Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis (CHP-HRQOL)

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).

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Disease; Hypersensitivity Pneumonitis; Extrinsic Allergic Alveolitis; Health-related Quality of Life; Chronic Hypersensitivity Pneumonitis
• Intervention / Treatment: 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. 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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

• Study Contact: Name: Kerri Aronson, MD; Phone Number: 646-962-2733; Email: kia9010@med.cornell.edu
• Study Contact Backup: Name: Laura Pinheiro, PhD, MPH; Phone Number: 646-962-5898; Email: lcp2003@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis	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.	Day 0
Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis by administering the Short Form (SF-12) Survey	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.	Day 0
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	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.	Day 0
Change in Health-related Quality of Life Assessment Score	The newly developed survey will be administered again in 2 weeks following the first assessment.	2 weeks following Day 0

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Pulmonary Fibrosis Foundation
• Investigators: Principal Investigator: Kerri I Aronson, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): February 22, 2023
• Study Completion (Actual): February 22, 2023

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Respiratory Hypersensitivity; Hypersensitivity; Lung Diseases; Pneumonia; Lung Diseases, Interstitial; Alveolitis, Extrinsic Allergic
• Other Study ID Numbers: 19-05020233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No