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

Study 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.

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

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with IPF<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | Change in St. George's Respiratory Questionnaire | Baseline, 6 months, 12 months, 24 months, 36 months | 
| Health-related quality of life | Change in St. George's Respiratory Questionnaire, IPF-specific | 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 | Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months | 
| Number and type of comorbidities | Prevalence of comorbidities at baseline | Baseline | 
| Number and type of comorbidities | Incidence of new comorbidities after 6 months, 12 months, 24 months and 36 months | Change/incidence at 6 months, 12 months, 24 months and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function tests | Change in forced vital capacity | Baseline, 6 months, 12 months, 24 months, 36 months | 
| Lung function tests | Change in diffusion capacity for carbon monoxide | Baseline, 6 months, 12 months, 24 months, 36 months | 
| 6-minute walk test | Change in 6-minute walk test | Baseline, 6 months, 12 months, 24 months, 36 months | 
| Progression in serum/plasma biomarker levels | Increase or decrease in serum/plasma biomarker levels | Baseline, 6 months, 12 months, 24 months, 36 months | 
| Health-related quality of life | Change in Short Form 36 | 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 | Baseline, 6 months, 12 months, 24 months, 36 months | 
| Disease progression | Change in interstitial changes on high resolution CT-scan (HRCT) | Baseline, 12 months, 24 months, 36 months | 
| Disease progression | Changes in number of acute exacerbations | Baseline, 6 months, 12 months, 24 months, 36 months | 
| Disease progression | Changes in use of supplementary oxygen | Baseline, 6 months, 12 months, 24 months, 36 months |