Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle
NCT ID: NCT06646419
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1368 participants
OBSERVATIONAL
2024-11-13
2026-08-31
Brief Summary
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Detailed Description
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Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks.Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks.The control group will maintain the current usual care practice. Eligible patients will be recruited in both groups and will be followed up every 12 weeks for 48 weeks.
Eligible consented patients will be enrolled consecutively to minimize selection bias. In order to achieve the purpose of continuous enrollment, all patients who visit the outpatient clinic,emergency room, and hospitalized due to exacerbation of COPD will be screened, including newly diagnosed patients or those who have bee n treated.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention group
Intervention is implemented at a hospital level and will change overall daily practice. The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit.Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks.
Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks.
No interventions assigned to this group
Control group
The control group will maintain the current usual care practice.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 40\~80 years
* CAT≥10
* At least two moderate or at least one severe exacerbation history in past 1 year
* Able to sign informed consent
Exclusion Criteria
* Stable COPD (symptom such as cough, sputum and shortness of breath are mild or stable, clinical condition has basically returned to pre-exacerbation)
* Comorbidities require/contraindicate long-term use of glucocorticoid treatment: asthma, interstitial lung disease, sarcoidosis, cystic fibrosis, active tuberculosis recurrent aspiration pneumonia ect.
* Serious comorbidities threaten to life expected survival time no more than 1 year: severe heart disease, severe chronic liver, severe kidney disease, cerebrovascular disease with long-term bed rest and malignant tumours ect.
* Not living in the healthcare area
* Patients currently participating in any other interventional studies
40 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Anyang, , China
Research Site
Baise City, , China
Research Site
Beijing, , China
Research Site
Bijie, , China
Research Site
Changsha, , China
Research Site
Chenzhou, , China
Research Site
Chifeng, , China
Research Site
Chuzhou, , China
Research Site
Deyang, , China
Research Site
Fuyang, , China
Research Site
Hangzhou, , China
Research Site
Hefei, , China
Research Site
Jieyang, , China
Research Site
Jining, , China
Research Site
Jiujiang, , China
Research Site
Kaiyuan, , China
Research Site
Langfang, , China
Research Site
Langzhong, , China
Research Site
Leping, , China
Research Site
Nanchang, , China
Research Site
Nanchong, , China
Research Site
Neijiang, , China
Research Site
Qiannan, , China
Research Site
Qujing, , China
Research Site
Sanmenxia, , China
Research Site
Shaoyang, , China
Research Site
Suzhou, , China
Research Site
Tengzhou, , China
Research Site
Tieling, , China
Research Site
Wenzhou, , China
Research Site
Xiangtan, , China
Research Site
Xiaogan, , China
Research Site
Xinyang, , China
Research Site
Yancheng, , China
Research Site
Yichang, , China
Research Site
Yuling, , China
Research Site
Zaoyang, , China
Countries
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Other Identifiers
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D5980L00025
Identifier Type: -
Identifier Source: org_study_id
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