The Compliance of Varenicline With Short-massage (CV-SM)
Recruitment status was Recruiting
Research indicated that the relapse rate of smokers who attempted to give up smoking without drug and other assistance is up to 90-95% while the successful cessation rate may be improved a lot with assistance to quit smoking. There are two kinds of measures to help smokers quit smoking: one is psychological and behavioral intervention, including the advice to quit smoking provided by doctors during daily health service and smoking cessation hotline; another is provision of drug therapy. 2008 smoking cessation Guidance plays emphasis on the effectiveness of smoking cessation of Varenicline and also on role of doctor's behavioral intervention in smoking cessation as Class A of evidence-based rating; among which, doctor's consultation (three minutes) at minimum intensity is effective; high-intensity consultation (more than ten minutes) is more effective than that of low-intensity consultation; and return visit for more than four times will distinctively improve the smoking abstinence rate. It is unrealistic to apply high-intensity and high-frequency smoking cessation intervention on all smokers due to the busy clinical work of domestic doctors. Systematic and standardized short message intervention system may be helpful to improve abstinence rate. Meanwhile, it can reduce human labor and physical resources, and improve the frequency of follow-up visit to smokers. It is observed during the process of offering smoking cessation services to smokers that, it would be one of the very effective measures to provide timely and useful information to smokers at several critical phases of smoking cessation course (such as three weeks before smoking cessation, prevention of relapse, etc.). Doctors, however, are usually passive during this period and unable to provide assistance to smokers with initiative. As people are more and more aware of the harmfulness of smoking and more and more smokers are increasingly willing to give up smoking, it is necessary to create an instant active information distribution system, which provides immediate active smoking cessation short message support through universally used mobile phone short message service to achieve the purpose of helping them quit smoking.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||The Compliance of Varenicline Usage and the Smoking Abstinence Rate Via Mobile Phone Text Messaging Combine With Varenicline: a Single-blind, Randomised Control Trial|
- Drug compliance varenicline [ Time Frame: 4weeks ] [ Designated as safety issue: Yes ]Drug compliance for 4 weeks: defined as the proportion of patients who use Varenicline for 4 weeks to all the patients in this group.
- Continuous abstinence(CA) rates [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
- Drug compliance for 6, 8, 10 and 12 weeks: the proportion of patients using varenicline for 6, 8,10 and 12 weeks to all the patients;
- Continuous abstinence(CA) rates: These rates are defined as the proportion of participants who met abstinence criteria for weeks 9 through 12 and reported no smoking or use of tobacco products at clinic or telephone visits, confirmed by exhaled carbon monoxide measurement of 10 ppm or less at clinic visits only.
- Long-term abstinence rates: it is the rate at the follow-up of the 24th week and verified by exhaled CO test.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
SM intervention + varenicline
In intervention group, SM is delivered by a standard designed SM platform system. The interactive SM supports are involved and trained professional staff will provide guidance regularly. The drug usage in two groups are the same.
Non-SM intervention group: varenicline
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01656083
|Beijing, Germany, 100029|
|Contact: xu jing, faculty 008610-84205204|
|Contact: liu chao wu, master 008610-84206185|
|Sub-Investigator: chen xin, MD|
|Sub-Investigator: liu chao wu, MD|
|Sub-Investigator: liu chao wu, Master|
|Sub-Investigator: su nan, MD|
|Principal Investigator: yu hong xia, MD|
|Sub-Investigator: lin jiang tao, MD|
|Sub-Investigator: wang tao, MD|
|Principal Investigator: yuan jiang, PHD|
|Principal Investigator: YAN YANG, PHD|