Clinical trial NCT06456749: Xishui Project for IDM of COPD and Comorbidities
Official title: An Observational, Prospective Study on the Integrated Disease Management Effectiveness of COPD and Related Comorbidities in Xishui
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Comorbidities and Coexisting Conditions
Keywords: Effectiveness of Integrated Disease Management
Multimorbidity Management
Prosepective Cohort Study
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College
name: Heidelberg University
First posted: 2024-06-13
Enrollment: 4000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed of stable COPD with/without diabetes and/or hypertension.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: FEV1 values
timeFrame: baseline, 24 weeks
measure: Change from baseline in FEV1 values at week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Actual implementation of IDM
timeFrame: 48 weeks
measure: COPD disease outcomes
timeFrame: 48 weeks
measure: Outpatient
timeFrame: 48 weeks
measure: Hospitalization
timeFrame: 48 weeks
measure: Medical expenditure
timeFrame: 48 weeks
measure: Quality of life (by EQ-5D-5L)
timeFrame: 48 weeks
measure: Blood pressure
timeFrame: 48 weeks
measure: Waist circumference
timeFrame: 48 weeks
measure: Blood Glucose
timeFrame: 48 weeks
measure: Body mass index
timeFrame: 48 weeks
measure: Smoking Status
timeFrame: 48 weeks
measure: Smoking Amount
timeFrame: 48 weeks
measure: Alcohol
timeFrame: 48 weeks
measure: Sugared consumption
timeFrame: 48 weeks
measure: Fresh Vegetable Consumption
timeFrame: 48 weeks
measure: Salted Vegetable Consumption
timeFrame: 48 weeks
measure: Physical exercise
timeFrame: 48 weeks
measure: Productivity Loss
timeFrame: 48 weeks
measure: Household consumption expenditures
timeFrame: 48 weeks
measure: Working status
timeFrame: 48 weeks
measure: Saint George Respiratory Questionnaire Score
timeFrame: 48 weeks
Other outcomes:
Locations:
Study officials:
affiliation: China-Japan Friendship Hospital
name: Ting Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Medical Sciences and Peking Union Medical College
name: Chen Wang, MD
role: STUDY_CHAIR
affiliation: Chinese Academy of Medical Sciences and Peking Union Medical College
name: Simiao Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: