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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 310

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with IPF	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chu Hongling
• Collaborators: Boehringer Ingelheim; West China Hospital; Peking University Shenzhen Hospital; Zhejiang Chinese Medical University; Affiliated Beijing Chaoyang Hospital of Capital Medical University
• Investigators: Principal Investigator: Hongling Chu, PhD, Peking University Third Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; rare disease; Idiopathic pulmonary fibrosis; mixed methods
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: M2024203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No