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(JITAI) Smoking Cessation Smartphone App: the Quit Sense Feasibility Trial Protocol

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(JITAI) Smoking Cessation Smartphone App: the Quit Sense Feasibility Trial Protocol Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2020-048204 on 26 April 2021. Downloaded from Randomised controlled trial of a just- in- time adaptive intervention (JITAI) smoking cessation smartphone app: the Quit Sense feasibility trial protocol Felix Naughton ,1 Chloë Brown,2 Juliet High,3 Caitlin Notley ,4 Cecilia Mascolo,2 Tim Coleman,5 Garry Barton,4 Lee Shepstone,3 Stephen Sutton,6 A Toby Prevost,7 David Crane,8 Felix Greaves,9 Aimie Hope1 To cite: Naughton F, Brown C, ABSTRACT Strength and limitations of this study High J, et al. Randomised Introduction A lapse (any smoking) early in a smoking controlled trial of a just- in- time cessation attempt is strongly associated with reduced adaptive intervention (JITAI) ► This is the first randomised controlled trial to evalu- success. A substantial proportion of lapses are due to smoking cessation smartphone ate a context- aware just- in- time adaptive interven- app: the Quit Sense feasibility urges to smoke triggered by situational cues. Currently, no tion for smoking cessation. available interventions proactively respond to such cues trial protocol. BMJ Open ► The study will identify key parameters to inform a 2021;11:e048204. doi:10.1136/ in real time. Quit Sense is a theory- guided just-in- time definitive trial and will estimate intervention im- bmjopen-2020-048204 adaptive intervention smartphone app that uses a learning pact on biochemically validated abstinence from tool and smartphone sensing to provide in- the- moment ► Prepublication history and smoking. additional supplemental material tailored support to help smokers manage cue-induced ► Recruitment, enrolment, baseline data collection, al- for this paper are available urges to smoke. The primary aim of this randomised location, intervention delivery and most data collec- online. To view these files, controlled trial (RCT) is to assess the feasibility of tion during follow-up will be fully automated through please visit the journal online delivering a definitive online efficacy trial of Quit Sense. the study website. (http:// dx. doi. org/ 10. 1136/ Methods and analyses A two- arm parallel- group ► There is potential for selection bias due to the re- bmjopen- 2020- 048204). RCT allocating smokers willing to make a quit attempt, quirement for participants to have internet access recruited via online adverts, to usual care (referral to the and an Android smartphone. Received 22 December 2020 http://bmjopen.bmj.com/ Revised 06 March 2021 NHS SmokeFree website) or usual care plus Quit Sense. Accepted 12 March 2021 Randomisation will be stratified by smoking rate (<16 vs ≥16 cigarettes/day) and socioeconomic status (low vs smokers attempting to quit annually, over high). Recruitment, enrolment, baseline data collection, 5 allocation and intervention delivery will be automated 80% relapse within 12 months. through the study website. Outcomes will be collected at Almost half of all lapses (any smoking) 6 weeks and 6 months follow-up via the study website during a quit attempt are attributed to or telephone, and during app usage. The study aims to cravings triggered by environmental or 6 recruit 200 smokers to estimate key feasibility outcomes, situational cues and lapses early in a quit on September 27, 2021 by guest. Protected copyright. the preliminary impact of Quit Sense and potential cost- attempt are highly predictive of longer-term effectiveness, in addition to gaining insights on user views relapse.7–9 However, the most commonly used of the app through qualitative interviews. cessation medications do not alleviate cue- Ethics and dissemination Ethics approval has been induced cravings.10 11 Furthermore, while granted by the Wales NHS Research Ethics Committee smokers are less likely to lapse if they use an 7 (19/WA/0361). The findings will be disseminated to effective cognitive and/or behavioural lapse the public, the funders, relevant practice and policy prevention strategy,10 12 13 few do so.12 14 There representatives and other researchers. is a need for cessation interventions that Trial registration number ISRCTN12326962. effectively support the management of cue- induced cravings. © Author(s) (or their employer(s)) 2021. Re- use Unlike traditional cessation interventions, permitted under CC BY. INTRODUCTION smartphone apps have the advantage of Published by BMJ. Tobacco smoking is the second largest portability and could therefore better assist 1 For numbered affiliations see contributor of disease burden globally and with cue- induced cravings as they occur. 