The SmokeFree App Smoking Cessation Study (SMOKEFREE)

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.

Study Overview

• Status: Suspended
• Conditions: Smoking; Smoking Cessation; Smoking Reduction; Smoking Habit
• Intervention / Treatment: Behavioral: Use of SmokeFree app

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United Kingdom
  • Lonson
    • London, Lonson, United Kingdom, SW10 9NH
      • Chelsea And Westminster Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention Arm; Patients who expressed wish to quit smoking and accept use of the SmokeFree app	Behavioral: Use of SmokeFree app; Intervention Arm
Control Arm; Patients who expressed wish to quit smoking but declines all support or use of SmokeFree app

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chelsea and Westminster NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 4, 2019
• Primary Completion (ANTICIPATED): December 4, 2021
• Study Completion (ANTICIPATED): December 4, 2021

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (ACTUAL): October 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Acute Assessment Unit; Ambulatory Emergency Care
• Other Study ID Numbers: C&W19/044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No