Xishui Project for IDM of COPD and Comorbidities
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorChina-Japan Friendship Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Suffering from severe cognitive disorders or total loss of ability of daily living.
Death.
Trial design
Treatments tested in this trial
- Integrated Disease Management
Treatment groups
4,000 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
China-Japan Friendship Hospital
Lead sponsor
Peking Union Medical College
Collaborator
Heidelberg University
Collaborator
Source ClinicalTrials.gov