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Completed

NCT Number: NCT01961362

Supplemental Oxygen in Pulmonary Fibrosis

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health Interstitial Lung Disease Program

Denver, Colorado, 80206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • Pulmonary Fibrosis Foundation

Registry information

Official study title

Observing the Effects of Supplemental Oxygen on Patients With Pulmonary Fibrosis

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 11, 2013
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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