Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study (Preprint) (2018)

<sec> <title>BACKGROUND</title> Cigarette smoking is the leading cause of preventable morbidity and mortality, excess health care expenditure, and lost work productivity. Otherwise effective evidence-based treatments have had limited success owing to challenges with access, engagement, and scale. Pivot is a comprehensive digital smoking cessation program that incorporates a Food and Drug Administration–cleared carbon monoxide breath sensor, smartphone app, and text-based human coaching. </sec> <sec> <title>OBJECTIVE</title> This initial evaluation of Pivot aimed to assess participant engagement, changes in attitudes toward quitting, and changes in smoking behavior. </sec> <sec> <title>METHODS</title> US cigarette smokers aged 18 to 65 years who smoked ≥5 cigarettes per day (CPD) were recruited online. Participants completed a screening call, electronic informed consent, registration, and onboarding before beginning Pivot. Pivot includes 5 sequential stages (Explore, Build, Mobilize, Quit, and Secure), taking 14.5 to 18.5 weeks to complete. Data were collected via app and online questionnaires. Outcomes included engagement and retention (ie, weeks of active engagement and Pivot stage progression); attitudes toward quitting (ie, quit readiness, quit confidence, and expected difficulty maintaining quit); and smoking behavior (ie, quit attempts, cigarette reduction, and abstinence (7- and 30-day point prevalence abstinence [PPA]). </sec> <sec> <title>RESULTS</title> A total of 319 participants completed onboarding (intention-to-treat [ITT] sample); 272/319 participants (85.3%) completed the end-of-Pivot questionnaire (study completer sample). Most (212/319, 66.5%) were not ready to quit in the next 30 days at baseline. On average, participants actively engaged in the program for a mean 12.4 (SD 7.1) weeks. Pivot stage completion rates were Explore: 88.7% (283/319), Build: 57.4% (183/319), Mobilize: 43.6% (139/319), Quit: 41.1% (131/319), and Secure: 39.5% (126/319). Repeated measures linear mixed model analyses demonstrated positive changes in attitudes from baseline to Mobilize (pre-Quit): increased confidence to quit (4.2 to 7.4, P&lt;.001) and decreased expected difficulty maintaining quit (3.1 to 6.8, P&lt;.001). The quit attempt rate (ie, those making ≥1 quit attempt lasting ≥1 day) was 79.4% (216/272, completer). At the end of Pivot, 7-day PPA rates were 32.0% (102/319, ITT) and 37.5% (102/272, completer); 30-day PPA rates were 27.6% (88/319, ITT) and 32.4% (88/272, completer). Moreover, 30-day PPA rates were comparable among those ready and not ready to quit in the next 30 days at baseline. Of those not achieving abstinence, 25.9% (44/170, completer) achieved ≥50% reduction in CPD by study end. </sec> <sec> <title>CONCLUSIONS</title> This study evaluated Pivot’s initial performance with comparable quit rates among those ready and not ready to quit in the next 30 days at entry. The present data, considered with the program’s accessibility, innovation, evidence-based foundation, and design for all smokers, suggest Pivot has the potential to address limitations of reach and scale and thereby advance smoking cessation efforts. </sec> <sec> <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT03295643; https://clinicaltrials.gov/ct2/show/NCT03295643 (Archived by WebCite at http://www.webcitation.org/75TiNe6BE). </sec>