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Clinical Trials/NCT02818712
NCT02818712
Completed
Not Applicable

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

Aarhus University Hospital3 sites in 1 country150 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Pulmonary Fibrosis
Sponsor
Aarhus University Hospital
Enrollment
150
Locations
3
Primary Endpoint
Health-related quality of life
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
June 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aarhus University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A clinical diagnosis of IPF
  • Signed informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

Health-related quality of life

Time Frame: 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

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (3)

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