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Enrolling by invitation NCT06629623

Current Status of Diagnosis, Treatment and Quality of Life for Patients with Idiopathic Pulmonary Fibrosis

Observational Idiopathic Pulmonary Fibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Idiopathic Pulmonary Fibrosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • Unmet patient needs [Time frame: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey]
  • Patient journey [Time frame: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey.]
  • Quality of life [Time frame: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey]

Eligibility criteria

Inclusion criteria

  • IPF patients who are diagnosed according to international guidelines.
  • Physicians who are clinical experts with extensive experience in the treatment of IPF.

Exclusion criteria

\- The patient is unable to express his/her opinion clearly.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

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. Res PMID 28709421
  • Chu 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. PMID 40803740

Identifiers

NCT: NCT06629623 · M2024203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