{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T09:09:33Z","timestamp":1784797773956,"version":"3.55.0"},"reference-count":87,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2024,4,1]],"date-time":"2024-04-01T00:00:00Z","timestamp":1711929600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001921","name":"Public Health Research programme","doi-asserted-by":"publisher","award":["17\/92\/31"],"award-info":[{"award-number":["17\/92\/31"]}],"id":[{"id":"10.13039\/501100001921","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title>\n<jats:p>During a quit attempt, cues from a smoker\u2019s environment are a major cause of brief smoking lapses, which increase the risk of relapse. Quit Sense is a theory-guided Just-In-Time Adaptive Intervention smartphone app, providing smokers with the means to learn about their environmental smoking cues and provides \u2018in the moment\u2019 support to help them manage these during a quit attempt.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-2\"><jats:title>Objective<\/jats:title>\n<jats:p>To undertake a feasibility randomised controlled trial to estimate key parameters to inform a definitive randomised controlled trial of Quit Sense.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title>\n<jats:p>A parallel, two-arm randomised controlled trial with a qualitative process evaluation and a \u2018Study Within A Trial\u2019 evaluating incentives on attrition. The research team were blind to allocation except for the study statistician, database developers and lead researcher. Participants were not blind to allocation.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title>\n<jats:p>Online with recruitment, enrolment, randomisation and data collection (excluding manual telephone follow-up) automated through the study website.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title>\n<jats:p>Smokers (323 screened, 297 eligible, 209 enrolled) recruited via online adverts on Google search, Facebook and Instagram.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title>\n<jats:p>Participants were allocated to \u2018usual care\u2019 arm (<jats:italic>n<\/jats:italic>\u2005=\u2005105; text message referral to the National Health Service SmokeFree website) or \u2018usual care\u2019 plus Quit Sense (<jats:italic>n<\/jats:italic>\u2005=\u2005104), via a text message invitation to install the Quit Sense app.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-7\"><jats:title>Main outcome measures<\/jats:title>\n<jats:p>Follow-up at 6 weeks and 6 months post enrolment was undertaken by automated text messages with an online questionnaire link and, for non-responders, by telephone. Definitive trial progression criteria were met if a priori thresholds were included in or lower than the 95% confidence interval of the estimate. Measures included health economic and outcome data completion rates (progression criterion #1 threshold: \u2265\u200970%), including biochemical validation rates (progression criterion #2 threshold: \u2265\u200970%), recruitment costs, app installation (progression criterion #3 threshold: \u2265\u200970%) and engagement rates (progression criterion #4 threshold: \u2265\u200960%), biochemically verified 6-month abstinence and hypothesised mechanisms of action and participant views of the app (qualitative).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title>\n<jats:p>Self-reported smoking outcome completion rates were 77% (95% confidence interval 71% to 82%) and health economic data (resource use and quality of life) 70% (95% CI 64% to 77%) at 6 months. Return rate of viable saliva samples for abstinence verification was 39% (95% CI 24% to 54%). The per-participant recruitment cost was \u00a319.20, which included advert (\u00a35.82) and running costs (\u00a313.38). In the Quit Sense arm, 75% (95% CI 67% to 83%; 78\/104) installed the app and, of these, 100% set a quit date within the app and 51% engaged with it for more than 1 week. The rate of 6-month biochemically verified sustained abstinence, which we anticipated would be used as a primary outcome in a future study, was 11.5% (12\/104) in the Quit Sense arm and 2.9% (3\/105) in the usual care arm (estimated effect size: adjusted odds ratio\u2005=\u20054.57, 95% CIs 1.23 to 16.94). There was no evidence of between-arm differences in hypothesised mechanisms of action. Three out of four progression criteria were met.<\/jats:p>\n<jats:p>The Study Within A Trial analysis found a \u00a320 versus \u00a310 incentive did not significantly increase follow-up rates though reduced the need for manual follow-up and increased response speed. The process evaluation identified several potential pathways to abstinence for Quit Sense, factors which led to disengagement with the app, and app improvement suggestions.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-9\"><jats:title>Limitations<\/jats:title>\n<jats:p>Biochemical validation rates were lower than anticipated and imbalanced between arms. COVID-19-related restrictions likely limited opportunities for Quit Sense to provide location tailored support.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-10\"><jats:title>Conclusions<\/jats:title>\n<jats:p>The trial design and procedures demonstrated feasibility and evidence was generated supporting the efficacy potential of Quit Sense.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-11\"><jats:title>Future work<\/jats:title>\n<jats:p>Progression to a definitive trial is warranted providing improved biochemical validation rates.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-12\"><jats:title>Trial registration<\/jats:title>\n<jats:p>This trial is registered as ISRCTN12326962.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-13\"><jats:title>Funding<\/jats:title>\n<jats:p>This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 17\/92\/31) and is published in full in <jats:italic>Public Health Research<\/jats:italic>; Vol. 12, No. 4. See the NIHR Funding and Awards website for further award information.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/kqyt5412","type":"journal-article","created":{"date-parts":[[2024,4,27]],"date-time":"2024-04-27T07:59:34Z","timestamp":1714204774000},"page":"1-99","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["A smoking cessation smartphone app that delivers real-time \u2018context aware\u2019 behavioural support: the Quit Sense feasibility RCT"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9790-2796","authenticated-orcid":true,"given":"Felix","family":"Naughton","sequence":"first","affiliation":[{"name":"Behavioural and Implementation Science Group, School of Health Sciences, University of East Anglia, Norwich, 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