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临床试验/NCT02645838
NCT02645838Unknown不适用

Motivational Interviewing Versus Brief Advice for Smoking Cessation in General Practice

Capital Medical University0 个研究点目标入组 210 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
210
主要终点
1 week point prevalence abstinence (PPA)

研究概览

简要总结

The purpose of this study is to determine whether or not motivational interviewing is effective in smoking cessation at general practice setting in China.

详细描述

OBJECTIVES:

• To compare the effectiveness of motivational interviewing versus brief advice by conducting a randomized controlled trial in General Practice Setting in China.

OUTLINE:

This is a randomized controlled study. Patients are randomized to either the intervention arm or the control arm.

• Arm I (intervention): Patients will be given a 20 minutes personal talk in the family physician's office during the visit. The family physicians will determine the stage of change in smoking cessation (precontemplative, contemplative, action, maintenance and relapse) and use the motivational interviewing skills during the talk. The motivational interviewing skills include expressing empathy, developing discrepancy, rolling with resistance, supporting self efficacy. Up to six phone calls will be given to the patients during the follow-up, using the motivational interviewing skill.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18 and 80 years.
  • Any person who replies "Yes" when asked "Do you smoke?".
  • Agree to participate the trial and be followed for at least one year.

排除标准

  • With severe mental illness, serious drug dependent patients.
  • Cannot understand conversation or cannot communicate, such as deafness or dementia.
  • Cannot be followed up for one year, such as not likely survive for more than one year.

结局指标

主要结局

1 week point prevalence abstinence (PPA)

时间窗: Self-reported PPA at 1 week follow-up

Validation: exhaled carbon monoxide (CO) (\< 10 ppm)

次要结局

  • 1 month PPA(Self-reported 7-day PPA at 1 month follow-up)
  • 3 month PPA(Self-reported 7-day PPA at 3 month follow-up)
  • 6 month PPA(Self-reported 7-day PPA at 6 month follow-up)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yafang Huang

MD, PHD

Capital Medical University

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