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

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 Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark
    • Aarhus University Hosptial
  • Hellerup, Denmark
    • Gentofte Hospital
  • Odense, Denmark
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Incident and prevalent patients with IPF in Denmark.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with IPF

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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Odense University Hospital; Copenhagen University Hospital, Gentofte

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: IPF: HRQL, comorb and biomark

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED