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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04273867
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and will resume based on guidance of public health authorities. This is not a suspension of IRB approval.)
First Posted : February 18, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Pulmonary Fibrosis Foundation
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief 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).

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

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. Patients will be recruited from WCMC and outside physician referral for the study. Patients will be asked to sign informed consent for participation. At the initial visit patients 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. 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited in many ways including i2b2 search in Electronic Medical Record (EMR) (EPIC) for patients with diagnosis code for Hypersensitivity Pneumonitis, or Extrinsic Allergic Alveolitis (ICD 10: J67.9), weekly review of scheduled office visits in the EMR for patients with diagnosis of Hypersensitivity Pneumonitis, multi-disciplinary conference discussions of patients with a diagnosis of Chronic Hypersensitivity Pneumonitis, physician Referrals from both WCM and local outside institutions, recruitment flyers, and patient support groups
Criteria

Inclusion Criteria:

  • Understand and sign the informed consent document
  • Documented diagnosis of HP made and confirmed at an ILD center via expert consensus or in multidisciplinary discussion
  • Diagnosis based upon a minimum of a medical history, physical examination, pulmonary function testing, and computerized tomography (CT) scan. Pathology will be reviewed if available but is not required.
  • HP must be the primary pulmonary disease
  • Anticipated ability to complete follow up survey within 2 weeks of initial survey completion

Exclusion Criteria:

  • Non-English Speaking (Patient must be able to speak and read English fluently but it does not have to be their primary language)
  • Inability to complete questionnaire due to cognitive impairment

Information from the National Library of Medicine

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


Locations
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United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Pulmonary Fibrosis Foundation
Investigators
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Principal Investigator: Kerri I Aronson, MD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04273867    
Other Study ID Numbers: 19-05020233
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Pneumonia
Alveolitis, Extrinsic Allergic
Hypersensitivity
Respiratory Tract Diseases
Immune System Diseases
Respiratory Tract Infections
Respiratory Hypersensitivity
Hypersensitivity, Immediate