NCT06456749

Xishui Project for IDM of COPD and Comorbidities

An Observational, Prospective Study on the Integrated Disease Management Effectiveness of COPD and Related Comorbidities in Xishui

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Comorbidities and Coexisting Conditions

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Integrated Disease Management	For COPD, they are encouraged to seek further cares and manage COPD on a regular basis. For smokers, they will be given a digital health intervention based on CBT. For participants with symptoms of depression or anxiety, another digital health intervention is provided. For abnormal BMI participants, a knowledge brochure will be provided and a medical worker from the township hospital will tell the harm of abnormal BMI. For hypertension and type 2 diabetes, we will actively include them into the National Essential Public Health program.

Timeline

• Start date: 2024-06-17
• Primary completion: 2025-10-15
• Completion: 2026-03-15
• First posted: 2024-06-13
• Last updated: 2024-06-13