跳至主要内容
临床试验/NCT02818712
NCT02818712已完成不适用

Health-related Quality of Life and Comorbidities in Danish Patients With Idiopathic Pulmonary Fibrosis - a Nationwide Follow-up

Aarhus University Hospital3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
3
主要终点
Health-related quality of life

研究概览

简要总结

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with a high mortality. Health-related quality of life (HRQL) is impaired in patients with IPF. Little is known about the properties of recently developed HRQL questionnaires and about the longitudinal changes in HRQL, including factors with an impact on HRQL. Comorbidities have an impact on patients with IPF, but reports differ in incidence and prevalence. The impact of comorbidities on HRQL and disease progression has only been studied sparsely. Also, the association between biomarkers and disease progression need to be examined further.

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

  • A clinical diagnosis of IPF
  • Signed informed consent

排除标准

  • Clinical, radiological or histological findings inconsistent with a diagnosis of IPF
  • Inability or unwillingness to adhere to the study
  • Active on lung transplantation list

结局指标

主要结局

Health-related quality of life

时间窗: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months

Changes in King's Brief Interstitial Lung Disease questionnaire

Number and type of comorbidities

时间窗: Change/incidence at 6 months, 12 months, 24 months and 36 months

Incidence of new comorbidities after 6 months, 12 months, 24 months and 36 months

次要结局

  • Lung function tests(Baseline, 6 months, 12 months, 24 months, 36 months)
  • Disease progression(Baseline, 6 months, 12 months, 24 months, 36 months)
  • 6-minute walk test(Baseline, 6 months, 12 months, 24 months, 36 months)
  • Progression in serum/plasma biomarker levels(Baseline, 6 months, 12 months, 24 months, 36 months)
  • Health-related quality of life(Baseline, 6 months, 12 months, 24 months, 36 months)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验