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Supplemental Oxygen in Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01961362
Recruitment Status : Completed
First Posted : October 11, 2013
Results First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
Pulmonary Fibrosis Foundation
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
National Jewish Health

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observing the Effects of Supplemental Oxygen on Patients With Pulmonary Fibrosis
Study Start Date : October 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


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



Primary Outcome Measures :
  1. Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen [ Time Frame: UCSD SOB score at one month after being prescribed supplemental O2 ]
    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.


Secondary Outcome Measures :
  1. Change in Physical Component Summary (PCS) Score From the Medical Outcomes Study Short-Form, 36-item Questionnaire (SF-36). [ Time Frame: One month after daily-use supplemental oxygen implementation ]
    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.

  2. Fatigue Severity Scale [ Time Frame: One month after daily-use supplemental oxygen implementation ]
    The Fatigue Severity Scale is a 9-item questionnaire, scored from 9-63, with higher scores indicating more severe fatigue.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961362


Locations
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United States, Colorado
National Jewish Health Interstitial Lung Disease Program
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Pulmonary Fibrosis Foundation
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Jeff Swigris, DO, MS National Jewish Health

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT01961362    
Other Study ID Numbers: PCORI 4134a
First Posted: October 11, 2013    Key Record Dates
Results First Posted: February 25, 2020
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by National Jewish Health:
Pulmonary fibrosis
Interstitial lung disease
Connective tissue disease
Chronic hypersensitivity pneumonitis
Idiopathic pulmonary fibrosis
Pulmonary fibrosis of any cause
Primary supporters/caregivers
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases