Smoking CessationSMOKEFREENCT05094583
The SmokeFree App Smoking Cessation Study
An observational study of Smoking Cessation and Smoking, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Smoking, Smoking Reduction
- What is being tested?
- Use of SmokeFree app
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Dec 2019to 4 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study participant will be recruited from the Acute Assessment Unit and Ambulatory Emergency Care at Chelsea and Westminster Hospital.
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- < 18 years
- Patient refusal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital NHS Foundation Trust
London, Lonson, SW10 9NH
About this study
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.
Read more
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
- Being tested
- Use of SmokeFree app
- Keywords
- Acute Assessment Unit, Ambulatory Emergency Care
- Medical subject headings
- Smoking Cessation, Smoking, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of SmokeFree appBehavioural
Intervention Arm
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Patients who expressed wish to quit smoking and accept use of the SmokeFree app Receives: Behavioral: Use of SmokeFree app | |
| Control Arm | Patients who expressed wish to quit smoking but declines all support or use of SmokeFree app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start4 Dec 2019
- Primary completion4 Dec 2021 (estimated)
- Study completion4 Dec 2021 (estimated)
Why it stopped: Suspended due to COVID19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094583
- Sponsor's protocol ID
- C&W19/044
- Acronym
- SMOKEFREE
- Status last verified
- Oct 2021
- First submitted
- 9 Feb 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SmokeFree App Smoking Cessation Study
- ClinicalTrials.gov ID
- NCT05094583
- Acronym / sponsor ID
- SMOKEFREE / C&W19/044
- Conditions
- Smoking Cessation, Smoking, Smoking Reduction, Smoking Habit
- Keywords
- Acute Assessment Unit, Ambulatory Emergency Care
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Suspended due to COVID19 pandemic.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 4 Dec 2021 (estimated)
- Study completion
- 4 Dec 2021 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | – | Behavioral: Use of SmokeFree appPatients who expressed wish to quit smoking and accept use of the SmokeFree app |
| Control Arm | – | –Patients who expressed wish to quit smoking but declines all support or use of SmokeFree app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study participant will be recruited from the Acute Assessment Unit and Ambulatory Emergency Care at Chelsea and Westminster Hospital.
Key inclusion criteria (10 listed)
- ≥ 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)
Key exclusion criteria (2 listed)
- < 18 years
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of SmokeFree appIntervention Arm | Behavioural | Intervention Arm |
Primary outcome
Smoking abstinence
Time frame: 12 weeks
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Smoking, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking abstinence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.