■在尝试退出时,来自吸烟者环境的提示是短暂吸烟失误的主要原因,这增加了复发的风险。QuitSense是一款理论指导的即时自适应干预智能手机应用程序,为吸烟者提供了解其环境吸烟线索的手段,并提供“此刻”支持,以帮助他们在戒烟尝试中管理这些线索。
■进行可行性随机对照试验,以估计关键参数,从而为最终的QuitSense随机对照试验提供信息。
■A并行,双臂随机对照试验,采用定性过程评估和“试验中的研究”评估减员激励措施。除了研究统计人员之外,研究小组对分配视而不见,数据库开发人员和首席研究员。参与者对分配并不盲目。
■在线招聘,注册,通过研究网站自动进行随机分组和数据收集(不包括人工电话随访)。
■吸烟者(323筛选,297合格,209注册)通过谷歌搜索的在线广告招募,Facebook和Instagram。
■参与者被分配到“常规护理”手臂(n=105;短信转介给国家卫生服务无烟网站)或“常规护理”加上退出感(n=104),通过短信邀请安装QuitSense应用程序。
■在注册后6周和6个月通过带有在线问卷链接的自动短信进行随访,对于非响应者,通过电话。如果先验阈值包含在或低于估计值的95%置信区间,则满足最终的试验进展标准。措施包括卫生经济和结果数据完成率(进展标准#1阈值:≥70%),包括生化验证率(进展标准#2阈值:≥70%),招聘费用,应用程序安装(进度标准#3阈值:≥70%)和参与率(进度标准#4阈值:≥60%),生化验证6个月的禁欲和假设的作用机制和参与者对应用程序的看法(定性)。
■6个月时,自我报告的吸烟结局完成率为77%(95%置信区间71%至82%),健康经济数据(资源使用和生活质量)为70%(95%CI64%至77%)。用于禁欲验证的可行唾液样本的回报率为39%(95%CI24%至54%)。每位参与者的招聘费用为19.20英镑,其中包括广告(5.82英镑)和运行费用(13.38英镑)。在退出感知臂中,75%(95%CI67%至83%;78/104)安装了该应用程序,其中,100%在应用程序中设置退出日期,51%的人参与超过1周。6个月生化验证的持续禁欲率,我们预计这将作为未来研究的主要结果,在QuitSense组中为11.5%(12/104),在常规护理组中为2.9%(3/105)(估计效应大小:调整后比值比=4.57,95%CI=1.23~16.94)。没有证据表明假设的作用机制在手臂之间存在差异。符合四个进展标准中的三个。试验分析发现,20英镑与10英镑的激励措施并没有显着提高随访率,尽管减少了手动随访的需要并提高了响应速度。过程评估确定了几种可能的戒烟途径,导致与应用程序脱离接触的因素,和应用程序改进建议。
■生化验证率低于预期,并且手臂之间不平衡。与COVID-19相关的限制可能限制了QuitSense提供位置定制支持的机会。
■试验设计和程序证明了可行性,并产生了支持QuitSense疗效潜力的证据。
■有必要进行确定性试验,以提高生化验证率。
■本试验注册为ISRCTN12326962。
■该奖项由美国国家卫生与护理研究所(NIHR)公共卫生研究计划(NIHR奖ref:17/92/31)资助,并在《公共卫生研究》中全文发表。12号4.有关更多奖项信息,请参阅NIHR资助和奖励网站。
吸烟者通常由于周围环境(例如在吸烟者周围)引发的吸烟冲动而无法戒烟。我们开发了一个智能手机应用程序(“QuitSense”),可以了解个人的周围环境和吸烟位置。在尝试戒烟时,QuitSense使用内置传感器来识别吸烟者何时在这些位置,并发送“即时”建议,以帮助防止他们吸烟。我们进行了一项可行性研究,以帮助计划未来的大型研究,以了解QuitSense是否可以帮助吸烟者戒烟。这项可行性研究旨在告诉我们有多少参与者完成研究措施;招聘成本;有多少参与者安装和使用QuitSense;并估计QuitSense是否可以帮助吸烟者戒烟以及如何做到这一点。我们在Google搜索中使用在线广告招募了209名吸烟者,Facebook和Instagram,每位参与者花费£19。然后,参与者有相等的机会收到指向国家卫生服务SmokeFree网站(“常规护理组”)的网络链接,或者收到相同的网络链接以及指向QuitSense应用程序(“QuitSense组”)的链接。四分之三的QuitSense小组在手机上安装了该应用程序,其中一半使用该应用程序超过1周。我们在6个月时对77%的参与者进行了随访,以收集研究数据,尽管只有39%的戒烟者返回了唾液样本进行禁欲验证。6个月时,与常规护理组(3%)相比,QuitSense组戒烟人数更多(12%).目前尚不清楚该应用程序如何根据研究措施帮助吸烟者戒烟,尽管采访发现,培训该应用程序的过程帮助人们通过了解引发吸烟行为的原因来戒烟。研究结果支持进行一项大型研究,以告诉我们QuitSense是否真的帮助吸烟者戒烟。
UNASSIGNED: During a quit attempt, cues from a smoker\'s environment are a major cause of brief smoking lapses, which increase the risk of relapse. Quit Sense is a theory-guided Just-In-Time Adaptive Intervention smartphone app, providing smokers with the means to learn about their environmental smoking cues and provides \'in the moment\' support to help them manage these during a quit attempt.
