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      • Record: found
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      Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial

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          Abstract

          Background

          Adolescence and young adulthood are critical times of initiation and progression to daily use of tobacco. However, it is difficult to recruit young adults to traditional smoking cessation and retention rates are typically low. Smartphone cessation applications (apps) can provide real-time responses to smoking urges and related cues, which are known to be important factors in lapse and relapse. Given the popularity of smartphones among young adults and the considerably higher download rates of commercially developed apps compared to research-based apps, there is a need to design pragmatic studies that evaluate commercial tobacco cessation apps. The aims of this pilot study are to assess the impact on tobacco cessation of using a smartphone app compared with usual care and to generate feasibility data to inform a future fully powered clinical trial.

          Methods

          We will conduct an open randomized controlled trial with parallel groups. Participants will be selected from hospitalized patients and must be aged 18–30 years, interested in cessation, smoked > 5 cigarettes/day over the past 30 days, and own an Apple or Android smartphone. Participants who are eligible will be randomized to either a smartphone experimental group or patient-initiated follow up (usual care). As this study seeks to assess feasibility, the primary data will include (1) recruitment rates, (2) retention rates, and (3) adherence, measured through user engagement with the app.

          Discussion

          This pilot trial will be the first to evaluate a commercially available smartphone app for tobacco cessation in a hospitalized setting. Data generated by this study can be used for larger fully powered trials such as comparative effectiveness studies against apps developed by academics or health scientists based on behavioral theories, or cost-effectiveness analyses of mobile interventions.

          Trial registration

          ClinicalTrials.gov, NCT03538678. Registered on 28 May 2018.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-019-3246-2) contains supplementary material, which is available to authorized users.

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          Most cited references9

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          Recommendations for planning pilot studies in clinical and translational research.

          Charity G. Moore, Rickey E Carter, Paul Nietert … (2011)
          Advances in clinical and translation science are facilitated by building on prior knowledge gained through experimentation and observation. In the context of drug development, preclinical studies are followed by a progression of phase I through phase IV clinical trials. At each step, the study design and statistical strategies are framed around research questions that are prerequisites for the next phase. In other types of biomedical research, pilot studies are used for gathering preliminary support for the next research step. However, the phrase "pilot study" is liberally applied to projects with little or no funding, characteristic of studies with poorly developed research proposals, and usually conducted with no detailed thought of the subsequent study. In this article, we present a rigorous definition of a pilot study, offer recommendations for the design, analysis and sample size justification of pilot studies in clinical and translational research, and emphasize the important role that well-designed pilot studies play in the advancement of science and scientific careers. © 2011 Wiley Periodicals, Inc.
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            Why and how the tobacco industry sells cigarettes to young adults: evidence from industry documents.

            Pamela M Ling, Stanton A. Glantz (2002)
            To improve tobacco control campaigns, we analyzed tobacco industry strategies that encourage young adults (aged 18 to 24) to smoke. Initial searches of tobacco industry documents with keywords (e.g., "young adult") were extended by using names, locations, and dates. Approximately 200 relevant documents were found. Transitions from experimentation to addiction, with adult levels of cigarette consumption, may take years. Tobacco marketing solidifies addiction among young adults. Cigarette advertisements encourage regular smoking and increased consumption by integrating smoking into activities and places where young adults' lives change (e.g., leaving home, college, jobs, the military, bars). Tobacco control efforts should include both adults and youths. Life changes are also opportunities to stop occasional smokers' progress to addiction. Clean air policies in workplaces, the military, bars, colleges, and homes can combat tobacco marketing.
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              Use of smoking-cessation treatments in the United States.

              Sarah E Brockwell, Rian J Pillitteri, Saul Shiffman … (2008)
              Health promotion efforts encourage smokers to quit and to use effective cessation treatments. Randomized controlled trials demonstrate that medications and behavioral treatments improve cessation rates, but retrospective surveys have been inconsistent. This study assessed frequency of quit attempts, use of treatments for cessation, and abstinence rates among treatment users and non-users. Data were analyzed from the 2003 Tobacco Use Special Cessation Supplement to the Current Population Survey. Participants included 29,537 U.S. smokers aged > or =18 years who smoked daily 12 months before the survey. Outcome measures included past-year quit attempts; use of behavioral, pharmacologic, and alternative treatments; receipt of social support; and abstinence for > or =4 weeks at time of survey. Approximately 43.5% of smokers reported a quit attempt in the preceding year: 64.2% of attempters used no cessation treatments; 8.8% used behavioral treatment; 32.2% used medication; and 14.1% used more than one treatment. Social support was reported to have been received by 24.1%. More nicotine-dependent smokers were more likely to use medications (OR=3.58; 95% CI=3.04-4.20). At the time of the survey, 19.3% of attempters were abstinent > or =4 weeks. Smokers who sought treatment were less likely to be abstinent (OR=0.75; 95% CI=0.67-0.84), and those who sought multiple treatments were even less likely to be abstinent. Many U.S. smokers make quit attempts, but most do not use behavioral or pharmacologic treatments. More nicotine-dependent smokers were more likely to seek treatment. Smokers who sought treatment were less likely to report abstinence, probably due to biased self-selection and recall. Retrospective survey data are not well-suited to assess the effectiveness of treatment.
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                Author and article information

                Contributors
                Kar-Hai Chu:
                ORCID: http://orcid.org/0000-0002-2486-8846
                chuk@pitt.edu
                César G. Escobar-Viera: escobar-Viera@pitt.edu
                Sara J. Matheny: sam296@pitt.edu
                Esa M. Davis: davisem@upmc.edu
                Brian A. Primack: bprimack@pitt.edu
                Journal
                Journal ID (nlm-ta): Trials
                Journal ID (iso-abbrev): Trials
                Title: Trials
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1745-6215
                Publication date (Electronic): 26 February 2019
                Publication date PMC-release: 26 February 2019
                Publication date Collection: 2019
                Volume: 20
                Electronic Location Identifier: 147
                Affiliations
                ISNI 0000 0004 1936 9000, GRID grid.21925.3d, University of Pittsburgh, ; 230 McKee Place, Suite 600, Pittsburgh, PA 15213 USA
                Author information
                http://orcid.org/0000-0002-2486-8846
                Article
                Publisher ID: 3246
                DOI: 10.1186/s13063-019-3246-2
                PMC ID: 6390617
                PubMed ID: 30808389
                SO-VID: 80cbed26-ca26-400e-8608-dd17fb18986e
                Copyright © © The Author(s). 2019
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 7 September 2018
                Date accepted : 12 February 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000054, National Cancer Institute;
                Award ID: K07CA222338
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000133, Agency for Healthcare Research and Quality;
                Award ID: K12HS022989
                Categories
                Subject: Study Protocol
                Custom metadata
                issue-copyright-statement © The Author(s) 2019

                ScienceOpen disciplines: Medicine
                Keywords: young adult,smoking cessation,tobacco,smartphone
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: young adult, smoking cessation, tobacco, smartphone

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