Early Health Warning Intervention in Tobacco Control

August 2, 2021 updated by: Peking University First Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Ch'ang-ch'un, China
        • Not yet recruiting
        • The Second Hospital of Jilin University
        • Contact:
      • Hohhot, China
        • Recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
      • Jing'an, China
        • Not yet recruiting
        • Shandong Provincial Hospital Affiliated to Shandong University
        • Contact:
      • Qinhuangdao, China
        • Recruiting
        • The First Hospital of Qinhuangdao
        • Contact:
      • Shijia Zhuang, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
      • Taiyuan, China
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Xi'an, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Zhenzhou, China
        • Not yet recruiting
        • Henan Provincial People's Hospita
        • Contact:
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Active Comparator: brief smoking cessation intervention group
brief smoking cessation intervention only
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of quitting smoking
Time Frame: 1 year
keep smoking cessation for more than 6 months
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
one month smoking cessation rate
Time Frame: 6 months
stop smoking for more than one month, but less than six months
6 months
smoking reduction rate
Time Frame: 1 year
less than the number of cigarettes before the first intervention
1 year
smoking cessation rate at each follow-up
Time Frame: 6 months
stop smoking for 24 hours or more
6 months
relapse rate
Time Frame: 1 year
relapse rate of smoking
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017YFC2019-255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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