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The SmokeFree App Smoking Cessation Study

The SmokeFree App Smoking Cessation Study

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05094583
Acronym
SMOKEFREE
Enrollment
50
Registered
2021-10-26
Start date
2019-12-04
Completion date
2021-12-04
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Smoking Cessation, Smoking Habit, Smoking Reduction

Keywords

Acute Assessment Unit, Ambulatory Emergency Care

Brief summary

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.

Interventions

BEHAVIORALUse of SmokeFree app

Intervention Arm

Sponsors

Chelsea and Westminster NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Smoking abstinence12 weeksPercentage 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).

Other

MeasureTime frameDescription
User experience12 weeksUser experience - measured with usability survey completed by intervention arm subjects at 12-week follow-up visit.
Attrition rate12 weeksPercentage of patients enrolled in the intervention arm, who complete the full 12 weeks of treatment
Level of engagement with the SmokeFree app12 weeksNumber of log in sessions and average time spent using the SmokeFree app per session

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026