Idiopathic Pulmonary FibrosisQUALY-IPF-PPPNCT04148157
Quality of Life in IPF - Patient and Physician Perceptions
An observational study of Idiopathic Pulmonary Fibrosis, run by University of Washington at 1 site in United States.
Trial summary
This study aims to evaluate the differences between patient's and their physicians' perception of quality of life and the effect of disease severity and co-morbidities. Patients and physicians will complete two sets of questionnaires at an initial clinic visit and again six months later. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants in this study will hold a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) as detailed above. As IPF occurs only in adults all subjects must be 18 years of age or older. Both men and women will be recruited for the study. Subjects of all ethnicities and racial minorities will be recruited. Physicians who are seeing these patients for regular clinical visits during the study will also be included.
Who may be able to join
- Patients with a multidisciplinary diagnosis of IPF according to the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guidelines.
- All ranges of disease severity based on pulmonary function testing: forced vital capacity (FVC) and diffusing capacity (DLCO).
Who cannot join
- Any impairment or co-morbid disease that results in an inability to read or understand a questionnaire or provide informed consent. The study team member will make this determination according to their best clinical judgement.
- The questionnaires will be administered in English language only and thus this study will be conducted in patients who are able to read, write, and speak English language.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington - Center for Interstitial Lung Disease
Seattle, Washington, 98195
About this study
Official title: Prospective, Observational Study of the Factors Affecting Patient and Physician Perceptions of Quality of Life in Idiopathic Pulmonary Fibrosis (IPF)
This study aims to evaluate the differences between patient's and their physicians' perception of quality of life and the effect of disease severity and co-morbidities. Patients and physicians will complete two sets of questionnaires at an initial clinic visit and again six months later.
Read the detailed description
Idiopathic Pulmonary Fibrosis is a progressive and debilitating disease characterized by progressive scarring of the lung parenchyma of unknown cause. In the US approximately 100,000 individuals have been diagnosed with this disease and the only cure available is lung transplantation. There have been two drugs approved by the FDA for treatment of IPF which have demonstrated the ability to slow disease progression but have no impact on quality of life.
Symptoms of IPF include shortness of breath, cough, and fatigue which all contribute to a decreased quality of life. Additionally, these symptoms and the need for supplemental oxygen use causes significant psychological and social impairment. Multiple questionnaires have been used to measure patient reported quality of life in both clinical and research settings. The King's Brief Interstitial Lung Disease (KBILD) Questionnaire is a disease-specific patient reported outcome measure and has been validated across several different patient groups and countries. Additionally, the EuroQol group has developed the EuroQol five dimensional 5-Level (EQ-5D-5L) questionnaire which is a non-disease specific assessment of health-related quality of life and has not yet been widely used in a population of patients with IPF.
Significant disparity between patient and physician perception of quality of life has been demonstrated across different disease processes. While there are many contributing factors to overall wellbeing the general assumption is that with more advanced disease quality of life predictably decreases. The investigators plan to test this hypothesis to better understand the complex relationship between chronic disease and quality of life in patients with IPF.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Quality of Life, Questionnaire
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Physician Responses to the Kings Brief ILD (K-BILD) Questionnaire
A comparison of physician and patient reported quality of life based on responses to the Kings Brief ILD Questionnaire (K-BILD). The domain and total score ranges are 0-100 where a score of 100 represents best health status.
Measured: 6 months
Patient and Physician Responses to the EuroQol five dimensional 5-Level (EQ-5D-5L) questionnaire
A comparison of physician and patient reported quality of life based on responses to the EuroQol five dimensional 5-Level (EQ-5D-5L) questionnaire. The domain ranges are 1-5 and the total score ranges are 5-25 where a score of 5 represents best health status. The visual analog scale portion of the questionnaire ranges from 0 to 100 where a score of 100 represents best health status.
Measured: 6 months
Patient and Physician Responses to the Raghu Quality of Life in Interstitial Lung Disease (RQ-LIFE-ILD) Questionnaire
A comparison of physician and patient reported quality of life based on responses to a novel visual analog scale questionnaire the Raghu Quality of Life in Interstitial Lung Disease (RQ-LIFE-ILD) Questionnaire. The domain ranges are 0 to 10 and the total score ranges are 0 to 50 where a score of 0 represents best health status.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start23 Sep 2019
- Primary completion27 Nov 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Washington Research Foundation
- Responsible party
- Principal investigator, Ganesh Raghu, University of Washington
- Investigators
- Ganesh Raghu, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148157
- Sponsor's protocol ID
- STUDY00008283
- Acronym
- QUALY-IPF-PPP
- Status last verified
- Dec 2024
- First submitted
- 25 Oct 2019
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scallan C, Strand L, Hayes J, Kadura S, Collins B, Ho L, Spada C, Canestaro W, Kolb M, Raghu G. R-scale for pulmonary fibrosis: a simple, visual tool for the assessment of health-related quality of life. Eur Respir J. 2022 Jan 13;59(1):2100917. doi: 10.1183/13993003.00917-2021. Print 2022 Jan.
