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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Comorbidities and Coexisting Conditions
• Intervention / Treatment: Combination product: Integrated Disease Management

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Ting Yang, MD; Phone Number: 84206272; Email: zryyyangting@163.com
• Study Contact Backup: Name: Yuhao Liu, PhD student; Phone Number: 13031161771; Email: yuhaoliu@pumc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed of stable COPD with/without diabetes and/or hypertension.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

COPD patients with comorbidities; Adult patients diagnosed of stable COPD with/without diabetes and/or hypertension.4000 stable COPD patients, and among them approximately 2000 subjects with hypertension and/or type 2 diabetes complications.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Outpatient	Definition: Clinic or emergency utilization during the study period Functional form: Count Measurement: Medical records	48 weeks
Hospitalization	Definition: Hospitalization during the study period (by hospital types) Functional form: Count Measurement: Medical records	48 weeks
Medical expenditure	Definition: Expenditure related to healthcare Functional form: Continuous Measurement: Medical records + additional indirect expenditures recalled from questions	48 weeks
Quality of life (by EQ-5D-5L)	Definition: General self-rated health status Functional form: Continuous Measurement: EQ-5D instrument	48 weeks
Blood pressure	Definition: Systolic and diastolic blood pressure (mmHg) Functional form: Continuous Measurement: Omron portable automated sphygmomanometers	48 weeks
Waist circumference	Definition: Waist circumference (cm) Functional form: Continuous Measurement: Soft tape measure	48 weeks
Blood Glucose	Definition: glucose level in plasma Functional form: Continuous Measurement: Blood glucose meters	48 weeks
Body mass index	Definition: Body mass divided by the square of the body height (kg/m2) Functional form: Continuous Measurement: Calculation	48 weeks
Smoking Status	Definition: Do you currently smoke? Functional form: Binary/Continuous Measurement: Recall question answered by individual	48 weeks
Smoking Amount	Definition: If so, how many cigarettes do you smoke per day Functional form: Count Measurement: Recall question answered by individual	48 weeks
Alcohol	Definition: Frequency of alcohol consumption in the past 3 months Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Sugared consumption	Definition: Habit of sugared drink consumption Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Fresh Vegetable Consumption	Definition: Habit of fresh vegetables consumption Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Salted Vegetable Consumption	Definition: Habit of salted vegetable consumption Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Physical exercise	Definition: Types of physical exercise in a typical week Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
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
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
Working status	Definition: Main occupation and type Functional form: Categorical Measurement: Recall question answered by individual	48 weeks
Saint George Respiratory Questionnaire Score	The overall evaluation of SGRQ score	48 weeks

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Heidelberg University; Peking Union Medical College
• Investigators: Principal Investigator: Ting Yang, MD, China-Japan Friendship Hospital; Study Chair: Chen Wang, MD, Chinese Academy of Medical Sciences and Peking Union Medical College; Principal Investigator: Simiao Chen, PhD, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): June 17, 2024
• Primary Completion (Estimated): October 15, 2025
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Effectiveness of Integrated Disease Management; Multimorbidity Management; Prosepective Cohort Study
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2024-HX-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No