Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
Home Monitoring in Idiopathic Pulmonary Fibrosis; Improving Use of Anti-fibrotic Medication and Quality of Life
Verified date | January 2020 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | August 26, 2019 |
Est. primary completion date | August 26, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus MC | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | OLVG, St. Antonius Hospital, Zuyderland Medical Centre |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Home monitoring values of FVC compared to in hospital values of lung function | Home monitoring values compared to in hospital values of lung function | 12 weeks after inclusion | |
Other | Home monitoring values of FVC compared to in hospital values of lung function | Home monitoring values compared to in hospital values of lung function | 24 weeks after inclusion | |
Other | Correlation between FVC measurements and K-BILD | Correlation between FVC and K-BILD. 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 | |
Other | Correlation between FVC measurements and K-BILD | Correlation between FVC and K-BILD. 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 | |
Other | Correlation between FVC measurements and EQ5D | Correlation between FVC and EQ5D. The EQ5D is 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 | |
Other | Correlation between FVC measurements and EQ5D | Correlation between FVC and EQ5D. The EQ5D is 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 | |
Other | Correlation between FVC measurements and HADS | Correlation between FVC and HADS. The HADS is 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 | |
Other | Correlation between FVC measurements and HADS | Correlation between FVC and HADS. The HADS is 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 | |
Other | Correlation between FVC measurements and GRC | Correlation between FVC and GRC. The Global Rating of Change (GRC) 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 | |
Other | Correlation between FVC measurements and GRC | Correlation between FVC and GRC. The Global Rating of Change (GRC) 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 | |
Other | Correlation between VAS score on stability of IPF scored by patients and healthcare providers | Both patients and healthcare providers will score a Visual Analogue Scale (VAS) with a score between 0 (not stable) and 10 (very stable) on stability of IPF at baseline. Correlation between the VAS scores from patients and healthcare providers will be assessed. | Baseline | |
Other | Correlation between VAS score on stability of IPF scored by patients and healthcare providers | Both patients and healthcare providers will score the stability of their IPF on a Visual Analogue Scale (VAS). The visual analogue scale has a score between 0 (very unstable) and 10 (very stable), therefore higher scores correspond with better outcomes. Correlation between the VAS scores from patients and healthcare providers will be assessed at 12 weeks. | 12 weeks | |
Other | Correlation between VAS score on stability of IPF scored by patients and healthcare providers | Both patients and healthcare providers will score the stability of their IPF on a Visual Analogue Scale (VAS). The visual analogue scale has a score between 0 (very unstable) and 10 (very stable), therefore higher scores correspond with better outcomes. Correlation between the VAS scores from patients and healthcare providers will be assessed at 24 weeks. | 24 weeks | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | FVC decline | FVC decline measured by hospital-based spirometry and daily home spirometry | 12 weeks after inclusion | |
Secondary | FVC decline | FVC decline measured by hospital-based spirometry and daily home spirometry | 24 weeks after inclusion | |
Secondary | 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 |
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