Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis

NCT04273867 | Completed

• 1 other identifier: 19-05020233
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Chronic Hypersensitivity Pneumonitis Patients

Other: Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument

Interventions

Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument OTHER

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.

Chronic Hypersensitivity Pneumonitis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• years old or older
• 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
• 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.
• HP must be the primary pulmonary disease
• Anticipated ability to complete follow up survey within 2 weeks of initial survey completion
• Participants recruited from the PFF registry must have agreed to be contacted for ancillary research studies.

You may not qualify if:

• 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
• Patients who have not been seen by or communicated with their provider in over 2 years

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Pulmonary Fibrosis Foundation: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kerri I Aronson, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 18, 2020
• Study Start: July 10, 2020
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)