Idiopathic Pulmonary FibrosisIPFLifeNCT06629623
Current Status of Diagnosis, Treatment and Quality of Life for Patients with Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis, run by Chu Hongling at 1 site in China.
Trial summary
The goal of this observational study is to explore current status of diagnosis, treatment and quality of life for patients with idiopathic pulmonary fibrosis. It aims to integrate qualitative and quantitative data to describe the distribution of perspective, experience, patient journey, treatment, expectation and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2024to 30 Dec 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Under meeting the above inclusion and exclusion criteria, patients will be selected from Peking University Third Hospital, Beijing Chaoyang Hospital, Shenzhen Peking University-Hong Kong University of Science and Technology Medical Center, Zhejiang Chinese medical University, and West China Hospital of Sichuan University. Additionally, to ensure geographic representation of the patients, some participants will be recruited from a patient organization called "Take a Deep Breath for Love". A total of 295 IPF patients and 15 physicians are expected to represent six regions of the country, including Northeast, North China, Northwest, East China, Central South, and Southwest.
Who may be able to join
- IPF patients who are diagnosed according to international guidelines.
- Physicians who are clinical experts with extensive experience in the treatment of IPF.
Who cannot join
- The patient is unable to express his/her opinion clearly.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
The goal of this observational study is to explore current status of diagnosis, treatment and quality of life for patients with idiopathic pulmonary fibrosis. It aims to integrate qualitative and quantitative data to describe the distribution of perspective, experience, patient journey, treatment, expectation and quality of life for patients with idiopathic pulmonary fibrosis.
Participants will be invited to participate the interview, and answer quantitative survey questions about their quality of life.
Read the detailed description
Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, fibrotic interstitial lung disease of unknown aetiology primarily affecting middle-aged and elderly patients, more men than women. Median survival is 3∼5 years from the time of diagnosis. The prognosis is worse than for most common malignancies. However, patients' experiences, quality of life and needs during the disease course, have not been adequately investigated, which leads a lack of evidence to support the priority of treatment or drug development.
This study plans to conduct an mixed methods research to integrate qualitative and quantitative data to explore the perspective, experience, patient journey, treatment, expectation and quality of life for patients with idiopathic pulmonary fibrosis. For qualitative interview, there are 50 patients with idiopathic pulmonary fibrosis, and 15 physicians will be interviewed. For quantitative survey, there are 245 patients with idiopathic pulmonary fibrosis will be involved.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- No intervention
- Keywords
- Idiopathic pulmonary fibrosis, rare disease, quality of life, mixed methods
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with IPF | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unmet patient needs
Unmet patient needs primarily focus on the unmet clinical demands and expectations of IPF patients regarding their understanding and awareness of the disease, diagnosis, treatment methods, and patient management and care.
Measured: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey
Patient journey
The patient journey primarily focuses on the entire process of IPF patients from the discovery of uncomfortable symptoms, diagnosis, and treatment to follow-up. By mapping the patient journey, we can identify the gaps between patients' expected experiences and their actual experiences at each stage, recognize and address common pain points, and gain insights into the value drivers behind patient decisions. This approach helps healthcare institutions to gain frontline perspectives on patient experiences in a timely manner, optimize disease diagnosis and treatment processes, develop scientifically sound treatment plans, and even assist in designing or enhancing mobile healthcare management solutions for patients.
Measured: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey.
Quality of life
Quality of life primarily focuses on the impact of patients' physical and psychological health, as well as symptoms, and impact for their daily lives. Quality of life will be qualitatively deeply explore by interview, and quantitatively survey using EuroQol Five Dimensions Questionnair (EQ-5D) among patients with idiopathic pulmonary fibrosis.
Measured: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start30 Jul 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chu Hongling
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Beijing Chao Yang Hospital, Zhejiang Chinese Medical University, West China Hospital, Peking University Shenzhen Hospital
- Responsible party
- Sponsor-investigator, Chu Hongling, Peking University Third Hospital
- Investigators
- Hongling Chu, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629623
- Sponsor's protocol ID
- M2024203
- Acronym
- IPFLife
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a deeply exploration study about rare disease in China, which will integrate qualitative and quantitative data to answer the research question. This IPD data could not be shared. If some researchers plan to request IPD data, who could send email to the investigators. the investigators will review the request and send the available data.
Publications
Kreuter M, Swigris J, Pittrow D, Geier S, Klotsche J, Prasse A, Wirtz H, Koschel D, Andreas S, Claussen M, Grohe C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Glaser S, Herth FJF, Welte T, Neurohr C, Schwaiblmair M, Held M, Bahmer T, Frankenberger M, Behr J. Health related quality of life in patients with idiopathic pulmonary fibrosis in clinical practice: insights-IPF registry. Respir Res. 2017 Jul 14;18(1):139. doi: 10.1186/s12931-017-0621-y.
PubMed 28709421Chu H, Ding Y, Zhou Y, Ji P, Yuan B, Zhan X, Lu X, Liu N, Zhang Y, Yan B, Fang X, Xu X, Huang Z, Li W, Shen N, Zhan S. Patient journey and Quality of Life for Patients with Idiopathic Pulmonary Fibrosis (IPFLife) in China: a sequential exploratory mixed methods research protocol. BMJ Open. 2025 Aug 12;15(8):e098770. doi: 10.1136/bmjopen-2025-098770.
