Supplemental Oxygen in Pulmonary Fibrosis

Pulmonary Fibrosis Clinical Trial

Official title:

Observing the Effects of Supplemental Oxygen on Patients With Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961362
• Other study ID #: PCORI 4134a
• Status: Completed
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2020
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United States	National Jewish Health Interstitial Lung Disease Program	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
National Jewish Health	Patient-Centered Outcomes Research Institute, Pulmonary Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   This is a link to the Current Studies page of pulmonaryfibrosisresearch.org. It contains information about the study and how to contact study personnel.