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

ABSTRACT: BACKGROUND: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. OBJECTIVE:This initial evaluation of Pivot aimed to assess participant engagement, changes in attitudes toward quitting, and changes in smoking behavior. METHODS: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]). RESULTS: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<.001) and decreased expected difficulty maintaining quit (3.1 to 6.8, P<.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. CONCLUSIONS: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. TRIAL REGISTRATION:ClinicalTrials.gov NCT03295643; https://clinicaltrials.gov/ct2/show/NCT03295643 (Archived by WebCite at http://www.webcitation.org/75TiNe6BE).

SUBMITTER: Marler JD

PROVIDER: S-EPMC6378548 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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

Marler Jennifer D JD Fujii Craig A CA Utley David S DS Tesfamariam Lydia J LJ Galanko Joseph A JA Patrick Heather H

JMIR mHealth and uHealth 20190204 2

<h4>Background</h4>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.<h4>Objective</h4>This ...[more]

PMID: 30670372

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Project description:BackgroundDespite 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.ObjectiveThe 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.MethodsThis 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.ResultsA 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.ConclusionsThis 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.Trial registrationClinicalTrials.gov NCT03295643; https://clinicaltrials.gov/ct2/show/NCT03295643.

Project description:Tobacco smoking is the leading cause of preventable death in the United States, and the annual economic burden attributable to smoking exceeds US $300 billion. Obstacles to smoking cessation include limited access and adherence to effective cessation interventions. Technology can help overcome these obstacles; many smartphone apps have been developed to aid smoking cessation, but few that conform to the US clinical practice guideline (USCPG) have been rigorously tested and reported in the literature. Clickotine is a novel smartphone app for smoking cessation, designed to deliver the essential features of the USCPG and engineered to engage smokers by personalizing intervention components.Our objective was to assess the engagement, efficacy, and safety of Clickotine in an initial, single-arm study. Outcomes measured were indicators of engagement with the smartphone app (number of app opens, number of interactions with the Clickotine program, and weeks active with Clickotine), cessation outcomes of 7- and 30-day self-reported abstinence from smoking, and negative health events.We recruited US residents between 18 and 65 years of age who owned an iPhone and smoked 5 or more cigarettes daily for the study via online advertising. Respondents were prescreened for eligibility by telephone and, if appropriate, directed to a Web portal to provide informed consent, confirm eligibility, and download the Clickotine app. Participants completed study assessments via the online portal at baseline and after 8 weeks. Data were collected in Amazon S3 with no manual data entry, and access to all data was maximally restrictive, logged, and auditable.A total of 416 participants downloaded the app and constituted the intention-to-treat (ITT) sample. On average, participants opened the Clickotine app 100.6 times during the 8-week study (median 69), logged 214.4 interactions with the Clickotine program (median 178), and remained engaged with Clickotine for 5.3 weeks (median 5). Among the ITT sample, 45.2% (188/416) reported 7-day abstinence and 26.2% (109/416) reported 30-day abstinence from smoking after 8 weeks. Completer analysis focused on 365 (87.7%) of the 416 enrolled participants who completed the 8-week questionnaire revealed that 51.5% (188/365) of completers reported 7-day abstinence and 29.9% (109/365) reported 30-day abstinence. Few adverse events, mostly consistent with nicotine withdrawal symptoms, were reported and overall no safety signal was detected.In this initial single-arm trial, Clickotine users appeared to demonstrate encouraging indicators of engagement in terms of the number of app opens, number of program interactions, and continued engagement over time. Clickotine users reported encouraging quit rates while reporting few adverse events. Future research is warranted to assess Clickotine's efficacy in a randomized controlled trial.Clinicaltrials.gov NCT02656745; https://clinicaltrials.gov/ct2/show/NCT02656745 (Archived by WebCite at http://www.webcitation.org/6peTT4x60).

