Xishui Project for IDM of COPD and Comorbidities

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456749
• Other study ID #: 2024-HX-22
• Status: Not yet recruiting
• Start date: June 17, 2024
• Est. completion date: March 15, 2026

Study information

• Verified date: June 2024
• Source: China-Japan Friendship Hospital
• Contact: Ting Yang, MD
• Phone: 84206272
• Email: zryyyangting[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: March 15, 2026
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Comorbidities and Coexisting Conditions
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital	Heidelberg University, Peking Union Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 values	FEV1 values at baseline, and at week 24 in patients with COPD and in patients with COPD without diabetes or hypertension, COPD with hypertension, COPD with diabetes, and COPD with hypertension and diabetes, respectively;	baseline, 24 weeks
Primary	Change from baseline in FEV1 values at week 24	Change from baseline in FEV1 values at week 24 in patients with COPD and in patients with COPD without diabetes or hypertension, COPD with hypertension, COPD with diabetes, and COPD with hypertension and diabetes, respectively;	24 weeks
Secondary	Actual implementation of IDM	Actual implementation of IDM (e.g. clinical visit frequency, treatment adherence, etc.,) of over all patients, and stratified by type of comorbidities.	48 weeks
Secondary	COPD disease outcomes	COPD disease outcomes (Life expectancy/Quality of Life/exacerbation/ mortality etc.) within week 48 and stratified by type of comorbidities.	48 weeks
Secondary	Outpatient	Definition: Clinic or emergency utilization during the study period Functional form: Count Measurement: Medical records	48 weeks
Secondary	Hospitalization	Definition: Hospitalization during the study period (by hospital types) Functional form: Count Measurement: Medical records	48 weeks
Secondary	Medical expenditure	Definition: Expenditure related to healthcare Functional form: Continuous Measurement: Medical records + additional indirect expenditures recalled from questions	48 weeks
Secondary	Quality of life (by EQ-5D-5L)	Definition: General self-rated health status Functional form: Continuous Measurement: EQ-5D instrument	48 weeks
Secondary	Blood pressure	Definition: Systolic and diastolic blood pressure (mmHg) Functional form: Continuous Measurement: Omron portable automated sphygmomanometers	48 weeks
Secondary	Waist circumference	Definition: Waist circumference (cm) Functional form: Continuous Measurement: Soft tape measure	48 weeks
Secondary	Blood Glucose	Definition: glucose level in plasma Functional form: Continuous Measurement: Blood glucose meters	48 weeks
Secondary	Body mass index	Definition: Body mass divided by the square of the body height (kg/m2) Functional form: Continuous Measurement: Calculation	48 weeks
Secondary	Smoking Status	Definition: Do you currently smoke? Functional form: Binary/Continuous Measurement: Recall question answered by individual	48 weeks
Secondary	Smoking Amount	Definition: If so, how many cigarettes do you smoke per day Functional form: Count Measurement: Recall question answered by individual	48 weeks
Secondary	Alcohol	Definition: Frequency of alcohol consumption in the past 3 months Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Secondary	Sugared consumption	Definition: Habit of sugared drink consumption Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Secondary	Fresh Vegetable Consumption	Definition: Habit of fresh vegetables consumption Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Secondary	Salted Vegetable Consumption	Definition: Habit of salted vegetable consumption Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Secondary	Physical exercise	Definition: Types of physical exercise in a typical week Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Secondary	Productivity Loss	Definition: the effect of your health problems on your ability to work and perform regular activities Functional form: Continuous Measurement: Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)	48 weeks
Secondary	Household consumption expenditures	Definition: Total household annual expenditure Functional form: Continuous Measurement: A comprehensive spectrum of expenditure categories answered by household proxy respondent	48 weeks
Secondary	Working status	Definition: Main occupation and type Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Secondary	Saint George Respiratory Questionnaire Score	The overall evaluation of SGRQ score	48 weeks