UNASSIGNED: To undertake a feasibility randomised controlled trial to estimate key parameters to inform a definitive randomised controlled trial of Quit Sense.
UNASSIGNED: A parallel, two-arm randomised controlled trial with a qualitative process evaluation and a \'Study Within A Trial\' evaluating incentives on attrition. The research team were blind to allocation except for the study statistician, database developers and lead researcher. Participants were not blind to allocation.
UNASSIGNED: Online with recruitment, enrolment, randomisation and data collection (excluding manual telephone follow-up) automated through the study website.
UNASSIGNED: Smokers (323 screened, 297 eligible, 209 enrolled) recruited via online adverts on Google search, Facebook and Instagram.
UNASSIGNED: Participants were allocated to \'usual care\' arm (n = 105; text message referral to the National Health Service SmokeFree website) or \'usual care\' plus Quit Sense (n = 104), via a text message invitation to install the Quit Sense app.
UNASSIGNED: Follow-up at 6 weeks and 6 months post enrolment was undertaken by automated text messages with an online questionnaire link and, for non-responders, by telephone. Definitive trial progression criteria were met if a priori thresholds were included in or lower than the 95% confidence interval of the estimate. Measures included health economic and outcome data completion rates (progression criterion #1 threshold: ≥ 70%), including biochemical validation rates (progression criterion #2 threshold: ≥ 70%), recruitment costs, app installation (progression criterion #3 threshold: ≥ 70%) and engagement rates (progression criterion #4 threshold: ≥ 60%), biochemically verified 6-month abstinence and hypothesised mechanisms of action and participant views of the app (qualitative).
UNASSIGNED: Self-reported smoking outcome completion rates were 77% (95% confidence interval 71% to 82%) and health economic data (resource use and quality of life) 70% (95% CI 64% to 77%) at 6 months. Return rate of viable saliva samples for abstinence verification was 39% (95% CI 24% to 54%). The per-participant recruitment cost was £19.20, which included advert (£5.82) and running costs (£13.38). In the Quit Sense arm, 75% (95% CI 67% to 83%; 78/104) installed the app and, of these, 100% set a quit date within the app and 51% engaged with it for more than 1 week. The rate of 6-month biochemically verified sustained abstinence, which we anticipated would be used as a primary outcome in a future study, was 11.5% (12/104) in the Quit Sense arm and 2.9% (3/105) in the usual care arm (estimated effect size: adjusted odds ratio = 4.57, 95% CIs 1.23 to 16.94). There was no evidence of between-arm differences in hypothesised mechanisms of action. Three out of four progression criteria were met. The Study Within A Trial analysis found a £20 versus £10 incentive did not significantly increase follow-up rates though reduced the need for manual follow-up and increased response speed. The process evaluation identified several potential pathways to abstinence for Quit Sense, factors which led to disengagement with the app, and app improvement suggestions.
UNASSIGNED: Biochemical validation rates were lower than anticipated and imbalanced between arms. COVID-19-related restrictions likely limited opportunities for Quit Sense to provide location tailored support.
UNASSIGNED: The trial design and procedures demonstrated feasibility and evidence was generated supporting the efficacy potential of Quit Sense.
UNASSIGNED: Progression to a definitive trial is warranted providing improved biochemical validation rates.
UNASSIGNED: This trial is registered as ISRCTN12326962.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 17/92/31) and is published in full in Public Health Research; Vol. 12, No. 4. See the NIHR Funding and Awards website for further award information.
Smokers often fail to quit because of urges to smoke triggered by their surroundings (e.g. being around smokers). We developed a smartphone app (‘Quit Sense’) which learns about an individual’s surroundings and locations where they smoke. During a quit attempt, Quit Sense uses in-built sensors to identify when smokers are in those locations and sends ‘in the moment’ advice to help prevent them from smoking. We ran a feasibility study to help plan for a future large study to see if Quit Sense helps smokers to quit. This feasibility study was designed to tell us how many participants complete study measures; recruitment costs; how many participants install and use Quit Sense; and estimate whether Quit Sense may help smokers to stop and how it might do this. We recruited 209 smokers using online adverts on Google search, Facebook and Instagram, costing £19 per participant. Participants then had an equal chance of receiving a web link to the National Health Service SmokeFree website (‘usual care group’) or receive that same web link plus a link to the Quit Sense app (‘Quit Sense group’). Three-quarters of the Quit Sense group installed the app on their phone and half of these used the app for more than 1 week. We followed up 77% of participants at 6 months to collect study data, though only 39% of quitters returned a saliva sample for abstinence verification. At 6 months, more people in the Quit Sense group had stopped smoking (12%) than the usual care group (3%). It was not clear how the app helped smokers to quit based on study measures, though interviews found that the process of training the app helped people quit through learning about what triggered their smoking behaviour. The findings support undertaking a large study to tell us whether Quit Sense really does help smokers to quit.