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

NCT06629623 | Enrolling By Invitation DMC

• 1 other identifier: M2024203
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic pulmonary fibrosis; rare disease; quality of life; mixed methods

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey

Study Arms (1)

Patients with IPF

Other: No intervention

Interventions

No intervention OTHER

No intervention

Patients with IPF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chu Hongling: lead
• Boehringer Ingelheim: collaborator
• Beijing Chao Yang Hospital: collaborator
• Zhejiang Chinese Medical University: collaborator
• West China Hospital: collaborator
• Peking University Shenzhen Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (2)

• 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.

  PMID: 28709421 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Rare Diseases

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongling Chu, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 8, 2024
• Study Start: July 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)