Clinical trial NCT05094583: The SmokeFree App Smoking Cessation Study
Official title: The SmokeFree App Smoking Cessation Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Smoking Cessation
Smoking
Smoking Reduction
Smoking Habit
Keywords: Acute Assessment Unit
Ambulatory Emergency Care
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study participant will be recruited from the Acute Assessment Unit and Ambulatory Emergency Care at Chelsea and Westminster Hospital.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Smoking abstinence
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: User experience
timeFrame: 12 weeks
measure: Attrition rate
timeFrame: 12 weeks
measure: Level of engagement with the SmokeFree app
timeFrame: 12 weeks
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
state: Lonson
Study officials:
References: