Clinical trial NCT04273867: Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis
Official title: Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersensitivity Pneumonitis
Chronic Hypersensitivity Pneumonitis
Interstitial Lung Disease
Extrinsic Allergic Alveolitis
Health-related Quality of Life
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Pulmonary Fibrosis Foundation
First posted: 2020-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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.

Eligibility criteria: Inclusion Criteria:

1. 18 years old or older
2. Understand and sign the informed consent document
3. Documented diagnosis of HP made and confirmed at an ILD center via expert consensus or in multidisciplinary discussion

   a. 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.
4. HP must be the primary pulmonary disease
5. Anticipated ability to complete follow up survey within 2 weeks of initial survey completion
6. Participants recruited from the PFF registry must have agreed to be contacted for ancillary research studies.

Exclusion Criteria:

1. Non-English Speaking (Patient must be able to speak and read English fluently but it does not have to be their primary language)
2. Inability to complete questionnaire due to cognitive impairment
3. Patients who have not been seen by or communicated with their provider in over 2 years

Primary outcomes:
measure: Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis
timeFrame: Day 0
measure: Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis by administering the Short Form (SF-12) Survey
timeFrame: Day 0
measure: 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
timeFrame: Day 0
measure: Change in Health-related Quality of Life Assessment Score
timeFrame: 2 weeks following Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Kerri I Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References: