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RESEARCH QUESTION

Does home monitoring improve appropriate use of anti-fibrotic medication and health related quality of life (HRQOL) for patients with idiopathic pulmonary fibrosis (IPF)?

HYPOTHESIS

We hypothesize that the home monitoring program will improve disease-specific HRQOL through appropriate medication use, and will result in better objective and subjective outcomes for patients with IPF at lower costs.

STUDY DESIGN

Prospective randomized controlled multi-centre study

STUDY POPULATION

All patients with a diagnosis of IPF according to the ATS 2011 criteria and about to start on anti-fibrotic treatment are eligible.

INTERVENTION

The intervention is a home monitoring program, consisting of an internet tool to coach patients, home based hand-held spirometry and recording of patient reported outcome measures (PROMs), with direct feedback to patient and treating physician. Home monitoring added to standard care will be compared with standard care alone.

OUTCOME MEASURES

The primary outcome is the change in total score of the Kings Brief Interstitial Lung Disease questionnaire at 24 weeks. Secondary outcome measures are patient experiences and satisfaction with medication; number of pills used and wasted; number of discontinuations of medication; different PROMs; costs and cost-effectiveness; number of contacts with healthcare providers; lung function decline at 24 weeks.

SAMPLE SIZE/DATA ANALYSIS

Based on earlier studies and own experience, we estimate that with 72 patients, the study will have 80% power to detect a significant between-group difference in the change in total K-BILD score from baseline to week 24. We will include 90 patients to allow for 20% dropout. Descriptive statistics will be used to estimate frequencies, means, and standard deviations of study variables. To examine the effect of home monitoring on HRQOL and pulmonary function, Student’s t-tests and linear mixed modelling will be used to compare the home monitoring and standard care group.

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