Early Health Warning Intervention in Tobacco Control

Smoking Cessation Clinical Trial

Official title:

A Comprehensive Tobacco Control With Early Health Warning Intervention in High Risk Population of COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04996329
• Other study ID #: 2017YFC2019-255
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: Peking University First Hospital
• Contact: Guangfa Wang, MD
• Phone: +86 13810644029
• Email: wangguangfa[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. aged at 40-75 years old;

2. FEV1/FVC>70% after inhaled bronchodilator

3. current smoker (= 10 pack-years)

4. rate of FEV1 decline >30ml/y

5. lived in a community for more than 1 years and has no plans to move out in the next 4 years

Exclusion Criteria:

1. 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;

2. history of lobectomy and / or lung transplantation;

3. predicted life expectancy less than 3 years;

4. history of severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease;

5. Alcoholism, drug abuse or abuse of toxic solvents;

6. Cannot finish long term follow-up or poor compliance;

7. Do not provide consent

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• early health warning 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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing
China	The Second Hospital of Jilin University	Ch'ang-ch'un
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot
China	Shandong Provincial Hospital Affiliated to Shandong University	Jing'an
China	The First Hospital of Qinhuangdao	Qinhuangdao
China	The Second Hospital of Hebei Medical University	Shijia Zhuang
China	Shanxi Bethune Hospital	Taiyuan
China	Tianjin Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	Henan Provincial People's Hospita	Zhenzhou

Sponsors (10)

Lead Sponsor	Collaborator
Peking University First Hospital	First Affiliated Hospital Xi'an Jiaotong University, Henan Provincial People's Hospital, Second Hospital of Jilin University, Shandong Provincial Hospital, Shanxi Bethune Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First Hospital of Qinhuangdao, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of quitting smoking	keep smoking cessation for more than 6 months	1 year
Secondary	one month smoking cessation rate	stop smoking for more than one month, but less than six months	6 months
Secondary	smoking reduction rate	less than the number of cigarettes before the first intervention	1 year
Secondary	smoking cessation rate at each follow-up	stop smoking for 24 hours or more	6 months
Secondary	relapse rate	relapse rate of smoking	1 year