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Suspended due to COVID19 pandemic.
SMOKEFREE
Sponsor study identifier
observational
50
1 country
1
Study Start
December 4, 2019
Actual (reported)Primary Completion
December 4, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 4, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 4, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 4, 2019
Actual (reported)February 9, 2021
Actual (reported)October 26, 2021
Actual (reported)December 4, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 4, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
User experience
12 weeks
Attrition rate
12 weeks
Patients who expressed wish to quit smoking and accept use of the SmokeFree app
Patients who expressed wish to quit smoking but declines all support or use of SmokeFree app
Intervention Arm
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study participant will be recruited from the Acute Assessment Unit and Ambulatory Emergency Care at Chelsea and Westminster Hospital.
Chelsea and Westminster Hospital NHS Foundation Trust
London, Lonson, SW10 9NH, United Kingdom
First Submitted
February 9, 2021
First Posted
October 26, 2021
Study Start
December 4, 2019
Actual (reported)Primary Completion
December 4, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Level of engagement with the SmokeFree app
12 weeks
Contact the study team to confirm eligibility.
Study Completion
December 4, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 26, 2021
Record last verified: 2021-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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