Набор скоро начнётся NCT07743996

Emotional and Social Experiences of Antifibrotic (AF) Therapy Among Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF) Patients: A Real-World Study

— Наблюдательное Idiopathic Pulmonary Fibrosis Progressive Pulmonary Fibrosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis. Базовые параметры: от 40 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Япония
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Real-World Study of the Perceived Emotional and Social Experiences Related to Antifibrotic Therapy in Patients With IPF and PPF: A Cross-Sectional Web-Based Survey

Обзор

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.

Первичные конечные точки

Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population [Срок оценки: Assessed once at survey completion (approximately 20 minutes after survey initiation).]

Вторичные конечные точки (8)

Mean (95% CI) scores for the PESaM side effects sub-domain by IPF/PPF group, and by AF treatment [Срок оценки: Assessed once at survey completion (approximately 20 minutes after survey initiation).]
Mean (95% CI) scores for the EQ-5D-5L [Срок оценки: Assessed once at survey completion (approximately 20 minutes after survey initiation).]
Mean (95% CI) scores for the SDM-Q-9 [Срок оценки: Assessed once at survey completion (approximately 20 minutes after survey initiation).]
Reliability (Cronbach's α) of PESaM side effects sub-domain [Срок оценки: Assessed once at survey completion (approximately 20 minutes after survey initiation).]
Validity (correlation with EQ-5D-5L) of PESaM side effects sub-domain [Срок оценки: Assessed once at survey completion (approximately 20 minutes after survey initiation).]
Correlation between PESaM side effects sub-domain and SDM-Q-9 [Срок оценки: Assessed once at survey completion (approximately 20 minutes after survey initiation).]
Descriptive statistics of patient background in high- and low-score groups for the PESaM side effects sub-domain [Срок оценки: Assessed once at survey completion (approximately 20 minutes after survey initiation).]
Clinical characteristics in high- and low-score groups for the PESaM side effects sub-domain [Срок оценки: Assessed once at survey completion (approximately 20 minutes after survey initiation).]

Критерии участия

Критерии включения

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
Patients capable of responding to a self-administered questionnaire