Project description:BackgroundThe number of mobile apps that support smoking cessation is growing, indicating the potential of the mobile phone as a means to support cessation. Knowledge about the potential end users for cessation apps results in suggestions to target potential user groups in a dissemination strategy, leading to a possible increase in the satisfaction and adherence of cessation apps.ObjectiveThis study aimed to characterize potential end users for a specific mobile health (mHealth) smoking cessation app.MethodsA quantitative study was conducted among 955 Dutch smokers and ex-smokers. The respondents were primarily recruited from addiction care facilities and hospitals through Web-based media via websites and forums. The respondents were surveyed on their demographics, smoking behavior, and personal innovativeness. The intention to use and the attitude toward a cessation app were determined on a 5-point Likert scale. To study the association between the characteristics and intention to use and attitude, univariate and multivariate ordinal logistic regression analyses were performed.ResultsThe multivariate ordinal logistic regression showed that the number of previous quit attempts (odds ratio [OR] 4.1, 95% CI 2.4-7.0, and OR 3.5, 95% CI 2.0-5.9) and the score on the Fagerstrom Test of Nicotine Dependence (OR 0.8, 95% CI 0.8-0.9, and OR 0.8, 95% CI 0.8-0.9) positively correlates with the intention to use a cessation app and the attitude toward cessation apps, respectively. Personal innovativeness also positively correlates with the intention to use (OR 0.3, 95% CI 0.2-0.4) and the attitude towards (OR 0.2, 95% CI 0.1-0.4) a cessation app. No associations between demographics and the intention to use or the attitude toward using a cessation app were observed.ConclusionsThis study is among the first to show that demographic characteristics such as age and level of education are not associated with the intention to use and the attitude toward using a cessation app when characteristics related specifically to the app, such as nicotine dependency and the number of quit attempts, are present in a multivariate regression model. This study shows that the use of mHealth apps depends on characteristics related to the content of the app rather than general user characteristics.

Project description:Cigarette smoking is the leading preventable cause of death and is responsible for more than 480,000 deaths per year in the United States. Smoking cessation is challenging for many patients. Regardless of available treatment options, most quit attempts are unaided, and it takes multiple attempts before a patient is successful. With the ever-increasing use of smartphones, mobile apps hold promise in supporting cessation efforts. This study evaluates the ease of use and user satisfaction with the Pfizer Meds app to support smoking cessation among patients prescribed varenicline (Chantix).Study participants included varenicline users who downloaded and used the app on their personal smartphone. The main objectives were to report mobile app download frequency and usage details and to describe the participant-reported satisfaction with and usefulness of the app over the 14-week follow-up study period.Adults aged 18 years or older who had been prescribed varenicline were identified from the Express Scripts Incorporated pharmacy claims database. After meeting privacy restrictions, subjects were sent an invitation letter and second reminder letter with instructions on how to download the Pfizer Meds mobile app. Participants received a push notification to complete a smartphone-enabled survey regarding the utility of the app 12 weeks after downloading the app. Descriptive statistics summarized sociodemographics, use of varenicline, and details of use and satisfaction with the mobile app.Of the 38,129 varenicline users who were sent invitation letters, 1281 participants (3.35%) downloaded the Pfizer Meds app. Of the 1032 users with demographic and other data, 585 (56.68%) were females, and 446 (43.22%) were males; mean age was 46.4 years (SD 10.8). The mean number of app sessions per participant was 4.0 (SD 6.8). The end-of-study survey was completed by 131 survey respondents (10.23%, 131/1281); a large number of participants (117/131, 89.3%) reported being extremely, very, or moderately satisfied with the app. A total of 97 survey respondents (97/131, 74.0%) reported setting up a quit date in the app. Of those, 74 (74/97, 76%) reported quitting on their quit date.Positive patient engagement was observed in this study based on app download and usage. This study quantified how the Pfizer Meds app performed in an observational real-world data setting. The findings demonstrate the willingness of participants to set a quit date and use the app for support in medication adherence, refill reminders, and information regarding how to take the medication. This study provides real-world evidence of the contribution apps can make to the continued encouragement of smokers to improve their health by smoking cessation.

