NCT04996329

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 9, 2021

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

August 2, 2021

Last Update Submit

August 2, 2021

Conditions

Smoking Cessation

Keywords

smoking cessationbrief smoking cessation interventioncurrent smokersrapid decline in lung function

Outcome Measures

Primary Outcomes (1)

  • rate of quitting smoking

    keep smoking cessation for more than 6 months

    1 year

Secondary Outcomes (4)

  • one month smoking cessation rate

    6 months

  • smoking reduction rate

    1 year

  • smoking cessation rate at each follow-up

    6 months

  • relapse rate

    1 year

Study Arms (2)

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

Other: early health warning intervention

brief smoking cessation intervention group

ACTIVE COMPARATOR

brief smoking cessation intervention only

Other: early health warning intervention

Interventions

early health warning interventionOTHER

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 groupcomprehensive smoking cessation intervention group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

The Second Hospital of Jilin University

Ch’ang-ch’un, China

NOT YET RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, China

RECRUITING

Shandong Provincial Hospital Affiliated to Shandong University

Jing’an, China

NOT YET RECRUITING

The First Hospital of Qinhuangdao

Qinhuangdao, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijia Zhuang, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

RECRUITING

Henan Provincial People's Hospita

Zhenzhou, China

NOT YET RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Guangfa Wang, MD

CONTACT

+86 13810644029wangguangfa@hotmail.com

Jiping Liao, MD

CONTACT

+86 13521714181jipingliao@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 9, 2021

Study Start

April 21, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 9, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)