The SmokeFree App Smoking Cessation Study

Study Overview
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Brief Summary
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SmokeFree is a theory-driven and evidence-based stop smoking mobile application. Based on NICE guidance and best practice for smoking cessation, the application employs over 30 behaviour change techniques used in NHS Stop Smoking Services. It has been downloaded over 4 million times and has an average user rating of 4.7 out of 5, from over 120,000 ratings. Whilst user feedback has been highly positive, there is a need for further objective studies to demonstrate its efficacy. This is a prospective, observational, two arm feasibility study, which aims to evaluate the efficacy, attrition rate and user experience of the SmokeFree App. Inpatients in the Acute Medical Unit and ambulatory emergency care unit at Chelsea and Westminster Hospital who are current smokers will be offered to participate in the study, in addition to all other smoking cessation interventions, which will also be offered to them. Care will be taken to ensure that all available options of smoking cessation support are offered in addition to the SmokeFree application. Subjects agreeing to participate will be given access to the application for a period of 12 weeks, with a target quit date no later than week 8 of use of the application. At the end of 12 weeks they will be offered a follow up appointment in a purposely designed clinic, where their CO level will be measured, as well as being invited to complete feedback questionnaires on their experience. The primary end point of the study will be the quit rate for a period of minimum of 4 weeks by the completion of the 12 week trial. This will be confirmed with exhaled carbon monoxide testing. Secondary endpoints include user experience, engagement with the mobile application and attrition rate.

Official Title
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The SmokeFree App Smoking Cessation Study

Conditions
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Smoking Cessation, Smoking, Smoking Reduction, Smoking Habit

Intervention / Treatment
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* Behavioral: Use of SmokeFree app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intervention: ≥ 18 years All new patients admitted via the Acute medical via AAU (or AEC) Current smoker and willing to quit Smartphone owner Fluent in English (verbal and written) Able to give informed consent Able and willing to attend a follow up visit in 12 weeks. Control: - Meet above inclusion criteria except ownership of smartphone. Exclusion Criteria: < 18 years Patient refusal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention Arm<br>Patients who expressed wish to quit smoking and accept use of the SmokeFree app | Behavioral: Use of SmokeFree app<br>* Intervention Arm<br>|
| Control Arm<br>Patients who expressed wish to quit smoking but declines all support or use of SmokeFree app | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence | Percentage of participants who achieved sustained abstinence over 4 weeks, within 12 weeks from starting to use the SmokeFree app, compared against outcomes for patients who expressed wish to quit but declined use of the SmokeFree app (This will be confirmed with CO testing at 12-week follow-up visit). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Assessment Unit, Ambulatory Emergency Care