Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Conditions
Brief summary
This is a cross-sectional study that will be conducted across Japan using an online patient-reported outcome questionnaire. This study tries to find out the attitudes toward and experiences of the emotional and/or social impact of side effects associated with antifibrotic (AF) treatment among Japanese patients with Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF), and how are these attitudes associated with patients' individual characteristics.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with IPF aged 40 years or older who received nintedanib or pirfenidone within the previous 4 weeks, or patients with PPF aged 18 years or older who received nintedanib within the previous 4 weeks 2. Patients capable of responding to a self-administered questionnaire
Exclusion criteria
1. Patients treated with nerandomilast (including clinical trials) 2. Patients with PPF treated with pirfenidone 3. Patients currently hospitalized 4. Patients with malignant tumors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population | Assessed once at survey completion (approximately 20 minutes after survey initiation). | The score of patient experiences and satisfaction with medications (PESaM) side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between PESaM side effects sub-domain and SDM-Q-9 | Assessed once at survey completion (approximately 20 minutes after survey initiation). | The score of of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience. The 9-Item SDM-Q-9 score is derived as a sum of the nine items, each rated on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree) and it ranges from 0 to 45. A higher score indicates a greater degree of patient involvement in the shared decision-making process (reflecting better shared decision-making). |
| Descriptive statistics of patient background in high- and low-score groups for the PESaM side effects sub-domain | Assessed once at survey completion (approximately 20 minutes after survey initiation). | The score of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience. The following descriptive statistics will be reported: * Sex * Age |
| Clinical characteristics in high- and low-score groups for the PESaM side effects sub-domain | Assessed once at survey completion (approximately 20 minutes after survey initiation). | The score of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience. The following clinical characteristics will be reported: * Lung diseases group * AF treatment in use * Disease duration * Severity/use of oxygen therapy |
| Mean (95% CI) scores for the PESaM side effects sub-domain by IPF/PPF group, and by AF treatment | Assessed once at survey completion (approximately 20 minutes after survey initiation). | The score of of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience. |
| Mean (95% CI) scores for the EQ-5D-5L | Assessed once at survey completion (approximately 20 minutes after survey initiation). | The quality of life (Qol) 5 dimensions 5-level (EQ-5D-5L) index score ranges from less than 0 (states valued as worse than death, with a minimum of -0.025 based on the Japanese tariff) to 1 (perfect health). Higher scores indicate a better health-related quality of life. |
| Mean (95% CI) scores for the SDM-Q-9 | Assessed once at survey completion (approximately 20 minutes after survey initiation). | The 9-Item Shared Decision-Making Questionnaire (SDM-Q-9) score is derived as a sum of the nine items, each rated on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree) and it ranges from 0 to 45. A higher score indicates a greater degree of patient involvement in the shared decision-making process (reflecting better shared decision-making). |
| Validity (correlation with EQ-5D-5L) of PESaM side effects sub-domain | Assessed once at survey completion (approximately 20 minutes after survey initiation). | The score of of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience. EQ-5D-5L index score ranges from less than 0 (states valued as worse than death, with a minimum of -0.025 based on the Japanese tariff) to 1 (perfect health). Higher scores indicate a better health-related quality of life. |
| Reliability (Cronbach's α) of PESaM side effects sub-domain | Assessed once at survey completion (approximately 20 minutes after survey initiation). | To evaluate the reliability of the PESaM side effects sub-domain, Cronbach's alpha will be calculated. |
Countries
Japan
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed