Clinical trial NCT06629623: Current Status of Diagnosis, Treatment and Quality of Life for Patients with Idiopathic Pulmonary Fibrosis
Official title: Current Status of Diagnosis, Treatment and Quality of Life for Patients with Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic pulmonary fibrosis
rare disease
quality of life
mixed methods
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Beijing Chao Yang Hospital
name: Zhejiang Chinese Medical University
name: West China Hospital
name: Peking University Shenzhen Hospital
First posted: 2024-10-08
Enrollment: 310
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

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.

Primary outcomes:
measure: Unmet patient needs
timeFrame: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey
measure: Patient journey
timeFrame: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey.
measure: Quality of life
timeFrame: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hongling Chu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.