Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis (CHP-HRQOL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04273867|
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : September 22, 2021
|Condition or disease||Intervention/treatment|
|Hypersensitivity Pneumonitis Chronic Hypersensitivity Pneumonitis Interstitial Lung Disease Extrinsic Allergic Alveolitis Health-related Quality of Life||Other: Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis|
|Actual Study Start Date :||July 10, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||February 2022|
|Chronic Hypersensitivity Pneumonitis Patients||
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.
- Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis [ Time Frame: Day 0 ]The newly developed survey that is being validated consists of 42 items that assess the impact that Hypersensitivity Pneumonitis has on daily life for those who have the disease.
- Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis by administering the Short Form (SF-12) Survey [ Time Frame: Day 0 ]This survey will be used to assess the validity of the newly developed health-related quality of life instrument. This survey consists of 12 items. The average score for this survey has been calibrated to 50 with scores below 50 indicating a below average score and scores above 50 indicating an above average score.
- Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis by administering the King's Brief Interstitial Lung Disease Questionnaire [ Time Frame: Day 0 ]This survey will be used to assess the validity of the newly developed health-related quality of life instrument. This survey consists of 15 items and is scored from 0-100 with 100 indicating good health.
- Change in Health-related Quality of Life Assessment Score [ Time Frame: 2 weeks following Day 0 ]The newly developed survey will be administered again in 2 weeks following the first assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273867
|Contact: Kerri Aronson, MDfirstname.lastname@example.org|
|Contact: Laura Pinheiro, PhD, MPHemail@example.com|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: Kerri I Aronson, MD firstname.lastname@example.org|
|Principal Investigator: Kerri Aronson, MD|
|Principal Investigator:||Kerri I Aronson, MD||Weill Medical College of Cornell University|