An Observational, Prospective Study on the Integrated Disease Management Effectiveness of COPD and Related Comorbidities in Xishui
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,000
- 主要终点
- FEV1 values
研究概览
简要总结
Study Population: 4000 stable COPD patients, and among them approximately 2000 subjects with hypertension and/or type 2 diabetes complications.
Design: Cohort Study Primary Objectives: The primary objective of this study is to access the effectiveness of IDM on changes in FEV1 from baseline to the 24th week visit in patients with COPD.
Statistical Analysis: We plan to compare demographic differences between groups based on whether the data conformed to normal distribution and satisfied variance chi-square, and proposed to calculate p-values using the t-test or non-parametric test for continuous data and Person's χ² or non-parametric test for categorical data. A two-sided p-value < 0.05 is considered statistically significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥40 years;
- •Stable COPD patients with post-bronchodilator FEV1/FVC <70% or previously diagnosed of COPD by physicians and confirmed by PFT;
- •With/without diabetes and/or hypertension;
- •Permanent resident of Xishui (not expected to leave the area within 1 year).
排除标准
- •Suffering from severe cognitive disorders or total loss of ability of daily living.
结局指标
主要结局
FEV1 values
时间窗: baseline, 24 weeks
FEV1 values at baseline, and at week 24 in patients with COPD and in patients with COPD without diabetes or hypertension, COPD with hypertension, COPD with diabetes, and COPD with hypertension and diabetes, respectively;
Change from baseline in FEV1 values at week 24
时间窗: 24 weeks
Change from baseline in FEV1 values at week 24 in patients with COPD and in patients with COPD without diabetes or hypertension, COPD with hypertension, COPD with diabetes, and COPD with hypertension and diabetes, respectively;
次要结局
- Saint George Respiratory Questionnaire Score(48 weeks)
- Actual implementation of IDM(48 weeks)
- Hospitalization(48 weeks)
- Blood pressure(48 weeks)
- Physical exercise(48 weeks)
- Blood Glucose(48 weeks)
- Body mass index(48 weeks)
- COPD disease outcomes(48 weeks)
- Outpatient(48 weeks)
- Waist circumference(48 weeks)
- Alcohol(48 weeks)
- Salted Vegetable Consumption(48 weeks)
- Productivity Loss(48 weeks)
- Quality of life (by EQ-5D-5L)(48 weeks)
- Sugared consumption(48 weeks)
- Household consumption expenditures(48 weeks)
- Working status(48 weeks)
- Medical expenditure(48 weeks)
- Smoking Status(48 weeks)
- Smoking Amount(48 weeks)
- Fresh Vegetable Consumption(48 weeks)
研究者
Ting YANG
Professor, Associate Director of Respiratory Center
China-Japan Friendship Hospital