An Observational Registry of Chinese COPD Study
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: COPD. Базовые параметры: от 20 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
An Observational Registry Study for Management of COPD Patients in China
Обзор
This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. The objective is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China.
Подробное описание
COPD is the most common chronic respiratory disease in China and has caused significant economic and humanistic burden. Patient reported outcomes (PRO) have been widely used to assess disease activity and quality of life for COPD patients. Wearable devices enable recording activity data of patients continuously and automatically. The objective of the study is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China. This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. 3000-5000 participants are planned to be recruited. Each participant will be followed-up at baseline and every 3 months. Clinical assessment data, laboratory examination data and cost data are captured from electronic medical records (EMR). Patient-reported outcome (PRO) data are collected via smartphone app. Part of patients will receive wearable devices to record digital health technology (DHT) data. As the first ever observational registry focused on COPD stable-period management, this study can provide more information on these following issues. (1) Annual changes in COPD prevalence, treatment pattern and economic burden in China. (2) Assessing the real-world effectiveness and safety of different treatment patterns of COPD via EMR, PRO and DHT. (3) Cost-effectiveness and budget impact to the public healthcare funds of different treatment patterns of COPD.
Первичные конечные точки
- Characterize COPD Disease Severity in Clinical Practice [Срок оценки: 2 years]
- Characterize COPD Disease Activity in Clinical Practice [Срок оценки: 2 years]
Вторичные конечные точки (4)
- Evaluate Medical Expenditure in Clinical Practice [Срок оценки: 2 years]
- Evaluate Patient Reported Outcome [Срок оценки: 2 years]
- Evaluate Health Related Quality of Life [Срок оценки: 2 years]
- Evaluate Digital Health Technology Outcome [Срок оценки: 2 years]
Критерии участия
Критерии включения
- Adults age 40 or older with a diagnosis of chronic obstructive pulmonary disease (COPD) having been prescribed any COPD treatment (initial or subsequent) outside of a clinical trial.
- Have plans for future visits at the site for continued management of COPD.
Критерии исключения
- Inability to provide written informed consent/assent.
- Being enrolled in any interventional study or trial for COPD treatment. Note: Patient may be enrolled in other registries or studies where COPD treatment outcomes are observed and/or reported (such as center-based registries).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Tang X, Pan J, Fang F, Li Y, Lei J, Niu H, Li W, Dong F, Zheng Z, Peng Y, Yang T, Wang C, Jia C, Huang K. Characteristics and risk factors of patients with undiagnosed COPD in China: results of a nationwide study from the 'Happy Breathing' Programme with mixed methods evaluation. BMJ Health Care Inform. 2025 Oct 7;32(1):e101323. doi: 10.1136/bmjhci-2024-101323. PMID 41057271
- Gao B, Wang S, Zhao L, Liao H, Qumu S, Wang P, Yang T, Jiang S. Characteristics and Quality of Life of Patients with COPD with Different Degrees of Exercise-Induced Desaturation on Six-minute Walk Test. Int J Chron Obstruct Pulmon Dis. 2025 Jul 14;20:2381-2391. doi: 10.2147/COPD.S513089. eCollection 2025. PMID 40688240
- Wang S, Gao B, Shi M, Qumu S, Dong F, Wang P, Yang T, Jiang S. Exercise-Induced Oxygen Desaturation Increases Arterial Stiffness in Patients with COPD During the 6WMT. Int J Chron Obstruct Pulmon Dis. 2024 Jun 26;19:1479-1489. doi: 10.2147/COPD.S465843. eCollection 2024. PMID 38948910
- Jia C, Zhang C, Fang F, Huang K, Dong F, Gu X, Niu H, Li S, Wang C, Yang T. Enjoying Breathing Program: A National Prospective Study Protocol to Improve Chronic Obstructive Pulmonary Disease Management in Chinese Primary Health Care. Int J Chron Obstruct Pulmon Dis. 2020 Sep 15;15:2179-2187. doi: 10.2147/COPD.S258479. eCollection 2020. PMID 32982210
Идентификаторы
NCT: NCT04318912 · 21971