Supplemental Oxygen in Pulmonary Fibrosis

NCT ID: NCT01961362

Last Updated: 2020-02-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pulmonary fibrosis patients

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


O2 Prescribers

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pulmonary Fibrosis Foundation

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

National Jewish Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeff Swigris, DO, MS

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Jewish Health Interstitial Lung Disease Program

Denver, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29169394 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29166901 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28668090 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PCORI 4134a

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Real-Time Support for Exercise Persistence in COPD
NCT00373932 COMPLETED PHASE1/PHASE2