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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818712
• Other study ID #: IPF: HRQL, comorb and biomark
• Status: Completed
• Start date: August 2016
• Est. completion date: June 2021

Study information

• Verified date: November 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Denmark	Aarhus University Hosptial	Aarhus C
Denmark	Gentofte Hospital	Hellerup
Denmark	Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital	Copenhagen University Hospital, Gentofte, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life	Change in St. George's Respiratory Questionnaire	Baseline, 6 months, 12 months, 24 months, 36 months
Primary	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
Primary	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
Primary	Number and type of comorbidities	Prevalence of comorbidities at baseline	Baseline
Primary	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	Lung function tests	Change in forced vital capacity	Baseline, 6 months, 12 months, 24 months, 36 months
Secondary	Lung function tests	Change in diffusion capacity for carbon monoxide	Baseline, 6 months, 12 months, 24 months, 36 months
Secondary	6-minute walk test	Change in 6-minute walk test	Baseline, 6 months, 12 months, 24 months, 36 months
Secondary	Progression in serum/plasma biomarker levels	Increase or decrease in serum/plasma biomarker levels	Baseline, 6 months, 12 months, 24 months, 36 months
Secondary	Health-related quality of life	Change in Short Form 36	Baseline, 6 months, 12 months, 24 months, 36 months
Secondary	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
Secondary	Disease progression	Change in interstitial changes on high resolution CT-scan (HRCT)	Baseline, 12 months, 24 months, 36 months
Secondary	Disease progression	Changes in number of acute exacerbations	Baseline, 6 months, 12 months, 24 months, 36 months
Secondary	Disease progression	Changes in use of supplementary oxygen	Baseline, 6 months, 12 months, 24 months, 36 months