Project description:ObjectiveMobile phone-based interventions have been proven to be effective tools for smoking cessation, at least in the short term. Gamification, that is, the use of game-design elements in a non-game context, has been associated with increased engagement and motivation, critical success factors for long-term success of mobile Health solutions. However, to date, no app review has examined the use of gamification in smoking cessation mobile apps. Our review aims to examine and quantify the use of gamification strategies (broad principles) and tactics (on-screen features) among existing mobile apps for smoking cessation in the UK.MethodsThe UK Android and iOS markets were searched in February 2018 to identify smoking cessation apps. 125 Android and 15 iOS apps were tested independently by two reviewers for primary functionalities, adherence to Five A smoking cessation guidelines, and adoption of gamification strategies and tactics. We examined differences between platforms with χ2 tests. Correlation coefficients were calculated to explore the relationship between adherence to guidelines and gamification.ResultsThe most common functionality of the 140 mobile apps we reviewed allowed users to track the days since/until the quit date (86.4%). The most popular gamification strategy across both platforms was performance feedback (91.4%). The majority of apps adopted a medium level of gamification strategies (55.0%) and tactics (64.3%). Few adopted high levels of gamification strategies (6.4%) or tactics (5.0%). No statistically significant differences between the two platforms were found regarding level of gamification (p>0.05) and weak correlations were found between adherence to Five A's and gamification strategies (r=0.38) and tactics (r=0.26).ConclusionThe findings of this review show that a high level of gamification is adopted by a small minority of smoking cessation apps in the UK. Further exploration of the use of gamification in smoking cessation apps may provide insights into its role in smoking cessation.

Project description:BACKGROUND:Smoking is one of the most significant factors contributing to low life expectancy, health inequalities, and illness at the worldwide scale. Smoking cessation attempts benefit from social support. Mobile phones have changed the way we communicate through the use of freely available message-oriented apps. Mobile app-based interventions for smoking cessation programs can provide interactive, supportive, and individually tailored interventions. OBJECTIVE:This study aimed to identify emotions, coping strategies, beliefs, values, and cognitive evaluations of smokers who are in the process of quitting, and to analyze online social support provided through the analysis of messages posted to a chat function integrated into a mobile app. METHODS:In this descriptive qualitative study, informants were smokers who participated in the chat of Tobbstop. The technique to generate information was documentary through messages collected from September 2014 through June 2016, specifically designed to support a smoking cessation intervention. A thematic content analysis of the messages applied 2 conceptual models: the Lazarus and Folkman model to assess participant's experiences and perceptions and the Cutrona model to evaluate online social support. RESULTS:During the study period, 11,788 text messages were posted to the chat by 101 users. The most frequent messages offered information and emotional support, and all the basic emotions were reported in the chat. The 3 most frequent coping strategies identified were physical activity, different types of treatment such as nicotine replacement, and humor. Beliefs about quitting smoking included the inevitability of weight gain and the notion that not using any type of medications is better for smoking cessation. Health and family were the values more frequently described, followed by freedom. A smoke-free environment was perceived as important to successful smoking cessation. The social support group that was developed with the app offered mainly emotional and informational support. CONCLUSIONS:Our analysis suggests that a chat integrated into a mobile app focused on supporting smoking cessation provides a useful tool for smokers who are in the process of quitting, by offering social support and a space to share concerns, information, or strategies.

Project description:BACKGROUND:Smoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt. OBJECTIVE:We present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group). METHODS:The target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits. RESULTS:Of 548 patients identified using the hospital's electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019. CONCLUSIONS:Social networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking. TRIAL REGISTRATION:ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/record/NCT03553173 (Archived by WebCite at http://www.webcitation.org/74DuHypOW). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/12464.

Dataset Information

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

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

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