Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456749
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-07
Brief Title:
Xishui Project for IDM of COPD and Comorbidities
Sponsor:
China-Japan Friendship Hospital
Organization:
China-Japan Friendship Hospital
Study Overview
Official Title:
An Observational Prospective Study on the Integrated Disease Management Effectiveness of COPD and Related Comorbidities in Xishui
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Population 4000 stable COPD patients and among them approximately 2000 subjects with hypertension andor 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 Persons χ² or non-parametric test for categorical data A two-sided p-value 005 is considered statistically significant
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 Persons χ² or non-parametric test for categorical data A two-sided p-value 005 is considered statistically significant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None