School of Nursing, University of Hong Kong, 4/F, William MW Block, 21 Sassoon Road, Pokfulam, Hong Kong SAR.
Department of Psychiatry, University of Hong Kong, 2/F, New Clinical Building, Queen Mary Hospital, 102 Pokfulam Road, Pokfulam, Hong Kong SAR.
BMC Public Health. 2018 Jul 4;18(1):830. doi: 10.1186/s12889-018-5782-1.
Actively referring smokers to smoking cessation (SC) services could increase quitting and is scalable for the population. The objective of this study is to compare 2 different intensities of SC active referral for smokers in the community of Hong Kong.
METHODS/DESIGN: This is a single-blind, parallel 3-armed cluster randomized controlled trial (cRCT) consisting of high-intensity SC active referral (HAR Group), low-intensity SC referral by text messaging on promoting SC services use (Text Group) and a control group receives general very brief advice. Biochemically validated daily smokers will be proactively recruited in the community from 68 clusters (recruitment sessions). The primary outcome is self-reported 7-days point prevalence abstinence (PPA) at the 3- and 6- month follow-ups. Secondary outcomes are SC service use, smoking reduction rate (SRR, daily cigarette consumption reduced by ≥50%; excluding quitters) and biochemically validated quit rate (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml). Outcome assessors and data analysts will be blinded to group allocation. Intention-to-treat principle and Generalized Estimating Equation (GEE) regressions will be used for data analysis.
This will be the first trial on evaluating the efficacy of the 2 different intensities of SC active referral on smoking cessation in community smokers. It is anticipated that the results from this trial can provide evidence to the effectiveness of high-intensity active referral to SC services and low intensity SC referral by using text messaging in achieving smoking abstinence.
ClinicalTrials.gov Identifier: NCT02804880 , June 17, 2016.
积极向吸烟者推荐戒烟（SC）服务可以提高戒烟率，并且可以在人群中推广。本研究的目的是比较香港社区中两种不同强度的 SC 主动转介对吸烟者的影响。
方法/设计：这是一项单盲、平行 3 臂聚类随机对照试验（cRCT），包括高强度 SC 主动转介（HAR 组）、通过短信促进 SC 服务使用的低强度 SC 转介（短信组）和对照组接受一般的非常简短的建议。将在社区从 68 个群集中（招募会议）主动招募生物化学验证的每日吸烟者。主要结局是在 3 个月和 6 个月随访时自我报告的 7 天点患病率（PPA）。次要结局是 SC 服务使用、吸烟减少率（SRR，每日吸烟量减少≥50%；不包括戒烟者）和生物化学验证的戒烟率（呼气 CO < 4 ppm 和唾液可替宁 < 10 ng/ml）。结局评估者和数据分析师将对分组分配保持盲态。意向治疗原则和广义估计方程（GEE）回归将用于数据分析。
这将是第一个评估两种不同强度 SC 主动转介对社区吸烟者戒烟效果的试验。预计该试验的结果可以为高强度主动转介 SC 服务和使用短信进行低强度 SC 转介实现戒烟的有效性提供证据。
ClinicalTrials.gov 标识符：NCT02804880，2016 年 6 月 17 日。
