Brief Tobacco Cessation Intervention: a Randomized Controlled Trial in Guangdong, China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,671
- 试验地点
- 1
- 主要终点
- Smokers' self-reported 7-day point prevalence quitting rate
研究概览
简要总结
Traditional smoking cessation clinics and telephone quitlines are expensive and 'passive' as they require motivated smokers to visit the clinic or make a phone call to seek help. However, in most middle-resource countries, smoking cessation clinics are not well publicized. Most health care professionals (HCP) are not active in performing smoking cessation counselling to their patients. They are not aware of the available smoking cessation services or the benefits of such services and hence do not refer smokers to smoking cessation services. On the other hand, physicians play a critical role in reducing tobacco use by advising smoking patients to quit (Richmond, 1999). Physician's advice to quit smoking not only motivates smokers to quit but also increases their quitting confidence (Fiore et al., 2000; Ossip-Klein et al., 2000).
Brief smoking cessation interventions have been shown to be effective with strong evidence from randomized controlled trials (RCTs), however, it is no evidence to show that longer interventions are more effective than shorter interventions. If carried out in routine clinical practice by all physicians and other HCP, brief interventions can potentially benefit a great number of smokers and increase smoking cessation rate. Therefore, we propose to examine the effect of a brief smoking cessation counselling intervention (10-20 seconds AWARD model) among patients using a randomized controlled trail (RCT) design in Guangdong province, China
This project aims to evaluate the effect of physicians' brief smoking cessation intervention (AWARD model) in real busy clinic settings using a randomized controlled trial (RCT) design.
详细描述
Smokers will be recruited from the internal medicine outpatient clinics at the participating hospitals (the general nonprofit public hospitals) and community health centers. Same as the pilot study, trained doctors will ask all visiting patients during clinic consultation whether they smoke, confirm eligibility, provide information sheet and seek oral agreement to be followed up by telephone after clinic consultation. If eligible and oral consent obtained, the doctor will fill the recruitment form.
The doctors will randomly allocate the enrolled patient into intervention or control group using SNOSE method. This method will ensure allocation concealment. If the patient refuses to participate, the doctor will note on the summary form. Enrolled patients' medical records will be marked with a sticker (red for intervention group, green for control group) so they will not be recruited again if they come back to the participating hospital.
At the end of each clinic session, the doctors will immediately fill the rest part of the summary form and send the recruitment form and summary form to trained research assistants by email or WeChat. The research assistants will enter all information into a web-based or app-based study management system (SMS) using tablet PC.
For smokers in intervention group, the doctor will offer a brief (10-20 seconds) WAR smoking cessation intervention (Warn the smokers that at least one out of two smokers will be killed by smoking, and according to WHO, two out of three smokers will be killed by smoking; Advice the smokers to quit now or as soon as possible; and Refer the smokers to a smoking cessation clinic or telephone quitlines by offering a referral card which contains the contact information of the smoking cessation clinics and/or quitlines as well as a pictorial information leaflet which explains the risks of smoking). For control group, the doctor will offer a brief (10-20 seconds) placebo intervention (Advice the smokers to eat vegetables, and offer the smokers a card which contains information about the benefits of eating vegetables and a pictorial information leaflet which shows the recommended amount of vegetables and fruits an adult should eat a day).
Within 3 days after enrolment (T1), study personnel will call the participants using the tablet PC with questionnaire program to invite them to complete a short baseline survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Outpatients aged 18 years or above
- •Smoke on at least 1 day in the past 30 days
- •Chinese residents able to communicate in Chinese (Mandarin or Cantonese)
- •Has a telephone
排除标准
- •Smokers currently receiving smoking cessation interventions
- •Smokers currently enrolled in other smoking cessation trials
- •Smokers who need special care on quitting and are not suitable for AWARD intervention (determined by his/her doctor)
- •Smokers with communication difficulties (physical or cognitive condition)
研究组 & 干预措施
Control Group
The doctor will offer a placebo intervention.
干预措施: Placebo intervention (Behavioral)
Intervention Group A
The doctor will offer the brief smoking cessation AWARD model .
At 1-month follow-up survey, trained study personnel will repeat the brief smoking cessation AWARD model .
干预措施: The brief smoking cessation AWARD model (Behavioral)
Intervention Group B
The doctor will offer the brief smoking cessation AWARD model.
干预措施: The brief smoking cessation AWARD model (Behavioral)
结局指标
主要结局
Smokers' self-reported 7-day point prevalence quitting rate
时间窗: up to 12-months follow-up
Self-reported tobacco abstinence in the past 7 days
次要结局
- Body weight(1-, 3-, 6- and 12-month FU)
- Biochemically validated quit rate(6- and 12-months follow-up)
- Non-biochemically validated quit rate(6- and 12-months follow-up)
- Self-reported sustained nicotine abstinence(1- and 3-month follow-up)
- Smoking reduction (cigarette or other tobacco product use decreased by at least 50%) among continuing smokers(1-, 3-, 6- and 12-months)
- Number of quit attempts(1-, 3-, 6- and 12-months)
- Proportion of smokers visit smoking cessation clinics or call the telephone quitlines(1-, 3-, 6- and 12-months)
研究者
Professor Lam Tai-Hing
Chair Professor
The University of Hong Kong