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

Aarhus University Hospital150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Idiopathic Pulmonary Fibrosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. A clinical diagnosis of IPF 2. Signed informed consent Exclusion Criteria: 1. Clinical, radiological or histological findings inconsistent with a diagnosis of IPF 2. Inability or unwillingness to adhere to the study 3. Active on lung transplantation list

Locations (3)

Aarhus University Hosptial

Aarhus C, Denmark

Outcomes

Primary Outcomes

Health-related quality of life

Change in St. George's Respiratory Questionnaire

Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

Health-related quality of life

Change in St. George's Respiratory Questionnaire, IPF-specific

Time frame: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months

Health-related quality of life

Changes in King's Brief Interstitial Lung Disease questionnaire

Time frame: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months

Number and type of comorbidities

Prevalence of comorbidities at baseline

Time frame: Baseline

Number and type of comorbidities

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

Time frame: Change/incidence at 6 months, 12 months, 24 months and 36 months

Secondary Outcomes

Lung function tests

Change in forced vital capacity

Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

Lung function tests

Change in diffusion capacity for carbon monoxide

Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

6-minute walk test

Change in 6-minute walk test

Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

Progression in serum/plasma biomarker levels

Increase or decrease in serum/plasma biomarker levels

Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

Health-related quality of life

Change in Short Form 36

Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

Health-related quality of life

Changes in University of California San Diego Shortness Of Breath Questionnaire

Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

Disease progression

Change in interstitial changes on high resolution CT-scan (HRCT)

Time frame: Baseline, 12 months, 24 months, 36 months

Disease progression

Changes in number of acute exacerbations

Time frame: Baseline, 6 months, 12 months, 24 months, 36 months

Disease progression

Changes in use of supplementary oxygen

Time frame: Baseline, 6 months, 12 months, 24 months, 36 months