Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT04148157
Brief Summary:
This study aims to evaluate the differences between patient's and their physicians' perception of quality of life and the effect of disease severity and co-morbidities. Patients and physicians will complete two sets of questionnaires at an initial clinic visit and again six months later.
Detailed Description:
Idiopathic Pulmonary Fibrosis is a progressive and debilitating disease characterized by progressive scarring of the lung parenchyma of unknown cause. In the US approximately 100,000 individuals have been diagnosed with this disease and the only cure available is lung transplantation. There have been two drugs approved by the FDA for treatment of IPF which have demonstrated the ability to slow disease progression but have no impact on quality of life.
Symptoms of IPF include shortness of breath, cough, and fatigue which all contribute to a decreased quality of life. Additionally, these symptoms and the need for supplemental oxygen use causes significant psychological and social impairment. Multiple questionnaires have been used to measure patient reported quality of life in both clinical and research settings. The King's Brief Interstitial Lung Disease (KBILD) Questionnaire is a disease-specific patient reported outcome measure and has been validated across several different patient groups and countries. Additionally, the EuroQol group has developed the EuroQol five dimensional 5-Level (EQ-5D-5L) questionnaire which is a non-disease specific assessment of health-related quality of life and has not yet been widely used in a population of patients with IPF.
Significant disparity between patient and physician perception of quality of life has been demonstrated across different disease processes. While there are many contributing factors to overall wellbeing the general assumption is that with more advanced disease quality of life predictably decreases. The investigators plan to test this hypothesis to better understand the complex relationship between chronic disease and quality of life in patients with IPF.
Study:
NCT04148157
Study Brief:
Protocol Section:
NCT04148157