Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study
NCT ID: NCT03979430
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2018-09-07
2020-12-31
Brief Summary
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Detailed Description
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All patients will receive a tablet and a spirometer for daily home spirometry. Each patient is supposed to do the home spirometry at the same time every morning. The spirometer and the tablet are connected via Bluetooth and data will be transferred to a webpage after the measurement, that team members have access to the data and can see the progress daily. Alerts will be automatically send to team members, if the FVC-value decreases about 5% or more within three consecutive days or if the patient does not do the measurement on three consecutive days. Study period is one year.
In addition to the home spirometry, patients will conduct a survey to measure health related quality of life (K-BILD). This questionnaire will be conducted at baseline and then every 12 weeks. Every 4 weeks the patients are participating in a phone interview to record changes in medication and condition. At baseline and after 3, 6, 9, and 12 months, patients will conduct a 6 minutes walking test, lung function test, blood will be drawn for biomarker analysis, and sputum, nasal swab, and a urine sample will be collected and analyzed.
Aim is to detect and treat an acute exacerbation early.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Intervention
There is only one arm with the intervention.
Home spirometry
Patients will receive a tablet and a spirometer for daily home spirometry. Each patient is supposed to do the home spirometry at the same time every morning. The spirometer and the tablet are connected via Bluetooth. Data will be transferred to a webpage, which team members have access to. Alerts will be automatically send to team members, if the FVC-value decreases about 5% or more within three consecutive days or if the patient does not do the measurement on three consecutive days. Study period is one year. Patients will also conduct a survey to measure health related quality of life (K-BILD). This questionnaire, as well as a phone interview to record changes in medication and condition will be conducted at baseline and every 4 weeks. At baseline and after 3, 6, 9, and 12 months, patients will conduct a 6 minutes walking test, lung function test, blood will be drawn for biomarker analysis, and sputum, nasal swab, and urine samples will be collected and analyzed.
Interventions
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Home spirometry
Patients will receive a tablet and a spirometer for daily home spirometry. Each patient is supposed to do the home spirometry at the same time every morning. The spirometer and the tablet are connected via Bluetooth. Data will be transferred to a webpage, which team members have access to. Alerts will be automatically send to team members, if the FVC-value decreases about 5% or more within three consecutive days or if the patient does not do the measurement on three consecutive days. Study period is one year. Patients will also conduct a survey to measure health related quality of life (K-BILD). This questionnaire, as well as a phone interview to record changes in medication and condition will be conducted at baseline and every 4 weeks. At baseline and after 3, 6, 9, and 12 months, patients will conduct a 6 minutes walking test, lung function test, blood will be drawn for biomarker analysis, and sputum, nasal swab, and urine samples will be collected and analyzed.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of IPF
* Age \> 18 years
* FVC \< 70%
* DLCO-SB \<60%
* Ability to work with a tablet and home spirometer
Exclusion Criteria
* Patient cannot participate in study related processes
* pulmonary infection within the last 4 weeks
* acute exacerbation within the last 4 weeks
* obstructive Ventilation disorders
* other respiratory decline within the last 4 weeks
* relevant malignancy within the last 5 years
18 Years
85 Years
ALL
No
Sponsors
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University of Giessen
OTHER
Hannover Medical School
OTHER
Ludwig-Maximilians - University of Munich
OTHER
LungenClinic Grosshansdorf
OTHER
Heidelberg University
OTHER
Responsible Party
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Michael Kreuter
Principal Investigator
Principal Investigators
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Michael Kreuter, Prof.
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Locations
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University of Gießen-Marburg
Giessen, , Germany
LungenClinic Grosshansdorf
Großhansdorf, , Germany
Medical University Hannover
Hanover, , Germany
CPC Comprehensive Pneumology Center
München, , Germany
Countries
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Other Identifiers
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AE-IPF study
Identifier Type: -
Identifier Source: org_study_id