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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02818712
Enrollment
150
Registered
2016-06-30
Start date
2016-08-31
Completion date
2021-06-30
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

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.

Interventions

None listed

Sponsors

University Hospital, Gentofte, Copenhagen
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
Aarhus University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number and type of comorbiditiesBaselinePrevalence of comorbidities at baseline
Health-related quality of lifeBaseline, 6 months, 12 months, 24 months, 36 monthsChange in St. George's Respiratory Questionnaire

Secondary

MeasureTime frameDescription
Progression in serum/plasma biomarker levelsBaseline, 6 months, 12 months, 24 months, 36 monthsIncrease or decrease in serum/plasma biomarker levels
Lung function testsBaseline, 6 months, 12 months, 24 months, 36 monthsChange in forced vital capacity
Disease progressionBaseline, 12 months, 24 months, 36 monthsChange in interstitial changes on high resolution CT-scan (HRCT)
Health-related quality of lifeBaseline, 6 months, 12 months, 24 months, 36 monthsChange in Short Form 36
6-minute walk testBaseline, 6 months, 12 months, 24 months, 36 monthsChange in 6-minute walk test

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026