Clinical trial NCT02818712: Health-related Quality of Life and Comorbidities in Danish Patients With Idiopathic Pulmonary Fibrosis - a Nationwide Follow-up
Official title: Health-related Quality of Life and Comorbidities in Danish Patients With Idiopathic Pulmonary Fibrosis - a Nationwide Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Gentofte
name: Odense University Hospital
First posted: 2016-06-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Incident and prevalent patients with IPF in Denmark.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health-related quality of life
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
measure: Health-related quality of life
timeFrame: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months
measure: Health-related quality of life
timeFrame: Baseline, 2 weeks, 6 months, 12 months, 24 months, 36 months
measure: Number and type of comorbidities
timeFrame: Baseline
measure: Number and type of comorbidities
timeFrame: Change/incidence at 6 months, 12 months, 24 months and 36 months
Secondary outcomes:
measure: Lung function tests
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
measure: Lung function tests
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
measure: 6-minute walk test
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
measure: Progression in serum/plasma biomarker levels
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
measure: Health-related quality of life
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
measure: Health-related quality of life
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
measure: Disease progression
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Disease progression
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
measure: Disease progression
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hosptial
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
citation: Prior TS, Hoyer N, Hilberg O, Shaker SB, Davidsen JR, Bendstrup E. Responsiveness and minimal clinically important difference of SGRQ-I and K-BILD in idiopathic pulmonary fibrosis. Respir Res. 2020 Apr 21;21(1):91. doi: 10.1186/s12931-020-01359-3.
citation: Prior TS, Hilberg O, Shaker SB, Davidsen JR, Hoyer N, Birring SS, Bendstrup E. Validation of the King's Brief Interstitial Lung Disease questionnaire in Idiopathic Pulmonary Fibrosis. BMC Pulm Med. 2019 Dec 19;19(1):255. doi: 10.1186/s12890-019-1018-0.
citation: Prior TS, Hoyer N, Shaker SB, Davidsen JR, Yorke J, Hilberg O, Bendstrup E. Validation of the IPF-specific version of St. George's Respiratory Questionnaire. Respir Res. 2019 Aug 28;20(1):199. doi: 10.1186/s12931-019-1169-9.