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Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04273867
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Weill Medical College of Cornell University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kerri I Aronson, MD
Principal Investigator Affiliation Weill Medical College of Cornell University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypersensitivity Pneumonitis, Chronic Hypersensitivity Pneumonitis, Interstitial Lung Disease, Extrinsic Allergic Alveolitis, Health-related Quality of Life
Additional Details

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.

Arms & Interventions

Arms

: Chronic Hypersensitivity Pneumonitis Patients

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10065

Site Contact

Kerri I Aronson, MD

kia9010@med.cornell.edu

646-962-2733