Quality of Life in IPF - Patient and Physician Perceptions

NCT04148157 | Completed

• 1 other identifier: STUDY00008283
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Quality of Life; Questionnaire

Outcome Measures

Primary Outcomes (3)

• Patient and Physician Responses to the Kings Brief ILD (K-BILD) Questionnaire

  A comparison of physician and patient reported quality of life based on responses to the Kings Brief ILD Questionnaire (K-BILD). The domain and total score ranges are 0-100 where a score of 100 represents best health status.

  6 months

• Patient and Physician Responses to the EuroQol five dimensional 5-Level (EQ-5D-5L) questionnaire

  A comparison of physician and patient reported quality of life based on responses to the EuroQol five dimensional 5-Level (EQ-5D-5L) questionnaire. The domain ranges are 1-5 and the total score ranges are 5-25 where a score of 5 represents best health status. The visual analog scale portion of the questionnaire ranges from 0 to 100 where a score of 100 represents best health status.

  6 months

• Patient and Physician Responses to the Raghu Quality of Life in Interstitial Lung Disease (RQ-LIFE-ILD) Questionnaire

  A comparison of physician and patient reported quality of life based on responses to a novel visual analog scale questionnaire the Raghu Quality of Life in Interstitial Lung Disease (RQ-LIFE-ILD) Questionnaire. The domain ranges are 0 to 10 and the total score ranges are 0 to 50 where a score of 0 represents best health status.

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants in this study will hold a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) as detailed above. As IPF occurs only in adults all subjects must be 18 years of age or older. Both men and women will be recruited for the study. Subjects of all ethnicities and racial minorities will be recruited. Physicians who are seeing these patients for regular clinical visits during the study will also be included.

You may qualify if:

• Patients with a multidisciplinary diagnosis of IPF according to the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guidelines.
• All ranges of disease severity based on pulmonary function testing: forced vital capacity (FVC) and diffusing capacity (DLCO).

You may not qualify if:

• Any impairment or co-morbid disease that results in an inability to read or understand a questionnaire or provide informed consent. The study team member will make this determination according to their best clinical judgement.
• The questionnaires will be administered in English language only and thus this study will be conducted in patients who are able to read, write, and speak English language.

Sponsors & Collaborators

• University of Washington: lead
• Washington Research Foundation: collaborator

Study Sites (1)

University of Washington - Center for Interstitial Lung Disease

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Scallan C, Strand L, Hayes J, Kadura S, Collins B, Ho L, Spada C, Canestaro W, Kolb M, Raghu G. R-scale for pulmonary fibrosis: a simple, visual tool for the assessment of health-related quality of life. Eur Respir J. 2022 Jan 13;59(1):2100917. doi: 10.1183/13993003.00917-2021. Print 2022 Jan.

  PMID: 34112729 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ganesh Raghu, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 1, 2019
• Study Start: September 23, 2019
• Primary Completion: November 27, 2019
• Study Completion: December 1, 2020
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)