Home Monitoring in Idiopathic Pulmonary Fibrosis; Improving Use of Anti-fibrotic Medication and Quality of Life

Study Overview
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Brief Summary
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In this study it will be investigate whether a home monitoring program improves disease-specific health-related quality of life (HRQOL) for patients with idiopathic pulmonary fibrosis (IPF) through appropriate medication use and subsequently results in better objective and subjective outcomes.

Detailed Description
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IPF is a chronic disease with progressive scarring of the lung tissue (fibrosis), resulting in a poor prognosis and a devastating impact on the lives of patients and their families. Progressive shortness of breath, cough and fatigue are major factors influencing health-related quality of life (HRQOL) in patients with IPF. Recently two anti-fibrotic drugs became available that slow down disease progression. The availability of effective drugs for this devastating disease has importantly changed daily care and research in IPF. Currently, one of the major challenges in daily IPF care is the evaluation of how individual patients objectively and subjectively experience treatment and benefit from treatment. The use of information communication technology in health care, also named e-health, is a promising solution to improve the quality of care. E-health allows remote exchange of data between patients and health care professionals which enables monitoring, research and management of long term conditions. Also communication between patients and physicians, and physicians mutually, becomes more accessible. This creates an opportunity for earlier intervention by health care professionals, which may prevent a hospital admission. This might improve quality of life and reduce costs. Patients easily get access to up-to-date and tailored information, in an interactive way. By providing these tools, patients may better understand their health conditions and become actively involved in management of their own health care, which may lead to a better health status. An 'internet tool' for patients with IPF have been developed, providing information and enabling them to keep track of their own symptoms, HRQOL scores, medication use and lung function results. In this study it will be investigated whether a home monitoring program improves disease-specific HRQOL for IPF patients through appropriate medication use and subsequently results in better objective and subjective outcomes.

Official Title
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Home Monitoring in Idiopathic Pulmonary Fibrosis; Improving Use of Anti-fibrotic Medication and Quality of Life

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Other: Home monitoring program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with a diagnosis of IPF according to the ATS 2011 criteria and about to start on anti-fibrotic treatment (either nintedanib or pirfenidone) Exclusion Criteria: Not able to speak, read or write in Dutch No access to internet

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective randomized clinical multi-center study to evaluate the effect of home monitoring on disease-specific HRQOL, (appropriate) medication use and other patient-relevant outcomes in patients with IPF treated with anti-fibrotic drugs. Patients with IPF about to start on anti-fibrotic medication will be randomly assigned to receive either the home monitoring program integrated with standard care or standard care alone after informed consent. Patient will be stratified for study center and medication.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group will receive standard care alone. | |
| Experimental: Home monitoring group<br>Intervention will consist of a home monitoring program added to standard care. | Other: Home monitoring program<br>* The home monitoring program consists of 1) the use of an interactive internet tool to coach patients and enhance self-management 2) home-based pulmonary function testing with a handheld spirometer and 3) recording of patient-reported outcomes (PROs).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the change in total score of King's brief Interstitial Lung Disease Health Status (K-BILD) questionnaire between the home monitoring group and the standard care group | Change in HRQOL assessed by the K-BILD, between control group and home monitoring group at the end of the study. The K-BILD is a 15-item self-administered questionnaire on a 7-point response scale. It has three domains: breathlessness and activities, psychological and chest symptoms.The domain and total score ranges are 0-100, with the higher scores corresponding with better HRQL. | 24 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the change in total score of King's brief Interstitial Lung Disease Health Status (K-BILD) questionnaire between the home monitoring group and the standard care group | Change in HRQOL assessed by the K-BILD, between control group and home monitoring group. The K-BILD is a 15-item self-administered questionnaire on a 7-point response scale. It has three domains: breathlessness and activities, psychological and chest symptoms.The domain and total score ranges are 0-100, with the higher scores corresponding with better HRQL. | 12 weeks after inclusion | 
| Patient-reported outcome (PRO) scores (GRC) | Patients will fill in the Global Rating of Change (GRC) which measures whether QoL has improved or deteriorated over a certain period of time, with scores range from -7 to +7, with positive scores corresponding with improvement in QoL | 12 weeks after inclusion | 
| Patient-reported outcome (PRO) scores (EQ5D) | Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL. | 12 weeks after inclusion | 
| Patient-reported outcome (PRO) scores (HADS) | Patients will complete the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire with 7 questions in the domain anxiety and 7 questions in the domain depression on a 0-3 Likert scale. Higher values represent higher anxiety and depression levels, with a maximum of 21 point in both domains. There is a cut-off score of 8/21 for anxiety and depression. | 12 weeks after inclusion | 
| Patient-reported outcome (PRO) scores (HADS) | Patients will complete the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire with 7 questions in the domain anxiety and 7 questions in the domain depression on a 0-3 Likert scale. Higher values represent higher anxiety and depression levels, with a maximum of 21 point in both domains. There is a cut-off score of 8/21 for anxiety and depression. | 24 weeks after inclusion | 
| Patient-reported outcome (PRO) scores (EQ5D) | Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL. | 24 weeks after inclusion | 
| Patient-reported outcome (PRO) scores (GRC) | Patients will complete the Global Rating of Change (GRC) which measures whether QoL has improved or deteriorated over a certain period of time, with scores range from -7 to +7, with positive scores corresponding with improvement in QoL. | 24 weeks after inclusion | 
| Patient expectations and satisfaction with medication (PESaM scores) | Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes. | Baseline and 12 weeks after inclusion | 
| Patient expectations and satisfaction with medication (PESaM scores) | Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 24 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes. | Baseline and 24 weeks after inclusion | 
| Patient satisfaction with medication (PESaM scores) | Overall patient satisfaction with medication after 24 weeks resulting from the 26-item PESaM questionnaire. For each question it is different whether a higher score represents better or worse outcomes | 24 weeks after inclusion | 
| Patient satisfaction with the care process | Evaluation and satisfaction questionnaire at the end of the study. 10-item questionnaire with answers on a scale from -5 to 5, with higher scores corresponding with higher satisfaction | 24 weeks after inclusion | 
| Number of patients who discontinue use of medication, pills used and pills wasted | Every week patients register whether they missed pills (and the amount of pills wasted). Discontinuation or switch of medication is registered both by patients and researchers. | 24 weeks after inclusion | 
| Amount of contacts with healthcare providers and number of visits per patient | During the study patients register their contacts with healthcare providers (hospital visits, general practitioner visits, physiotherapist, dietician, psychologist), after 24 weeks the amount of contacts will be assessed | 24 weeks after inclusion | 
| FVC decline | FVC decline measured by hospital-based spirometry and daily home spirometry | 12 weeks after inclusion | 
| FVC decline | FVC decline measured by hospital-based spirometry and daily home spirometry | 24 weeks after inclusion | 
| Personal goal of patient defined at start of study | Change in score of personal goal. Patients define a personal goal at the start of the study and they score on a scale from 0 -10 how far they have reached their goal | 24 weeks after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, eHealth, patient-reported outcomes, home spirometry, cost-effectiveness, home monitoring