Clinical trial NCT01961362: Supplemental Oxygen in Pulmonary Fibrosis
Official title: Observing the Effects of Supplemental Oxygen on Patients With Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Fibrosis
Keywords: Pulmonary fibrosis
Interstitial lung disease
Connective tissue disease
Chronic hypersensitivity pneumonitis
Idiopathic pulmonary fibrosis
Pulmonary fibrosis of any cause
Primary supporters/caregivers
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Pulmonary Fibrosis Foundation
name: Patient-Centered Outcomes Research Institute
First posted: 2013-10-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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
* 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

Primary outcomes:
measure: Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen
timeFrame: UCSD SOB score at one month after being prescribed supplemental O2
Secondary outcomes:
measure: Change in Physical Component Summary (PCS) Score From the Medical Outcomes Study Short-Form, 36-item Questionnaire (SF-36).
timeFrame: One month after daily-use supplemental oxygen implementation
measure: Fatigue Severity Scale
timeFrame: One month after daily-use supplemental oxygen implementation
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health Interstitial Lung Disease Program
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Jeff Swigris, DO, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.