Xishui Project for IDM of COPD and Comorbidities

NCT06456749 | Not Yet Recruiting

• 1 other identifier: 2024-HX-22
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease; Comorbidities and Coexisting Conditions

Keywords

Effectiveness of Integrated Disease Management; Multimorbidity Management; Prosepective Cohort Study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• Actual implementation of IDM

  48 weeks

• COPD disease outcomes

  48 weeks

• Outpatient

  48 weeks

• Hospitalization

  48 weeks

• Medical expenditure

  48 weeks

Study Arms (1)

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

Interventions

Integrated Disease Management COMBINATION_PRODUCT

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.

COPD patients with comorbidities

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• Suffering from severe cognitive disorders or total loss of ability of daily living.
• Death.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Peking Union Medical College: collaborator
• Heidelberg University: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ting Yang, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Chen Wang, MD

  Chinese Academy of Medical Sciences and Peking Union Medical College

  STUDY CHAIR

• Simiao Chen, PhD

  Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Yang, MD

CONTACT

84206272; zryyyangting@163.com

Yuhao Liu, PhD student

CONTACT

13031161771; yuhaoliu@pumc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Associate Director of Respiratory Center

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: June 17, 2024
• Primary Completion: October 15, 2025
• Study Completion: March 15, 2026
• Last Updated: June 13, 2024

Record last verified: 2024-06