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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-HX-17/214373 | Other Grant/Funding Number | GlaxoSmithKline |
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This is a multi-center, parallel-group,cluster randomised trial involving secondary hospitals across China. The objective is to evaluate the effect of COPD on reducing moderate-to-severe exacerbations during 12 months follow-up in primary-level medical institutions.
COPD is the most common chronic respiratory disease in China. An effective and standardized condition management strategy is urgently needed to prevent acute exacerbation, improve the quality of life, and avoid premature death due to COPD. COPD management is mainly performed in community-level health institutions. Implementing COPD standardized management in primary care will help improve the level of COPD prevention and treatment in China.
The investigators will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial. An estimated number of 96 secondary hospitals across the country will be involved. Each hospital plans to enroll 36 patients with COPD. The hospitals will be randomly allocated into standardized management (SM) group and control group. In SM group, standardized COPD management based-on guidelines will be delivered to patients, including inhaler use for initial and maintenance therapy, regular follow-up, long-term monitoring of lung function and respiratory symptoms, patient education, and favorable lifestyle changes. In control group, patients will receive routine care as usual. In both groups, moderate and severe exacerbations will be collected within 12 months follow-up after randomization. Group difference in annual exacerbation rate will be examined to evaluate the effect of standardized management of COPD on acute exacerbation of COPD in primary care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized management | Experimental | Patients will be managed according to recommendations in GOLD guideline and China's guidelines for COPD care. |
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| Usual care | Other | Patients will undergo usual care according to current clinical practice in study sites. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized COPD management | Behavioral | In standardized management group, patients will receive a multifaceted and integrated disease management that follows recommendations in GOLD 2020 and China Guideline on COPD care. It contains the components below.
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | The primary outcome is annual rate of moderate and severe exacerbation, which will be identified from medical records on the HIS system and patient report at 6 and 12 months assessments | 12 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Exacerbation events | Time to first moderate exacerbation in days, time to first severe exacerbation in days, time to first exacerbation-related hospitalization in days, time to first exacerbation-related emergency admissions in days, time elapsed from patient enrollment until first admission for acute exacerbation in days | 12 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse event | Number of patients with pneumonia caused by ICS-containing treatment, number of patients with tobacco cessation related adverse events, number of patients with pulmonary rehabilitation related adverse events, number of patients with flu vaccination related adverse events, number of patients with pneumonia vaccination related adverse events | 12 months from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Yang, MD, Ph.D | Contact | 13651380809 | dryangting@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen Wang, MD, Ph.D | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27626508 | Background | Khakban A, Sin DD, FitzGerald JM, McManus BM, Ng R, Hollander Z, Sadatsafavi M. The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective. Am J Respir Crit Care Med. 2017 Feb 1;195(3):287-291. doi: 10.1164/rccm.201606-1162PP. No abstract available. | |
| 17132052 |
| Label | URL |
|---|---|
| GOLD guidelines | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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A parallel, cluster randomized trial
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Statisticians and outcome assessors will be blinded
|
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| Routine COPD management | Other | Patients will undergo usual care according to current clinical practice in study sites. Usual care is the routine care provided to patients. Prescription and dispense of medicine for COPD initial and maintenance therapy will be at the discretion of doctors. |
|
| Hospital readmissions | Number of readmissions within 30 days after discharge, time to first readmission within 30 days after discharge in days, number of readmissions within 90 days after discharge, time to first readmission within 90 days after discharge in days | 12 months from baseline |
| Hospital stay | Average length of hospital stay in days | 12 months from baseline |
| Healthcare cost | Total COPD-related health care cost in rmb | 12 months from baseline |
| Lung function change | Change in FEV1 from baseline to 12 months in liter | 12 months from baseline |
| Symptom change | Units on SGRQ-C score change from baseline to 12 months, units on CAT score change from baseline to 12 months, units on mMRC score change from baseline to 12 months | 12 months from baseline |
| Patients' care-seeking behaviors | Number of patients' contacting physicians for medical advice, number of patients' hospital visits to seek care | 12 months from baseline |
| Patients' adherence to treatment | Time of patients' adherence to inhaler medication use in days | 12 months from baseline |
| Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442. |
| 29650248 | Background | Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9. |
| 40623795 | Derived | Dong F, Su R, Ren Y, Huang K, Li W, Yang L, Li X, Hu X, Ye T, Jin D, Yang T, Jones PW, Wang C. Real-world effectiveness study of guideline-directed COPD STANDARDized management in patients with chronic obstructive pulmonary disease: a cluster randomised trial design. BMJ Open Respir Res. 2025 Jul 7;12(1):e002768. doi: 10.1136/bmjresp-2024-002768. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |