Chen Jinsong, Ho Elsie, Jiang Yannan, Whittaker Robyn, Yang Tingzhong, Bullen Christopher
The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.
School of Population Health, The University of Auckland, Auckland, New Zealand.
JMIR Res Protoc. 2020 Sep 18;9(9):e18071. doi: 10.2196/18071.
Approximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking.
This paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period.
A two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app).
Recruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants' 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire).
If the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network-based tool to support Chinese male smokers to quit smoking.
Australian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/18071.
每年约有200万中国人死于与烟草相关的疾病，其中大多数为男性；然而，在中国吸烟者中，接受过任何戒烟建议或支持的人不到8%。基于社交网络的游戏化戒烟干预措施（SCAMPI：中国男性戒烟应用程序：试点干预）旨在帮助中国男性吸烟者戒烟。
本文旨在介绍一项研究方案，通过比较一组用户与对照组在6周随访期内的长期戒烟率，检验SCAMPI的初步效果。
开展双臂试点随机对照试验，以评估SCAMPI项目作为戒烟干预措施的初步效果和可接受性。经过初步的网络筛查，前80名符合条件且完成所需注册流程的个体被登记为试验参与者。参与者被随机分配到干预组（n = 40）和对照组（n = 40）。干预组的参与者使用SCAMPI项目的完整版，该项目是一个基于行为改变轮框架以及相关戒烟和设计指南，并在目标用户参与下开发的中国戒烟项目。该项目提供一系列戒烟方法，包括帮助用户制定戒烟计划、记录戒烟益处的计算器、记录进展的日历、促进戒烟的游戏化、提供吸烟危害信息、帮助用户克服冲动的激励信息、为用户提供评估尼古丁依赖水平和肺部健康的标准化测试，以及提供一个鼓励用户之间社交支持的平台。对照组的参与者使用SCAMPI项目的受限版（安慰剂应用程序）。
该项目于2019年1月开始招募，并持续到2019年3月。随访数据收集于2019年6月开始并完成。该研究的主要结局指标是6周随访时经生物验证的30天戒烟情况（通过尼古丁可替宁唾液测试验证的自我报告数据）。该研究的次要结局指标包括参与者的卷烟消费量减少情况（将基线每日卷烟消费量与试验结束时的每日卷烟消费量进行比较）、参与者在4周和6周随访时的7天戒烟情况（自我报告）、参与者在6周随访时的30天戒烟情况（仅自我报告数据），以及参与者使用SCAMPI项目的可接受性和满意度水平（通过移动应用评分量表问卷进行测量）。
如果SCAMPI项目被证明初步有效，该研究将扩大为未来的试验，样本量更大且随访时间更长（6个月），以确定它是否是一种有效的基于社交网络的工具，支持中国男性吸烟者戒烟。
澳大利亚新西兰临床试验注册中心ACTRN12618001089224；https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381。
国际注册报告识别码（IRRID）：RR1-10.2196/18071。
