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临床试验/NCT02701686
NCT02701686已完成不适用

A Comparison of the Effectiveness of Two Approaches (Quit Immediately: QI and Cut Down to Quit: CDTQ) in Achieving Smoking Abstinence Among Patients Having Follow-up in a GOPC: A Pilot Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
self-reported 7-day point prevalence of abstinence

研究概览

简要总结

The purpose of this study is to test the effectiveness of negotiating self determination to reduce cigarette consumption. A single-blinded multi-centre randomized controlled is employed.

详细描述

Introduction:

A brief intervention with a small to moderate effect size can potentially benefit a large number of smokers and increase smoking cessation within the community if it is carried out routinely in clinical practices by all or most healthcare professionals or people with minimal training. It is also the most cost-effective smoking cessation programme, because no extra or minimal funding is needed to provide the venue, manpower, and other expenses (but incentives or payments to healthcare professionals and follow-up support would be needed). There is no evidence that longer interventions are more effective than shorter interventions. Brief cessation interventions have been shown to be effective with strong evidence from the investigators' randomised controlled trials and in systematic reviews.

The negotiating self-determination to reduce cigarette consumption is guided by social cognitive and self-determination theories. According to social cognitive theory, self-efficacy is an important personal determinant of human behaviour and has been defined as the belief in one's capability to engage in behaviour to solve difficult tasks. This belief influences decisions on whether a certain form of behaviour will be adopted and maintained. Because self-efficacy is built on a successful experience of overcoming challenging tasks, smokers who have more successful experiences in reducing cigarette consumption tend to have higher levels of self-efficacy. Some evidence has shown that a reduction in smoking may lead to greater self-efficacy to resist smoking, which could increase subsequent quitting. According to self-determination theory, autonomy is another influential determinant of behaviours which is emphasized by freedom of choice. Studies have shown that patients having an opportunity to decide on their own treatment may feel more eager to comply with instructions. The subjects in this study will be allowed to select their own schedules of smoking reduction after the negotiation with the counsellor, such as the percentage of smoking reduction over an acceptable period of time. It is anticipated that the subjects will show more willingness to adhere to their own schedule as a result of an increase in autonomy. Moreover, some evidence has shown that autonomy is positively associated with competence; that is, people have greater autonomy demonstrate higher competence in achieving behavioural change. Consequently, autonomy will facilitate their gradual reduction or cessation of smoking. Most importantly, as a result of reducing the cigarette consumption and lowering down the nicotine dependence, it would be much easier for such smokers to further reduce or quit.

Methods:

Chinese patients attending the general out-patient clinics in Hong Kong for routine follow-up visits who fulfil the following inclusion criteria will be invited to participate in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •aged 18 years or above,
  • •smoke at least two cigarettes per day,

排除标准

  • •those with unstable medical conditions as advised by the doctor in charge,
  • •poor cognitive state or mental illness,
  • •participation in other smoking cessation programmes or services.

研究组 & 干预措施

quit immediately (QI)

Experimental

Subjects in the QI group will receive a smoking cessation booklet plus a brief intervention using the AWARD model: (a) Ask about smoking history, (b) Warn about the high risk, (c) Advise to quit now, as quitting can greatly reduce risks, (d) Refer smokers to a smoking cessation clinic, and (e) Do it again: repeat the intervention during each telephone follow-up. The whole intervention will be limited to less than 1 min or slightly longer if necessary. For the subsequent telephone follow-ups at 1, 3, 6 and 12 months, the counsellor will congratulate to the subjects who successfully quit smoking, while deliver the same brief intervention as a booster for those who continue to smoke.

干预措施: quit immediately (QI) (Behavioral)

cut down to quit (CDTQ)

Experimental

Subjects in the CDTQ group will also receive the smoking cessation booklet plus a brief intervention using the AWARD model. Instead of asking them to quit immediately, they will be advised gradually cutting down on their cigarette consumption. Also, the subjects will be provided with an education card that contains reduction strategies and a suggested plan to reduce smoking. For the subsequent telephone follow-ups at 1, 3, 6 and 12 months, the nurse counsellor will repeat the warning message that one out of two smokers will be killed by smoking, and remind the subjects of their next reduction target. The counsellor will congratulate subjects who quit or reduce smoking on their success. When subjects fail to quit or reduce their cigarette consumption, the counsellor will reinforce the health hazards of continued smoking and the benefits of quitting, and encourage them to try again immediately or in the near future.

干预措施: cut down to quit (CDTQ) (Behavioral)

结局指标

主要结局

self-reported 7-day point prevalence of abstinence

时间窗: 12 months

self-reported reduction of ≥ 50% in cigarette consumption

时间窗: 12 months

self-reported 7-day point prevalence of abstinence

时间窗: 6 months

self-reported reduction of ≥ 50% in cigarette consumption

时间窗: 6 months

次要结局

  • self-efficacy in quitting(12 months)
  • number of quit attempts made(12 months)
  • biochemically validated abstinence (exhaled CO test & saliva cotinine test)(12 months)
  • biochemically validated abstinence (exhaled CO test & saliva cotinine test)(6 months)
  • self-efficacy in quitting(6 months)
  • number of quit attempts made(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. LI William Ho Cheung

Principal Investigator

The University of Hong Kong

研究点 (1)

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