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| Name | Class |
|---|---|
| The Second Hospital of Hebei Medical University | OTHER |
| Henan Provincial People's Hospital | OTHER |
| Second Hospital of Jilin University | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University |
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This is a multi-center, randomized, controlled intervention clinical trial. A total of 1000 current smokers with rapid decline in lung function will be recruited and equally divided into two groups, comprehensive smoking cessation intervention group (early health warning intervention combined with brief smoking cessation intervention) and brief smoking cessation intervention group. It is aimed to evaluate whether early health warning intervention will increase the rate of smoking cessation.
This is a multi-center, randomized, controlled intervention clinical trial. A total of 1,000 current smokers ( ≥ 10 pack-years) with rapid decline in lung function will be recruited from Predictive Value of Inflammatory Biomarkers and FEV1 for COPD (PIFCOPD) study (clinical trails. gov ID NCT03532893) after 1 year of follow-up. Subjects will be qually divided into two groups, comprehensive smoking cessation intervention group (early health warning intervention combined with brief smoking cessation intervention) and brief smoking cessation intervention group. Health warning intervention is to tell the subjects that smoking leads to the rapid decline of their lung function, and they are at the high risk of developing COPD. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Other 9 units participating in the study, include the The Second Hospital of Hebei Medical University, Henan Provincial People's Hospital, The Second Hospital of Jilin University, The First Affiliated Hospital of Xi'an Jiaotong University, Shandong Provincial Hospital Affiliated to Shandong University, Shan xi Dayi Hospital(Shanxi Academy of Medical Sciences), Tianjin Medical University General Hospital, The Affiliated Hospital of Inner Mongolia University. Some questionnaire about tobacco dependence, depression, anxiety, the willingness to quit smoking and withdrawal symptoms will be collected. Exhaled CO will be measured. Subjects will recived 6 times of smoking cessation intervention in 6 month and followed in another 6 month. The primary outcome is the rate of quitting smoking. The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2019-255). Any protocol modifications will be submitted for the IRB review and approval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comprehensive smoking cessation intervention group | Experimental | Early health warning intervention combined with brief smoking cessation intervention Early health warning intervention is to tell the subjects that smoking leads to the rapid decline of their lung function, and they are at the high risk of developing COPD |
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| brief smoking cessation intervention group | Active Comparator | brief smoking cessation intervention only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early health warning intervention | Other | early health warning intervention is to tell the subjects that smoking leads to the rapid decline of their lung function, and they are at the high risk of developing COPD. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of quitting smoking | keep smoking cessation for more than 6 months | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| one month smoking cessation rate | stop smoking for more than one month, but less than six months | 6 months |
| smoking reduction rate | less than the number of cigarettes before the first intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guangfa Wang, MD | Contact | +86 13810644029 | wangguangfa@hotmail.com | |
| Jiping Liao, MD | Contact | +86 13521714181 | jipingliao@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Shanxi Bethune Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| The First Hospital of Qinhuangdao | OTHER_GOV |
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| 1 year |
| smoking cessation rate at each follow-up | stop smoking for 24 hours or more | 6 months |
| relapse rate | relapse rate of smoking | 1 year |
| The Second Hospital of Jilin University | Not yet recruiting | Ch’ang-ch’un | China |
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| The Affiliated Hospital of Inner Mongolia Medical University | Recruiting | Hohhot | China |
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| Shandong Provincial Hospital Affiliated to Shandong University | Not yet recruiting | Jing’an | China |
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| The First Hospital of Qinhuangdao | Recruiting | Qinhuangdao | China |
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| The Second Hospital of Hebei Medical University | Recruiting | Shijia Zhuang | China |
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| Shanxi Bethune Hospital | Recruiting | Taiyuan | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | China |
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| Henan Provincial People's Hospita | Not yet recruiting | Zhenzhou | China |
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