Study on the Model of Smoking Cessation Intervention and Service Ability Improvement

• Conditions: Smoking Cessation
• Interventions: Behavioral: Consulting; Behavioral: Consulting+Telephone+Drug intervention; Drug: Nicotine patch; Behavioral: Telephone intervention

• Registration Number: NCT01935505
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.

Detailed Description

This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.

To study the intervention methods of smoking cessation in a general hospital and to evaluate their effects. Four methods of specialist intervention of smoking cessation clinic, short-time intervention in out patients, free medical intervention and group intervention were adopted for different smokers, with health counseling, psychological intervention and drug treatment. The intervention effect was evaluated by standard methods.

The whole project will last for 10 years in total, from Oct.2008 to Dec.2018. During the running, each quitter received follow-up at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview, an expected average of 2 years.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2013-08-25
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study First Submitted QC: 2013-09-04
• Last Update Submitted: 2013-09-04
• Study First Posted: 2013-09-05
• Last Update Posted: 2013-09-05
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• current smoker aged 18 years or above, Chinese,
• agreed to participate in the follow-up and signed an informed consent form.

Exclusion Criteria

• cognitively impaired and with severe diseases,
• occasional or daily smoker,
• Disagree and non-signed an informed consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug intervention group	Nicotine patch	According to the smokers' level of nicotine dependency, disease history, cigarette consumption, prescription of drugs were provided, Nicotine Replacement Therapy, bupropion and varenicline.
Consulting group	Consulting	The physicians adopted a non-directive approach, included the five 'A' (ask, advice, assess, assist and arrange), assessing the stage of readiness in quitting smoking, strengthening clients' motivation to quit smoking using the five 'R' (relevance, risks, rewards, roadblocks and repetition) approach, and providing advice to overcome psychological craving, psychological dependence and social-cultural factors associated with tobacco dependency. Each smoker takes more than 30 min to complete the intervention.
Drug intervention group	Consulting	According to the smokers' level of nicotine dependency, disease history, cigarette consumption, prescription of drugs were provided, Nicotine Replacement Therapy, bupropion and varenicline.
Drug intervention group	Telephone intervention	According to the smokers' level of nicotine dependency, disease history, cigarette consumption, prescription of drugs were provided, Nicotine Replacement Therapy, bupropion and varenicline.
Consulting+Telephone+Drug intervention	Consulting+Telephone+Drug intervention	All the interventions above are include in this group
Telephone intervention group	Consulting	Smokers received follow-up by a counselor at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview. At each follow-up, we collected data, asked whether the smokers have any problem with drug use or other problems, provided problem-oriented suggestions or advice as appropriate, encouraged them to insist.
Telephone intervention group	Telephone intervention	Smokers received follow-up by a counselor at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview. At each follow-up, we collected data, asked whether the smokers have any problem with drug use or other problems, provided problem-oriented suggestions or advice as appropriate, encouraged them to insist.

Primary Outcome Measures

Name	Time	Method
quitting rate	up to 10 years	The whole project will last for 10 years in total, from Oct.2008 to Dec.2018. During the running, each participant will be followed by telephone tracking, an expected average of 2 years.

Secondary Outcome Measures

Name	Time	Method
decrease of tobacco consumption	up to 10 years