Clinical trial NCT03420235: Home Monitoring in Idiopathic Pulmonary Fibrosis; Improving Use of Anti-fibrotic Medication and Quality of Life
Official title: Home Monitoring in Idiopathic Pulmonary Fibrosis; Improving Use of Anti-fibrotic Medication and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: quality of life
eHealth
patient-reported outcomes
home spirometry
cost-effectiveness
home monitoring
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: OLVG
name: St. Antonius Hospital
name: Zuyderland Medical Centre
First posted: 2018-02-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 24 weeks after inclusion
Secondary outcomes:
measure: 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
timeFrame: 12 weeks after inclusion
measure: Patient-reported outcome (PRO) scores (GRC)
timeFrame: 12 weeks after inclusion
measure: Patient-reported outcome (PRO) scores (EQ5D)
timeFrame: 12 weeks after inclusion
measure: Patient-reported outcome (PRO) scores (HADS)
timeFrame: 12 weeks after inclusion
measure: Patient-reported outcome (PRO) scores (HADS)
timeFrame: 24 weeks after inclusion
measure: Patient-reported outcome (PRO) scores (EQ5D)
timeFrame: 24 weeks after inclusion
measure: Patient-reported outcome (PRO) scores (GRC)
timeFrame: 24 weeks after inclusion
measure: Patient expectations and satisfaction with medication (PESaM scores)
timeFrame: Baseline and 12 weeks after inclusion
measure: Patient expectations and satisfaction with medication (PESaM scores)
timeFrame: Baseline and 24 weeks after inclusion
measure: Patient satisfaction with medication (PESaM scores)
timeFrame: 24 weeks after inclusion
measure: Patient satisfaction with the care process
timeFrame: 24 weeks after inclusion
measure: Number of patients who discontinue use of medication, pills used and pills wasted
timeFrame: 24 weeks after inclusion
measure: Amount of contacts with healthcare providers and number of visits per patient
timeFrame: 24 weeks after inclusion
measure: FVC decline
timeFrame: 12 weeks after inclusion
measure: FVC decline
timeFrame: 24 weeks after inclusion
measure: Personal goal of patient defined at start of study
timeFrame: 24 weeks after inclusion
Other outcomes:
measure: Home monitoring values of FVC compared to in hospital values of lung function
timeFrame: 12 weeks after inclusion
measure: Home monitoring values of FVC compared to in hospital values of lung function
timeFrame: 24 weeks after inclusion
measure: Correlation between FVC measurements and K-BILD
timeFrame: 12 weeks after inclusion
measure: Correlation between FVC measurements and K-BILD
timeFrame: 24 weeks after inclusion
measure: Correlation between FVC measurements and EQ5D
timeFrame: 12 weeks after inclusion
measure: Correlation between FVC measurements and EQ5D
timeFrame: 24 weeks after inclusion
measure: Correlation between FVC measurements and HADS
timeFrame: 12 weeks after inclusion
measure: Correlation between FVC measurements and HADS
timeFrame: 24 weeks after inclusion
measure: Correlation between FVC measurements and GRC
timeFrame: 12 weeks after inclusion
measure: Correlation between FVC measurements and GRC
timeFrame: 24 weeks after inclusion
measure: Correlation between VAS score on stability of IPF scored by patients and healthcare providers
timeFrame: Baseline
measure: Correlation between VAS score on stability of IPF scored by patients and healthcare providers
timeFrame: 12 weeks
measure: Correlation between VAS score on stability of IPF scored by patients and healthcare providers
timeFrame: 24 weeks
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Marlies Wijsenbeek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moor CC, Mostard RLM, Grutters JC, Bresser P, Aerts JGJV, Dirksen CD, Kimman ML, Wijsenbeek MS. Patient expectations, experiences and satisfaction with nintedanib and pirfenidone in idiopathic pulmonary fibrosis: a quantitative study. Respir Res. 2020 Jul 23;21(1):196. doi: 10.1186/s12931-020-01458-1.
citation: Moor CC, Mostard RLM, Grutters JC, Bresser P, Aerts JGJV, Chavannes NH, Wijsenbeek MS. Home Monitoring in Patients with Idiopathic Pulmonary Fibrosis. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2020 Aug 1;202(3):393-401. doi: 10.1164/rccm.202002-0328OC.