Early Health Warning Intervention in Tobacco Control

NCT ID: NCT04996329

Last Updated: 2021-08-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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comprehensive smoking cessation intervention group

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

Group Type EXPERIMENTAL

early health warning intervention

Intervention Type 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.

brief smoking cessation intervention group

brief smoking cessation intervention only

Group Type ACTIVE_COMPARATOR

early health warning intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Shanxi Bethune Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role collaborator

The First Hospital of Qinhuangdao

OTHER_GOV

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The Second Hospital of Jilin University

Ch’ang-ch’un, , China

Site Status NOT_YET_RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, , China

Site Status RECRUITING

Shandong Provincial Hospital Affiliated to Shandong University

Jing'an, , China

Site Status NOT_YET_RECRUITING

The First Hospital of Qinhuangdao

Qinhuangdao, , China

Site Status RECRUITING

The Second Hospital of Hebei Medical University

Shijia Zhuang, , China

Site Status RECRUITING

Shanxi Bethune Hospital

Taiyuan, , China

Site Status RECRUITING

Tianjin Medical University General Hospital

Tianjin, , China

Site Status RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status RECRUITING

Henan Provincial People's Hospita

Zhenzhou, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Guangfa Wang, MD

Role: CONTACT

+86 13810644029

Jiping Liao, MD

Role: CONTACT

+86 13521714181

Facility Contacts

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Jiping Liao, MD

Role: primary

+86 13521714181

Jinzhi Ying, MD

Role: primary

Xiuhua Fu, MD

Role: primary

Jian Sun, MD

Role: primary

Hua Qiao, MD

Role: primary

Xixin Yan, MD

Role: primary

+86 15803210959

Ruiying Wang, MD

Role: primary

+86 13903436432

Lixia Dong, MD

Role: primary

Xiaomin Dang, MD

Role: primary

Limin Zhao, MD

Role: primary

Other Identifiers

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2017YFC2019-255

Identifier Type: -

Identifier Source: org_study_id

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