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临床试验/NCT01656083
NCT01656083Unknown不适用

The Compliance of Varenicline Usage and the Smoking Abstinence Rate Via Mobile Phone Text Messaging Combine With Varenicline: a Single-blind, Randomised Control Trial

yu hong xia1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
220
试验地点
1
主要终点
Drug compliance varenicline

研究概览

简要总结

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.

详细描述

Study design Random, parallel and control method is adopted.

  1. Group division: random group division SM intervention group: SM intervention + varenicline Non-SM intervention group: varenicline
  2. Method design Random, parallel and control method is adopted. 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.

Group Baseline 1st week 2nd week 3rd week 4th week 8th week 12th week 24th week Intervention Record Smoking history, consulting SM SM SM SM + Visit SM + Telephone visit SM + Visit SM + Visit Control Visit Telephone visit Visit Visit

Study population In this research, professional biostatistical staffs adopt SAS program to divide groups in the trial. The sample size is calculated based on drug compliance rate. Since lack of the data related to varenicline combined SM intervention, the similar trials in the past are taken as reference, but mostly based on the experiences of the investigator's, the mean treatment time for patients using Varenicline is 4 weeks, the proportion of patients who use Varenicline for 4 weeks is about 40%; when combined SM intervention, it supposed to increase to 60% . When use 80% power and 0.05 significance for calculation, the sample size is 192, 96 for each group. Considering the drop rate is about 15%, 220 qualified subjects are included in random group division.

Treatment program

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Smoking over 10 years
  • Over 10 cigarettes each day
  • Age 18 to 70 years
  • Have strong motivation to quit smoking
  • Be suitable and willing to receive Varenicline treatment
  • Be able to receive SM and willing to receive relevant information
  • Sign the Informed Consent Form

排除标准

  • Serious abnormality of liver and kidney functions
  • Have serious skin allergy or mental diseases history, or any other disease not suitable for using Varenicline
  • Alcohol abuse or other drug abuse
  • Any concomitant illness or mental condition that could interfere with the study
  • Any conditions indicating study subjects uncooperative
  • Unable to receive or read SM
  • Any subject that Investigators think not to be suitable for enrollment.

结局指标

主要结局

Drug compliance varenicline

时间窗: 4weeks

Drug compliance for 4 weeks: defined as the proportion of patients who use Varenicline for 4 weeks to all the patients in this group.

次要结局

  • Continuous abstinence(CA) rates(24weeks)

研究者

发起方
yu hong xia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yu hong xia

Department of respirtory medicine&smoking cessation clininc

China-Japan Friendship Hospital

研究点 (1)

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