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Xishui Project for IDM of COPD and Comorbidities

NCT06456749 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2024-06-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peking Union Medical College

    collaborator OTHER

  • Heidelberg University

    collaborator OTHER

  • China-Japan Friendship Hospital

    lead OTHER

Principal Investigators

  • Ting Yang, MD · China-Japan Friendship Hospital

  • Chen Wang, MD · Chinese Academy of Medical Sciences and Peking Union Medical College

  • Simiao Chen, PhD · Chinese Academy of Medical Sciences and Peking Union Medical College

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2025-10-15
Completion
2026-03-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06456749 on ClinicalTrials.gov