Pulmonary Fibrosis
Conditions
Keywords
Pulmonary fibrosis, Interstitial lung disease, Connective tissue disease, Chronic hypersensitivity pneumonitis, Idiopathic pulmonary fibrosis, Pulmonary fibrosis of any cause, Primary supporters/caregivers
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.
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.
Interventions
None listed
Sponsors
Pulmonary Fibrosis Foundation
Patient-Centered Outcomes Research Institute
National Jewish Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Component Summary (PCS) Score From the Medical Outcomes Study Short-Form, 36-item Questionnaire (SF-36). | 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. |
| Fatigue Severity Scale | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
We enrolled 19 subjects.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Pulmonary Fibrosis Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 67.5 years STANDARD_DEVIATION 10.1 |
| Percentage of Predicted Forced Vital Capacity | 64.9 Percentage of predicted FVC STANDARD_DEVIATION 16.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 13 Participants |
| University of California San Diego Shortness of Breath Questionnaire | 32.9 units on a scale STANDARD_DEVIATION 14 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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.
Time frame: UCSD SOB score at one month after being prescribed supplemental O2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Fibrosis Patients | Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen | 0.9 points | Standard Deviation 8.7 |
p-value: 0.6t-test, 2 sided
p-value: <0.05Mixed Models Analysis
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.
Time frame: One month after daily-use supplemental oxygen implementation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Fibrosis Patients | Change in Physical Component Summary (PCS) Score From the Medical Outcomes Study Short-Form, 36-item Questionnaire (SF-36). | -0.07 units on a scale | Standard Error 1.2 |
p-value: <0.05Mixed Models Analysis
Secondary
Fatigue Severity Scale
The Fatigue Severity Scale is a 9-item questionnaire, scored from 9-63, with higher scores indicating more severe fatigue.
Time frame: One month after daily-use supplemental oxygen implementation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Fibrosis Patients | Fatigue Severity Scale | 5.2 units on a scale | Standard Error 2.4 |