigator: Jeff Swigris, DO, MS, National Jewish Health

Publications and helpful links

General Publications

• Root ED, Graney B, Baird S, Churney T, Fier K, Korn M, McCormic M, Sprunger D, Vierzba T, Wamboldt FS, Swigris JJ. Physical activity and activity space in patients with pulmonary fibrosis not prescribed supplemental oxygen. BMC Pulm Med. 2017 Nov 23;17(1):154. doi: 10.1186/s12890-017-0495-2.
• Olson AL, Graney B, Baird S, Churney T, Fier K, Korn M, McCormick M, Sprunger D, Vierzba T, Wamboldt FS, Swigris JJ. Tracking dyspnea up to supplemental oxygen prescription among patients with pulmonary fibrosis. BMC Pulm Med. 2017 Nov 22;17(1):152. doi: 10.1186/s12890-017-0497-0.
• Graney BA, Wamboldt FS, Baird S, Churney T, Fier K, Korn M, McCormick M, Vierzba T, Swigris JJ. Informal caregivers experience of supplemental oxygen in pulmonary fibrosis. Health Qual Life Outcomes. 2017 Jul 1;15(1):133. doi: 10.1186/s12955-017-0710-0.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Idiopathic pulmonary fibrosis; Interstitial lung disease; Pulmonary fibrosis; Connective tissue disease; Chronic hypersensitivity pneumonitis; Pulmonary fibrosis of any cause; Primary supporters/caregivers
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis
• Other Study ID Numbers: PCORI 4134a