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The SmokeFree App Smoking Cessation Study

NCT ID: NCT05094583

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-04

Study Completion Date

2021-12-04

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation Smoking Smoking Reduction Smoking Habit

Keywords

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Acute Assessment Unit Ambulatory Emergency Care

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention Arm

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

Use of SmokeFree app

Intervention Type BEHAVIORAL

Intervention Arm

Control Arm

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

No interventions assigned to this group

Interventions

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Use of SmokeFree app

Intervention Arm

Intervention Type BEHAVIORAL

Eligibility Criteria

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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:

Exclusion Criteria

* \< 18 years
* Patient refusal
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chelsea and Westminster Hospital NHS Foundation Trust

London, Lonson, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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C&W19/044

Identifier Type: -

Identifier Source: org_study_id