PubMed 34112729
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study of the Factors Affecting Patient and Physician Perceptions of Quality of Life in Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT04148157
- Acronym / sponsor ID
- QUALY-IPF-PPP / STUDY00008283
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Quality of Life, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Washington Research Foundation
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the differences between patient's and their physicians' perception of quality of life and the effect of disease severity and co-morbidities. Patients and physicians will complete two sets of questionnaires at an initial clinic visit and again six months later.
Detailed description
Idiopathic Pulmonary Fibrosis is a progressive and debilitating disease characterized by progressive scarring of the lung parenchyma of unknown cause. In the US approximately 100,000 individuals have been diagnosed with this disease and the only cure available is lung transplantation. There have been two drugs approved by the FDA for treatment of IPF which have demonstrated the ability to slow disease progression but have no impact on quality of life.
Symptoms of IPF include shortness of breath, cough, and fatigue which all contribute to a decreased quality of life. Additionally, these symptoms and the need for supplemental oxygen use causes significant psychological and social impairment. Multiple questionnaires have been used to measure patient reported quality of life in both clinical and research settings. The King's Brief Interstitial Lung Disease (KBILD) Questionnaire is a disease-specific patient reported outcome measure and has been validated across several different patient groups and countries. Additionally, the EuroQol group has developed the EuroQol five dimensional 5-Level (EQ-5D-5L) questionnaire which is a non-disease specific assessment of health-related quality of life and has not yet been widely used in a population of patients with IPF.
Significant disparity between patient and physician perception of quality of life has been demonstrated across different disease processes. While there are many contributing factors to overall wellbeing the general assumption is that with more advanced disease quality of life predictably decreases. The investigators plan to test this hypothesis to better understand the complex relationship between chronic disease and quality of life in patients with IPF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants in this study will hold a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) as detailed above. As IPF occurs only in adults all subjects must be 18 years of age or older. Both men and women will be recruited for the study. Subjects of all ethnicities and racial minorities will be recruited. Physicians who are seeing these patients for regular clinical visits during the study will also be included.
Key inclusion criteria (2 listed)
- Patients with a multidisciplinary diagnosis of IPF according to the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guidelines.
- All ranges of disease severity based on pulmonary function testing: forced vital capacity (FVC) and diffusing capacity (DLCO).
Key exclusion criteria (2 listed)
- Any impairment or co-morbid disease that results in an inability to read or understand a questionnaire or provide informed consent. The study team member will make this determination according to their best clinical judgement.
- The questionnaires will be administered in English language only and thus this study will be conducted in patients who are able to read, write, and speak English language.
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
Patient and Physician Responses to the Kings Brief ILD (K-BILD) Questionnaire
Time frame: 6 months
A comparison of physician and patient reported quality of life based on responses to the Kings Brief ILD Questionnaire (K-BILD). The domain and total score ranges are 0-100 where a score of 100 represents best health status.
Patient and Physician Responses to the EuroQol five dimensional 5-Level (EQ-5D-5L) questionnaire
Time frame: 6 months
A comparison of physician and patient reported quality of life based on responses to the EuroQol five dimensional 5-Level (EQ-5D-5L) questionnaire. The domain ranges are 1-5 and the total score ranges are 5-25 where a score of 5 represents best health status. The visual analog scale portion of the questionnaire ranges from 0 to 100 where a score of 100 represents best health status.
Patient and Physician Responses to the Raghu Quality of Life in Interstitial Lung Disease (RQ-LIFE-ILD) Questionnaire
Time frame: 6 months
A comparison of physician and patient reported quality of life based on responses to a novel visual analog scale questionnaire the Raghu Quality of Life in Interstitial Lung Disease (RQ-LIFE-ILD) Questionnaire. The domain ranges are 0 to 10 and the total score ranges are 0 to 50 where a score of 0 represents best health status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Derived from this study: PubMed 34112729Scallan C, Strand L, Hayes J, Kadura S, Collins B, Ho L, Spada C, Canestaro W, Kolb M, Raghu G. R-scale for pulmonary fibrosis: a simple, visual tool for the assessment of health-related quality of life. Eur Respir J. 2022 Jan 13;59(1):2100917. doi: 10.1183/13993003.00917-2021. Print 2022 Jan.
- Individual participant dataSharing planned: No
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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.
Ganesh Raghu, MD principal investigator
University of Washington
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 Idiopathic Pulmonary Fibrosis, run by University of Washington 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 2 inclusion and 2 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 11 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient and Physician Responses to the Kings Brief ILD (K-BILD) Questionnaire (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT04148157, which also lists 1 linked publication.
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 11 Dec 2024.