Proactive Minimal Cessation Advice Plus Nicotine Replacement Therapy (PMCAN) for Smoking Cessation in Smokers at Smoking Hotspots: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Exhaled CO validated abstinence
研究概览
简要总结
Background: Many smokers cannot quit due to nicotine withdrawal symptoms, which peak at the first week of abstinence. Proactive recruitment of smokers is needed as most smokers do not seek smoking cessation (SC) services. A smoking hotspot (SH) is defined as a public outdoor place where smokers stop/linger and smoke. We aim to include a reasonably "representative" or unbiased sample of SH at different locations from all 3 regions of Hong Kong. We will randomly select 6 eligible SH (2 in each regions) from the 15 hotspots in our previous community trial.
Methods: Two trained SC ambassadors (student helpers) and one supervisor (experienced research assistant) will be deployed for each session of intervention at a SH. Potential subjects will be approached using the "a-foot-into-the-door" method in which SC ambassador will ask if smoker would like to reduce/quit smoking and receive SC intervention or advices. Smokers will be assessed for eligibility and informed written consent will be sought. Subjects will complete a brief self-administered questionnaire (baseline) using tablet. To reduce later hang-ups of telephone interventions or surveys, SC ambassador will save contact number of the trial into subjects' mobile phones.
Discussion: The findings will provide much needed and original evidence to support a main RCT on these new, proactive, simple and low-cost interventions for improving current SC services and policy for smokers who do not actively seek help from SC services in Hong Kong and elsewhere.
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 (Outcomes Assessor)
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
- •Adult smokers aged 18+ who smoke cigarettes daily.
- •Exhaled carbon monoxide (CO) level of 4ppm or above.
- •Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua)
排除标准
- •Smokers who have contraindication for NRT use: severe angina, arrhythmia, myocardia infraction, pregnancy (or intended to become pregnant <6 months) or breastfeeding.
- •Smokers who have psychiatric/psychological diseases or regular psychotropic medications
- •Smokers who are using SC medication, NRT, other SC services or projects.
研究组 & 干预措施
Nicotine Replacement Therapy
This experimental group receives health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
Nicotine Replacement Therapy
This experimental group receives health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.
干预措施: Health warning leaflet (Other)
Minimal Cessation Advice & Nicotine Replacement Therapy
This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
Minimal Cessation Advice & Nicotine Replacement Therapy
This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.
干预措施: Minimal Cessation Advice (MCA) (Behavioral)
Minimal Cessation Advice & Nicotine Replacement Therapy
This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.
干预措施: Health warning leaflet (Other)
Minimal Cessation Advice
This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet.
干预措施: Minimal Cessation Advice (MCA) (Behavioral)
Minimal Cessation Advice
This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet.
干预措施: Health warning leaflet (Other)
Control
This control group receives a health warning leaflet.
干预措施: Health warning leaflet (Other)
结局指标
主要结局
Exhaled CO validated abstinence
时间窗: 3 month
次要结局
- Self-reported past 7-day point prevalence abstinence(3 month)
- Nicotine Replacement Therapy use(3 month)
- Smoking cessation service use(3 month)
研究者
Dr. Wang Man-Ping
Assistant Professor
The University of Hong Kong