CompletedNot Applicable

Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis

United States60 participantsStarted 2020-07-10

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 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
. 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.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis

Timeframe: 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

Timeframe: 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

Timeframe: Day 0

Change in Health-related Quality of Life Assessment Score

Timeframe: 2 weeks following Day 0

Trial details

NCT IDNCT04273867

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-02-22

View on ClinicalTrials.gov More Hypersensitivity Pneumonitis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 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
. 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.

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

What they're measuring

Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis

Timeframe: 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

Timeframe: 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

Timeframe: Day 0

Change in Health-related Quality of Life Assessment Score

Timeframe: 2 weeks following Day 0