The SmokeFree App Smoking Cessation Study

NCT05094583 | Suspended

• 1 other identifier: C&W19/044
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Smoking; Smoking Reduction; Smoking Habit

Keywords

Acute Assessment Unit; Ambulatory Emergency Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• User experience

  12 weeks

• Attrition rate

  12 weeks

• Level of engagement with the SmokeFree app

  12 weeks

Study Arms (2)

Intervention Arm

Patients who expressed wish to quit smoking and accept use of the SmokeFree app

Behavioral: Use of SmokeFree app

Control Arm

Patients who expressed wish to quit smoking but declines all support or use of SmokeFree app

Interventions

Use of SmokeFree app BEHAVIORAL

Intervention Arm

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• \< 18 years
• Patient refusal

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (1)

Chelsea and Westminster Hospital NHS Foundation Trust

London, Lonson, SW10 9NH, United Kingdom

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking; Smoking Reduction

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: October 26, 2021
• Study Start: December 4, 2019
• Primary Completion: December 4, 2021
• Study Completion: December 4, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

GB (1)