Supplemental Oxygen in Pulmonary Fibrosis

NCT01961362 | Completed Results DMC

• 1 other identifier: PCORI 4134a
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Fatigue Severity Scale

  One month after daily-use supplemental oxygen implementation

Study Arms (1)

Pulmonary fibrosis patients

Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• O2 Prescribers

Sponsors & Collaborators

• National Jewish Health: lead
• Pulmonary Fibrosis Foundation: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

National Jewish Health Interstitial Lung Disease Program

Denver, Colorado, 80206, United States

Location

Related Publications (3)

• 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.

  PMID: 29169394 DERIVED

• 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.

  PMID: 29166901 DERIVED

• 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.

  PMID: 28668090 DERIVED

MeSH Terms

Conditions

Pulmonary Fibrosis; Lung Diseases, Interstitial; Connective Tissue Diseases; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases

Limitations and Caveats

Fewer patients than expected were prescribed supplemental O2 by their practitioners; thus, our study was under-powered for the primary and secondary outcome assessments.

Results Point of Contact

• Title: Dr. Jeffrey J. Swigris
• Organization: National Jewish Health

swigrisj@njhealth.org

303-398-1621

Study Officials

• Jeff Swigris, DO, MS

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 25, 2020
• Results First Posted: February 25, 2020

Record last verified: 2020-02

Locations

US (1)