NCT04273867

Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to administer and validate a disease specific health related quality of life (HRQOL) survey for patients with Chronic Hypersensitivity Pneumonitis (CHP).

Detailed description

The objective of this study is to administer and validate a disease-specific health related quality of life (HRQOL) survey for patients with Chronic Hypersensitivity Pneumonitis (CHP). The survey items have been developed and revised from prior qualitative research with CHP patients. Potential participants will be recruited from WCMC, the Pulmonary Fibrosis Foundation (PFF) Registry and outside physician referral for the study. Participants will be asked to sign informed consent. At the initial visit participants will be asked to complete the survey and two additional PROs needed for concurrent validity testing. Participants will then be asked to complete the HRQOL survey under study a second time 2 weeks after the initial visit for test-re-test reliability testing. Pulmonary function testing and six minute walk test results will be collected. Pertinent demographic and clinical information will be collected from the patients and their medical records or registry data (if a PFF Registry participant). All information will be entered into a REDCap database for secure data management and storage. Psychometric testing will be performed on the overall survey instrument and the individual items in order to test validity and reliability. The goal is that the survey developed will be a reliable and valid measurement tool for use in both clinical practice and research settings.

Conditions

• Hypersensitivity Pneumonitis
• Chronic Hypersensitivity Pneumonitis
• Interstitial Lung Disease
• Extrinsic Allergic Alveolitis
• Health-related Quality of Life

Interventions

Type	Name	Description
OTHER	Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument	This survey has been developed and revised from prior qualitative research with CHP patients and will be used to better evaluate disease status and quality of life with CHP.

Timeline

• Start date: 2020-07-10
• Primary completion: 2023-02-22
• Completion: 2023-02-22
• First posted: 2020-02-18
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States