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临床试验/NCT04273867
NCT04273867已完成不适用

Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
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

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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.

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

时间窗: 2 weeks following Day 0

The newly developed survey will be administered again in 2 weeks following the first assessment.

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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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