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| Name | Class |
|---|---|
| Pulmonary Fibrosis Foundation | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary fibrosis patients | Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Patient-Participants
(Using daily 02 therapy at time of enrollment)
(Not using daily 02 therapy at time of enrollment)
Primary Supporters
O2 Prescribers
Exclusion Criteria:
Patient-Participants (Using daily 02 therapy at time of enrollment)
(Not using daily 02 therapy at time of enrollment)
Primary Supporters • Not meeting inclusion criteria
O2 Prescribers
• Not meeting inclusion criteria
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Swigris, DO, MS | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health Interstitial Lung Disease Program | Denver | Colorado | 80206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29169394 | Derived | 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. | |
| 29166901 | Derived |
| Label | URL |
|---|---|
| This is a link to the Current Studies page of pulmonaryfibrosisresearch.org. It contains information about the study and how to contact study personnel. | View source |
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We enrolled 19 subjects.
We enrolled patients with PF not using supplemental O2 and then followed them forward until they were prescribed supplemental O2 by their treating practitioner, and then we followed them for an additional 12 months after being prescribed O2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulmonary Fibrosis Patients | Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We enrolled patients with PF not using supplemental O2 and then followed them forward until they were prescribed supplemental O2 by their treating practitioner, and then we followed them for an additional 12 months after being prescribed O2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulmonary Fibrosis Patients | Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis). We enrolled patients with PF not using supplemental O2 and then followed them forward until they were prescribed supplemental O2 by their treating practitioner, and then we followed them for an additional 12 months after being prescribed O2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age of the subjects |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | points | UCSD SOB score at one month after being prescribed supplemental O2 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pulmonary Fibrosis Patients | Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis) |
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Fewer patients than expected were prescribed supplemental O2 by their practitioners; thus, our study was under-powered for the primary and secondary outcome assessments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey J. Swigris | National Jewish Health | 303-398-1621 | swigrisj@njhealth.org |
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D003240 | Connective Tissue Diseases |
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| 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 |
| 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. |
| 28668090 | Derived | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Percentage of Predicted Forced Vital Capacity | Mean | Standard Deviation | Percentage of predicted FVC |
|
| University of California San Diego Shortness of Breath Questionnaire | 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. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | 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. | Posted | Mean | Standard Error | units on a scale | One month after daily-use supplemental oxygen implementation |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017437 | Skin and Connective Tissue Diseases |