Hypersensitivity PneumonitisCHP-HRQOLNCT04273867
Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis
An observational study of Hypersensitivity Pneumonitis and Chronic Hypersensitivity Pneumonitis, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity Pneumonitis, Chronic Hypersensitivity Pneumonitis, Interstitial Lung Disease
- What is being tested?
- Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2020to 22 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Hypersensitivity Pneumonitis, Chronic Hypersensitivity Pneumonitis, Interstitial Lung Disease, Extrinsic Allergic Alveolitis, Health-related Quality of Life
- Being tested
- Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument
- Medical subject headings
- Alveolitis, Extrinsic Allergic, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey InstrumentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Hypersensitivity Pneumonitis Patients | Not described Receives: Other: Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks following Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start10 Jul 2020
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity PneumonitisStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Pulmonary Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Kerri I Aronson, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273867
- Sponsor's protocol ID
- 19-05020233
- Acronym
- CHP-HRQOL
- Status last verified
- Jul 2023
- First submitted
- 13 Feb 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis
- ClinicalTrials.gov ID
- NCT04273867
- Acronym / sponsor ID
- CHP-HRQOL / 19-05020233
- Conditions
- Hypersensitivity Pneumonitis, Chronic Hypersensitivity Pneumonitis, Interstitial Lung Disease, Extrinsic Allergic Alveolitis, Health-related Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Pulmonary Fibrosis Foundation
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Hypersensitivity Pneumonitis Patients | – | Other: Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey InstrumentThis 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. | Other | Chronic Hypersensitivity Pneumonitis Patients |
Primary outcome
Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis
Time frame: Day 0
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.
Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis by administering the Short Form (SF-12) Survey
Time frame: Day 0
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.
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
Time frame: Day 0
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.
Change in Health-related Quality of Life Assessment Score
Time frame: 2 weeks following Day 0
The newly developed survey will be administered again in 2 weeks following the first assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri I Aronson, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity Pneumonitis and Chronic Hypersensitivity Pneumonitis, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.