The SmokeFree App Smoking Cessation Study

Smoking Cessation Clinical Trial

— SMOKEFREE  

Official title:

The SmokeFree App Smoking Cessation Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05094583
• Other study ID #: C&W19/044
• Status: Suspended
• Start date: December 4, 2019
• Est. completion date: December 4, 2021

Study information

• Verified date: October 2021
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: December 4, 2021
• Est. primary completion date: December 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation
• Smoking Habit
• Smoking Reduction

Intervention

Behavioral:
• Use of SmokeFree app
Intervention Arm

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust	London	Lonson

Sponsors (1)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User experience	User experience - measured with usability survey completed by intervention arm subjects at 12-week follow-up visit.	12 weeks
Other	Attrition rate	Percentage of patients enrolled in the intervention arm, who complete the full 12 weeks of treatment	12 weeks
Other	Level of engagement with the SmokeFree app	Number of log in sessions and average time spent using the SmokeFree app per session	12 weeks
Primary	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