2 end of article. the largest in the UK. While quitting reduces Some mobile phone- based interventions the risk of smoking- related health problems have features specifically aimed at reducing Correspondence to 3 4 Felix Naughton; and improves mental health, the success lapse risk. Such support can be triggered by F. Naughton@ uea. ac. uk rate remains low. Of the three million UK random Ecological Momentary Assessment Naughton F, et al. BMJ Open 2021;11:e048204. doi:10.1136/bmjopen-2020-048204 1 Open access BMJ Open: first published as 10.1136/bmjopen-2020-048204 on 26 April 2021. Downloaded from prompts15 (where the smartphone prompts the user to Participants complete assessment questions); or it can take the form Eligibility criteria of on-demand (ie, user- initiated) requests for craving Participants will be smokers aged 16 years plus; currently support.16 17 However, given the rapid time to lapse after smoke at least seven cigarettes per week; willing to make a craving onset10 and that many on- demand craving tools quit attempt within 14 days of enrolling; have primary use are seldom used beyond a first try,17 18 these kinds of user- of an Android smartphone (version 5.0 and above) and initiated features may still miss many craving episodes. will be resident in England. Participants must not have To address such limitations in current digital support, previously participated in this trial. we developed Quit Sense, a digital intervention which predicts and adapts to smoking risk in real time19 (a just- in- Study setting time adaptive intervention). Quit Sense is a theory-guided Participants will complete screening, consent, base- smoking cessation tool that delivers ‘context-aware’ lapse line and follow-up measures online. This online design prevention support primarily using smartphone location matches the ‘real world’ setting of smartphone app sensing. It has demonstrated feasibility in delivering ‘in uptake. the moment’ support and acceptability among users.20 We are now conducting a feasibility randomised controlled Online recruitment trial (RCT) of Quit Sense to inform the design parame- Recruitment is through paid-for online advertisements ters of a future RCT and to provide estimates of interven- with Google Search and social media (Facebook and tion impact. Instagram), limited to England-based IP addresses and This trial is being conducted during the COVID-19 targeted at Android devices. Advertisements are managed pandemic and as such different contextual variables may by ‘Nativve’,23 specialists in digital marketing for research impact on study participants during their quit attempts study recruitment. To maximise participation rate effi- (eg, self- isolation, remote working) compared with ciency and in accordance with patient and public involve- before the COVID-19 pandemic. Through qualitative ment (PPI) recommendations, different adverts will be interviews and app recorded feedback, this feasibility trial tested using A/B experiments while recruitment is live. will capture participant views of the acceptability of the People clicking on adverts will be directed to the study app and study, including how these are impacted by any website and provided with study information including COVID-19 restrictions. a downloadable ‘Participant Information Sheet’. The screening and consent procedures are online with an e- sig- Objectives nature confirming consent (table 1 and online supple- In this feasibility trial, we aim to estimate: (a) completion mental appendix 2). After completing an online baseline rates for the anticipated primary outcome for a full trial, questionnaire, participants will be randomly allocated to http://bmjopen.bmj.com/ (b) usual care arm cessation rate, (c) cost of recruitment usual care or usual care plus Quit Sense. As described in using online advertising, (d) rates of app installation figure 1 and informed by a prior text message smoking 24 and use, and support delivery fidelity, (e) completion of cessation intervention, we estimate that ~6625 unique smoking cessation-related resource use and quality of life visitors are required to achieve a sample size of 200. (QoL) data, (f) participant views of the app, as part of a The distribution of socioeconomic status (SES) during qualitative process evaluation, (g) intervention effect on recruitment will be monitored. Low SES is defined as indi- anticipated primary outcome and (h) intervention effect viduals with a semiroutine or routine and manual occu- on hypothesised mechanisms of action of app at 6 weeks pation, class 5 in the National Statistics Socio-Economic on September 27, 2021 by guest. Protected copyright. 25 postenrolment. Classification (NS- SEC), or who have never worked or are long- term unemployed. Targeted advertising will be used to increase low SES representation if less than 45% of our sample are categorised as low SES when 35% of the METHODS AND ANALYSIS target sample is reached. Study design A two- arm parallel- group randomised
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