Marler Jennifer D, Fujii Craig A, Galanko Joseph A, Balbierz Daniel J, Utley David S
Carrot Inc., Redwood City, CA, United States.
Biostatistics Core for the Center for Gastrointestinal Biology and Disease and the Clinical Nutrition Research Center, Department of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
J Med Internet Res. 2021 Feb 15;23(2):e25578. doi: 10.2196/25578.
Despite decreasing prevalence over the last several decades, cigarette smoking remains the leading cause of preventable death and disease, underscoring the need for innovative, effective solutions. Pivot is a novel, inclusive smoking cessation program designed for smokers along the entire spectrum of readiness to quit. Pivot leverages proven methods and technological advancements, including a personal portable breath carbon monoxide sensor, smartphone app, and in-app text-based coaching. We previously reported outcomes from the end of active Pivot program participation in 319 adult smokers. Herein, we report longer-term follow up in this cohort.
The aim of this study was to assess and report participant outcomes 3 months after completion of Pivot, including smoking behavior, quit rates, continuous abstinence rates and durability, and predictors of abstinence.
This prospective remote cohort study included US-based cigarette smokers aged 18 to 65 years who smoked ≥5 cigarettes per day (CPD). Three months after completion of active participation in Pivot, final follow-up data were collected via an online questionnaire. Outcomes included smoking behavior (CPD and quit attempts), self-reported quit rates (7- and 30-day point prevalence abstinence [PPA]), and continuous abstinence rates (proportion who achieved uninterrupted abstinence) and duration. Exploratory regression analyses were performed to identify baseline characteristics associated with achievement of 7-day PPA, 30-day PPA, and continuous abstinence.
A total of 319 participants completed onboarding (intention-to-treat [ITT]); 288/319 participants (90.3%) completed follow up (completers) at a mean of 7.2 (SD 1.2) months after onboarding. At final follow up, CPD were reduced by 52.6% (SE 2.1; P<.001) among all 319 participants, and most completers (152/288, 52.8%) reduced their CPD by at least 50%. Overall, most completers (232/288, 80.6%) made at least one quit attempt. Quit rates increased after the end of Pivot; using ITT analyses, 35.4% (113/319) achieved 7-day PPA and 31.3% (100/319) achieved 30-day PPA at final follow up compared with 32.0% (102/319) and 27.6% (88/319), respectively, at the end of the Pivot program. Continuous abstinence was achieved in about a quarter of those who onboarded (76/319, 23.8%) and in most who reported 30-day PPA at the end of Pivot (76/88, 86.4%), with a mean abstinence duration of 5.8 (SD 0.6) months. In exploratory regression analyses, lower baseline CPD, more positive baseline attitudes reflecting higher self-efficacy (higher confidence to quit and lower perceived difficulty of quitting), and higher education were associated with achieving abstinence.
This study provides the first longer-term outcomes of the Pivot smoking cessation program. At final follow up, quit rates increased and continuous abstinence was favorable; the majority who achieved abstinence at the end of Pivot sustained abstinence throughout follow up. Decreases in CPD persisted and most participants made a quit attempt. Overall, final follow-up outcomes were stable or improved when compared to previous outcomes from the end of the program. These findings validate earlier results, and suggest that Pivot is an effective and durable solution for smoking cessation.
ClinicalTrials.gov NCT03295643; https://clinicaltrials.gov/ct2/show/NCT03295643.
尽管在过去几十年中吸烟率有所下降,但吸烟仍然是可预防死亡和疾病的主要原因,这凸显了对创新、有效解决方案的需求。Pivot是一项新颖、全面的戒烟计划,专为处于戒烟准备各个阶段的吸烟者设计。Pivot利用了经过验证的方法和技术进步,包括个人便携式呼气一氧化碳传感器、智能手机应用程序以及应用程序内基于文本的指导。我们之前报告了319名成年吸烟者完成Pivot计划积极参与阶段后的结果。在此,我们报告该队列的长期随访情况。
本研究的目的是评估并报告完成Pivot计划3个月后的参与者结果,包括吸烟行为、戒烟率、持续戒烟率及持久性,以及戒烟的预测因素。
这项前瞻性远程队列研究纳入了年龄在18至65岁、每天吸烟≥5支(CPD)的美国吸烟者。在完成Pivot计划的积极参与3个月后,通过在线问卷收集最终随访数据。结果包括吸烟行为(CPD和戒烟尝试)、自我报告的戒烟率(7天和30天的点患病率戒烟率[PPA])、持续戒烟率(实现不间断戒烟的比例)及持续时间。进行探索性回归分析以确定与实现7天PPA、30天PPA和持续戒烟相关的基线特征。
共有319名参与者完成了入组(意向性分析[ITT]);288/319名参与者(90.3%)在入组后平均7.2(标准差1.2)个月完成了随访(完成者)。在最终随访时,所有319名参与者的CPD降低了52.6%(标准误2.1;P<.001),大多数完成者(152/288,52.8%)的CPD降低了至少50%。总体而言,大多数完成者(232/288,80.6%)至少尝试了一次戒烟。Pivot计划结束后戒烟率有所上升;使用ITT分析,在最终随访时,35.4%(113/319)的参与者实现了7天PPA,31.3%(100/319)的参与者实现了30天PPA,而在Pivot计划结束时,这两个比例分别为32.0%(102/319)和27.6%(88/319)。约四分之一的入组者(76/319,23.8%)实现了持续戒烟,且大多数在Pivot计划结束时报告30天PPA的参与者(76/88,86.4%)实现了持续戒烟,平均戒烟持续时间为5.8(标准差0.6)个月。在探索性回归分析中,较低的基线CPD、反映较高自我效能的更积极基线态度(更高的戒烟信心和更低的感知戒烟难度)以及更高的教育程度与实现戒烟相关。
本研究提供了Pivot戒烟计划的首个长期结果。在最终随访时,戒烟率上升且持续戒烟情况良好;大多数在Pivot计划结束时实现戒烟的参与者在整个随访期间保持了戒烟状态。CPD持续下降,大多数参与者进行了戒烟尝试。总体而言,与该计划结束时的先前结果相比,最终随访结果稳定或有所改善。这些发现验证了早期结果,并表明Pivot是一种有效且持久的戒烟解决方案。
ClinicalTrials.gov NCT03295643;https://clinicaltrials.gov/ct2/show/NCT03295643