PubMed 40803740
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Status of Diagnosis, Treatment and Quality of Life for Patients with Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06629623
- Acronym / sponsor ID
- IPFLife / M2024203
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic pulmonary fibrosis, rare disease, quality of life, mixed methods
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Chu HonglingUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, Beijing Chao Yang Hospital, Zhejiang Chinese Medical University, West China Hospital, Peking University Shenzhen Hospital
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Oct 2024 (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.
The goal of this observational study is to explore current status of diagnosis, treatment and quality of life for patients with idiopathic pulmonary fibrosis. It aims to integrate qualitative and quantitative data to describe the distribution of perspective, experience, patient journey, treatment, expectation and quality of life for patients with idiopathic pulmonary fibrosis.
Participants will be invited to participate the interview, and answer quantitative survey questions about their quality of life.
Detailed description
Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, fibrotic interstitial lung disease of unknown aetiology primarily affecting middle-aged and elderly patients, more men than women. Median survival is 3∼5 years from the time of diagnosis. The prognosis is worse than for most common malignancies. However, patients' experiences, quality of life and needs during the disease course, have not been adequately investigated, which leads a lack of evidence to support the priority of treatment or drug development.
This study plans to conduct an mixed methods research to integrate qualitative and quantitative data to explore the perspective, experience, patient journey, treatment, expectation and quality of life for patients with idiopathic pulmonary fibrosis. For qualitative interview, there are 50 patients with idiopathic pulmonary fibrosis, and 15 physicians will be interviewed. For quantitative survey, there are 245 patients with idiopathic pulmonary fibrosis will be involved.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with IPF | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Under meeting the above inclusion and exclusion criteria, patients will be selected from Peking University Third Hospital, Beijing Chaoyang Hospital, Shenzhen Peking University-Hong Kong University of Science and Technology Medical Center, Zhejiang Chinese medical University, and West China Hospital of Sichuan University. Additionally, to ensure geographic representation of the patients, some participants will be recruited from a patient organization called "Take a Deep Breath for Love". A total of 295 IPF patients and 15 physicians are expected to represent six regions of the country, including Northeast, North China, Northwest, East China, Central South, and Southwest.
Key inclusion criteria (2 listed)
- IPF patients who are diagnosed according to international guidelines.
- Physicians who are clinical experts with extensive experience in the treatment of IPF.
Key exclusion criteria (1 listed)
- The patient is unable to express his/her opinion clearly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Patients with IPF |
Primary outcome
Unmet patient needs
Time frame: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey
Unmet patient needs primarily focus on the unmet clinical demands and expectations of IPF patients regarding their understanding and awareness of the disease, diagnosis, treatment methods, and patient management and care.
Patient journey
Time frame: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey.
The patient journey primarily focuses on the entire process of IPF patients from the discovery of uncomfortable symptoms, diagnosis, and treatment to follow-up. By mapping the patient journey, we can identify the gaps between patients' expected experiences and their actual experiences at each stage, recognize and address common pain points, and gain insights into the value drivers behind patient decisions. This approach helps healthcare institutions to gain frontline perspectives on patient experiences in a timely manner, optimize disease diagnosis and treatment processes, develop scientifically sound treatment plans, and even assist in designing or enhancing mobile healthcare management solutions for patients.
Quality of life
Time frame: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey
Quality of life primarily focuses on the impact of patients' physical and psychological health, as well as symptoms, and impact for their daily lives. Quality of life will be qualitatively deeply explore by interview, and quantitatively survey using EuroQol Five Dimensions Questionnair (EQ-5D) among patients with idiopathic pulmonary fibrosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 28709421Kreuter M, Swigris J, Pittrow D, Geier S, Klotsche J, Prasse A, Wirtz H, Koschel D, Andreas S, Claussen M, Grohe C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Glaser S, Herth FJF, Welte T, Neurohr C, Schwaiblmair M, Held M, Bahmer T, Frankenberger M, Behr J. Health related quality of life in patients with idiopathic pulmonary fibrosis in clinical practice: insights-IPF registry. Respir Res. 2017 Jul 14;18(1):139. doi: 10.1186/s12931-017-0621-y.
- Derived from this study: PubMed 40803740Chu H, Ding Y, Zhou Y, Ji P, Yuan B, Zhan X, Lu X, Liu N, Zhang Y, Yan B, Fang X, Xu X, Huang Z, Li W, Shen N, Zhan S. Patient journey and Quality of Life for Patients with Idiopathic Pulmonary Fibrosis (IPFLife) in China: a sequential exploratory mixed methods research protocol. BMJ Open. 2025 Aug 12;15(8):e098770. doi: 10.1136/bmjopen-2025-098770.
- Individual participant dataSharing planned: No. This is a deeply exploration study about rare disease in China, which will integrate qualitative and quantitative data to answer the research question. This IPD data could not be shared. If some researchers plan to request IPD data, who could send email to the investigators. the investigators will review the request and send the available data.
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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.
Hongling Chu, PhD principal investigator
Peking University Third Hospital
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 Chu Hongling at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Oct 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 China. 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?
Results are not available in the source record.
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?
Unmet patient needs (time frame: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey). 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 NCT06629623, which also lists 2 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 8 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.