Xishui Project for IDM of COPD and Comorbidities

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Chronic Obstructive Pulmonary Disease; Comorbidities and Coexisting Conditions

Treatments: Combination Product: Integrated Disease Management

Study type: Observational

Funder types: Other

Identifiers

NCT06456749

2024-HX-22

Details and patient eligibility

About

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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• Suffering from severe cognitive disorders or total loss of ability of daily living.
• Death.

Trial design

4,000 participants in 1 patient group

COPD patients with comorbidities

Description:

Adult patients diagnosed of stable COPD with/without diabetes and/or hypertension.4000 stable COPD patients, and among them approximately 2000 subjects with hypertension and/or type 2 diabetes complications.

Treatment:

Combination Product: Integrated Disease Management