Idiopathic Pulmonary FibrosisNCT03420235
Home Monitoring in Idiopathic Pulmonary Fibrosis; Improving Use of Anti-fibrotic Medication and Quality of Life
A study testing Home monitoring program in people with Idiopathic Pulmonary Fibrosis, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Home monitoring program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Jan 2018to 26 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Not able to speak, read or write in Dutch
- No access to internet
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Home monitoring program
- Keywords
- quality of life, eHealth, patient-reported outcomes, home spirometry, cost-effectiveness, home monitoring
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home monitoring programOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group will receive standard care alone. |
| Home monitoring group | Experimental | Intervention will consist of a home monitoring program added to standard care. Receives: Other: Home monitoring program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks after inclusion
Secondary outcomes (16)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 24 weeks after inclusion
FVC decline
FVC decline measured by hospital-based spirometry and daily home spirometry
Measured: 12 weeks after inclusion
FVC decline
FVC decline measured by hospital-based spirometry and daily home spirometry
Measured: 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
Measured: 24 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start9 Jan 2018
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- OLVG, St. Antonius Hospital, Zuyderland Medical Centre
- Responsible party
- Principal investigator, Marlies Wijsenbeek, Erasmus Medical Center
- Investigators
- Marlies Wijsenbeek, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420235
- Sponsor's protocol ID
- NL62925.078.17
- Status last verified
- Jan 2020
- First submitted
- 20 Dec 2017
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32703201Moor 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.
PubMed 32325005
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Monitoring in Idiopathic Pulmonary Fibrosis; Improving Use of Anti-fibrotic Medication and Quality of Life
- ClinicalTrials.gov ID
- NCT03420235
- Acronym / sponsor ID
- NL62925.078.17
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- quality of life, eHealth, patient-reported outcomes, home spirometry, cost-effectiveness, home monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- OLVG, St. Antonius Hospital, Zuyderland Medical Centre
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group will receive standard care alone. |
| Home monitoring group | Experimental | Other: Home monitoring programIntervention will consist of a home monitoring program added to standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- Not able to speak, read or write in Dutch
- No access to internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home monitoring programThe 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). | Other | Home monitoring group |
Primary outcome
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
Time frame: 24 weeks after inclusion
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.
16 secondary outcomes
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
Time frame: 12 weeks after inclusion
Patient-reported outcome (PRO) scores (GRC)
Time frame: 12 weeks after inclusion
Patient-reported outcome (PRO) scores (EQ5D)
Time frame: 12 weeks after inclusion
Patient-reported outcome (PRO) scores (HADS)
Time frame: 12 weeks after inclusion
Patient-reported outcome (PRO) scores (HADS)
Time frame: 24 weeks after inclusion
Patient-reported outcome (PRO) scores (EQ5D)
Time frame: 24 weeks after inclusion
Patient-reported outcome (PRO) scores (GRC)
Time frame: 24 weeks after inclusion
Patient expectations and satisfaction with medication (PESaM scores)
Time frame: Baseline and 12 weeks after inclusion
Patient expectations and satisfaction with medication (PESaM scores)
Time frame: Baseline and 24 weeks after inclusion
Patient satisfaction with medication (PESaM scores)
Time frame: 24 weeks after inclusion
Patient satisfaction with the care process
Time frame: 24 weeks after inclusion
Number of patients who discontinue use of medication, pills used and pills wasted
Time frame: 24 weeks after inclusion
Amount of contacts with healthcare providers and number of visits per patient
Time frame: 24 weeks after inclusion
FVC decline
Time frame: 12 weeks after inclusion
FVC decline
Time frame: 24 weeks after inclusion
Personal goal of patient defined at start of study
Time frame: 24 weeks after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 32703201Moor 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.
- Derived from this study: PubMed 32325005Moor 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlies Wijsenbeek, MD PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home monitoring program in people with Idiopathic Pulmonary Fibrosis, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 24 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420235, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.