Early Health Warning Intervention in Tobacco Control
- Conditions
- Smoking Cessation
- Interventions
- Other: early health warning intervention
- Registration Number
- NCT04996329
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- aged at 40-75 years old;
- FEV1/FVC>70% after inhaled bronchodilator
- current smoker (≥ 10 pack-years)
- rate of FEV1 decline >30ml/y
- lived in a community for more than 1 years and has no plans to move out in the next 4 years
- history of asthma, COPD, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease;
- history of lobectomy and / or lung transplantation;
- predicted life expectancy less than 3 years;
- history of severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease;
- Alcoholism, drug abuse or abuse of toxic solvents;
- Cannot finish long term follow-up or poor compliance;
- Do not provide consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description brief smoking cessation intervention group early health warning intervention brief smoking cessation intervention only comprehensive smoking cessation intervention group early health warning intervention 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
- Primary Outcome Measures
Name Time Method rate of quitting smoking 1 year keep smoking cessation for more than 6 months
- Secondary Outcome Measures
Name Time Method relapse rate 1 year relapse rate of smoking
one month smoking cessation rate 6 months stop smoking for more than one month, but less than six months
smoking reduction rate 1 year less than the number of cigarettes before the first intervention
smoking cessation rate at each follow-up 6 months stop smoking for 24 hours or more
Trial Locations
- Locations (10)
The Second Hospital of Jilin University
🇨🇳Ch'ang-ch'un, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, China
Shandong Provincial Hospital Affiliated to Shandong University
🇨🇳Jing'an, China
The Second Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, China
Henan Provincial People's Hospita
🇨🇳Zhenzhou, China
The First Hospital of Qinhuangdao
🇨🇳Qinhuangdao, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China