Title: Feasibility randomised controlled trial of a smoking cessation smartphone app that delivers ‘context aware’ behavioural support in real time
Funder: Department of Health and Social Care

Abstract: The idea for the Quit Sense app came from talking to smokers who were struggling to quit. They wanted help to stop them reaching for a cigarette when they had an urge to smoke. Urges to smoke can happen at any time, most often due to where a person is (e.g. at work) or what they are doing (e.g. socialising). It is not practical to have a person following them around offering advice and support when they get an urge. But as most people own smartphones, we (Cambridge and East Anglia University researchers) decided to use the in-built sensors in smartphones to work out where someone is or what they are doing. These ideas, along with ideas from several members of the public, helped us create Quit Sense, an app that gives smokers trying to quit ‘in the moment’ support to help them avoid or manage urges to smoke._x000D_ _x000D_ Quit Sense works by asking smokers, before they start trying to quit, for information about their_x000D_ surroundings (e.g. home, work) whenever they smoke and how they are feeling (e.g. down, stressed). Each time this happens the app uses the phone’s in-built sensors (e.g. GPS) to record their location. Once smokers start a quit attempt, Quit Sense sends them advice on how to avoid smoking whenever they approach or spend time in a place where they previously told it they had smoked. Quit Sense uses the information the person has given about their surroundings and feelings when they smoke to match advice and support to each location. This is a new approach to help smokers and our pilot studies showed that Quit Sense delivers support as expected and participants like it._x000D_ _x000D_ We want to run a large study to tell us if Quit Sense helps smokers to quit smoking. But first we need to do a smaller study to help us plan for this. The smaller study which we propose will help us design the larger study by telling us how many participants complete a final measure which tells us if they smoke or not; the cost of recruiting participants; whether we can collect information about the costs of Quit Sense if it was used in practice; the number of participants who install and use Quit Sense. Some minor app improvements will also be made. This study will help give us an indication as to whether Quit Sense is likely to help smokers to stop and how it might do this e.g. by boosting confidence. Finding out whether the larger study is possible could save money in the long run and lead to patient benefit by ensuring NHS funding is spent on projects with a good chance of success._x000D_ _x000D_ We will recruit 160 smokers using online adverts on the Google search engine and Facebook. Participants will have an equal chance of being put into one of two groups. A ‘usual care’ group, who will be sent a weblink to the NHS SmokeFree website, providing standard information about NHS help to stop smoking and an App group who will receive the same weblink but will also be given access to the Quit Sense app. Participants will be followed up at 6 weeks and 6 months after they start the study to collect information described above and to compare groups on smoking measures._x000D_ _x000D_ We will publish our findings in journals, present findings at conferences and public events (e.g. Norwich Science Festival), write press releases, communicate with key stakeholders (e.g. Public Health England) and send information to the public and scientific community via social media. If the results are encouraging, we will apply for funding to do a large study to tell us whether or not Quit Sense really does help smokers to quit smoking for good.

Lay abstract: Background_x000D_ Three million UK smokers try to quit each year, but over 80% relapse. Any smoking (lapse) early in a quit attempt is associated with a greatly reduced chance of success. Almost half of lapses are due to cravings brought about by a cue from the environment e.g., from learned associations or the presence of other smokers. Few interventions are effective at targeting cue-induced cravings. Smokers are far less likely to lapse when they use a lapse prevention strategy e.g., using self-talk or avoiding other smokers, to avoid or manage cue-induced cravings but few are skilled in applying these. If smokers trying to quit used effective lapse prevention strategies, this would very likely increase their chances of success. _x000D_ _x000D_ With Patient and Public Involvement (PPI), we developed, refined and piloted a theory-guided smartphone app (Quit Sense, formally known as Q Sense) that provides support to help smokers manage environmental cues to smoke as they arise. The app identifies high-risk situations using a learning tool and location sensing. Two pilot studies have shown that Quit Sense can provide ‘in the moment’ support to smokers, including lapse prevention strategies, and that this is engaged with and is acceptable. The next phase of evaluation is to undertake a feasibility randomised controlled trial (RCT) to inform a definitive effectiveness RCT._x000D_ _x000D_ Research question: Can an RCT of a smoking cessation smartphone app (Quit Sense) be feasibly delivered among an online population of smokers?_x000D_ _x000D_ Aims and objectives_x000D_ 1. Make minor optimisations to Quit Sense to improve the user interface, energy efficiency and method for selecting support message delivery_x000D_ 2. Conduct a feasibility RCT of Quit Sense to inform a definitive effectiveness trial, by estimating:_x000D_ a. Smoking outcome completion_x000D_ b. Usual care arm cessation rate_x000D_ c. Recruitment cost_x000D_ d. Rates of app installation, use and support delivery fidelity_x000D_ e. Completion of health economics-related data_x000D_ f. Participant views of the app (qualitative)_x000D_ g. Intervention effect on smoking behaviour_x000D_ h. Intervention effect on hypothesised mechanisms of action_x000D_ _x000D_ Methods_x000D_ A two arm RCT allocating 160 smokers recruited via online adverts on Google and Facebook to a ‘usual care’ arm (link to NHS SmokeFree website) or a ‘usual care’ plus Quit Sense arm. Enrolment, randomisation and baseline data collection will take place on the study website. Outcomes will be collected at 6 weeks and 6 months follow-up via the study website or telephone, and during app usage. The data will enable us to estimate key feasibility outcomes, the preliminary behavioural impact of Quit Sense, an estimate of cost-effectiveness, in addition to insights on user views of the app through interviews._x000D_ _x000D_ Timeline_x000D_ M1-4: App optimisation and trial set up; M5-20: Recruitment and follow up; M21-24: Analysis, output completion and dissemination_x000D_ _x000D_ Impact and dissemination_x000D_ This trial will produce essential data to inform a definitive trial of Quit Sense which, if effective, could be offered to smokers outside the NHS to help address a key support gap. Quit Sense is highly scalable, could be combined with most other type of cessation support and could be highly cost-effective. Dissemination via presentations, publications, online articles, press releases, social media and public events will be supported by PPI contributors.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: MENTAL HEALTH