Pulmonary FibrosisNCT01961362
Supplemental Oxygen in Pulmonary Fibrosis
An observational study of Pulmonary Fibrosis, run by National Jewish Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibrosis
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
Show all 17Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Jewish Health Interstitial Lung Disease Program
Denver, Colorado, 80206
About this study
Official title: Observing the Effects of Supplemental Oxygen on Patients With 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.
Read the 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.
- 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
- Medical subject headings
- Pulmonary Fibrosis, Lung Diseases, Interstitial, Connective Tissue Diseases, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary fibrosis patients | Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: One month after daily-use supplemental oxygen implementation
Fatigue Severity Scale
The Fatigue Severity Scale is a 9-item questionnaire, scored from 9-63, with higher scores indicating more severe fatigue.
Measured: One month after daily-use supplemental oxygen implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pulmonary Fibrosis Foundation, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Jeff Swigris, DO, MS, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961362
- Sponsor's protocol ID
- PCORI 4134a
- Status last verified
- Feb 2020
- First submitted
- 9 Oct 2013
- Last updated
- 25 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29169394Olson 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.
PubMed 29166901Graney 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.
PubMed 28668090
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observing the Effects of Supplemental Oxygen on Patients With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT01961362
- Acronym / sponsor ID
- PCORI 4134a
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Pulmonary Fibrosis Foundation, Patient-Centered Outcomes Research Institute
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Posted 25 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary fibrosis patients | – | –Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Fatigue Severity Scale
Time frame: One month after daily-use supplemental oxygen implementation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29169394Root 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.
- Derived from this study: PubMed 29166901Olson 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.
- Derived from this study: PubMed 28668090Graney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Swigris, DO, MS principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01961362, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.