SmokingPhase 1NCT02932917
MapMySmoke: Smoking Cessation App With Geospatial Capture
A Phase 1 study testing MapMySmoke in people with Smoking and Cigarette Smoking, run by University of St Andrews.
Trial summary
Place-based cues can be an important trigger of smoking behavior, therefore the investigators wish to learn more about the influence of the built environment on individual smoking behavior. This is to facilitate dynamic support during the post-quit phase. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette Smoking, Smoking, Tobacco
- What is being tested?
- MapMySmoke
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2017
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- National Health Service (Fife) Patients
- Self-reported tobacco smoker
- Stated intention to quit smoking
- English speaker
Who cannot join
- Mental illness
- learning difficulty
About this study
Official title: MapMySmoke: Feasibility of a New Quit Cigarette Smoking Mobile Phone Application Using Integrated Geo-positioning Technology, and Motivational Messaging Within Primary Care Setting
Place-based cues can be an important trigger of smoking behavior, therefore the investigators wish to learn more about the influence of the built environment on individual smoking behavior. This is to facilitate dynamic support during the post-quit phase. MapMySmoke is a mobile phone application that enables the capture of spatial data during smoking and craving events. These data will be used to create individualized support plans via the app.
Read the detailed description
Investigators know that place-based cues play an important role in the triggering of smoking events, and even in relapse events. It follows that providing individual smokers with spatially explicit and temporally dynamic intervention messages may support smoking cessation attempts.
The investigators have built a mobile phone application-MayMySmoke-that allows individuals to capture each smoking event at the times and places they occur, and tag the events with qualitative metadata. The app also allows individuals to document and describe craving events. The goal of the app is first to understand an individual's smoking profile, and second to support them with dynamic text messages.
The investigators are deploying the app in a clinical setting-the United Kingdom's National Health Service, within the Fife region of Scotland. Using two feasibility studies of increasing size, the investigators are attempting first to get initial feedback on the app, and then to improve the app and deploy it across a broader community of smokers.
Though the app is targeted to smoking behavior, it is possible to extend it to include other negative health behaviors that may have a spatial component.
- Conditions
- Smoking, Cigarette Smoking, Smoking, Tobacco
- Being tested
- MapMySmoke
- Medical subject headings
- Smoking, Cigarette Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MapMySmokeDevice
Each patient in the study arm will download and install the MapMySmoke app to record all of their smoking and craving events. The app will generate a quantitative summary of their smoking behavior during a pre-quit phase, and will provide dynamic text support messages during the post-quit phase. The app will also capture spatial details of any relapse events during the post-quit phase.
| Study group | Role | What they receive |
|---|---|---|
| MapMySmoke | Experimental | All patients in the study will use the MapMySmoke app to document their smoking and craving behavior Receives: Device: MapMySmoke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continued use of the MapMySmoke App as Assessed by Monitoring Individual Anonymized Data Feeds on the Server
The investigators will determine, via the data feed to the server, if patients continue to use the app during the pre- and post-quit phase
Measured: 1 year
Secondary outcomes (2)
Number of Patients Using the App Who Are Abstinent from Smoking As Assessed by Follow-up Survey
The investigators will determine via survey if patients have maintained their quit attempt
Measured: 4 weeks
Number of Patients Using the App Who Are Abstinent from Smoking As Assessed by Follow-up Survey
The investigators will determine via survey if patients have maintained their quit attempt
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of St Andrews
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Principal investigator, Robert Schick, University of St Andrews
- Investigators
- Robert S Schick, PhD, Principal investigator, University of St Andrews
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932917
- Sponsor's protocol ID
- XAP062
- Status last verified
- May 2017
- First submitted
- 12 Oct 2016
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Schick RS, Kelsey TW, Marston J, Samson K, Humphris GW. MapMySmoke: feasibility of a new quit cigarette smoking mobile phone application using integrated geo-positioning technology, and motivational messaging within a primary care setting. Pilot Feasibility Stud. 2017 Jul 14;4:19. doi: 10.1186/s40814-017-0165-4. eCollection 2018.
PubMed 28725452
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MapMySmoke: Feasibility of a New Quit Cigarette Smoking Mobile Phone Application Using Integrated Geo-positioning Technology, and Motivational Messaging Within Primary Care Setting
- ClinicalTrials.gov ID
- NCT02932917
- Acronym / sponsor ID
- XAP062
- Conditions
- Smoking, Cigarette Smoking, Smoking, Tobacco
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of St AndrewsUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- 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.
Place-based cues can be an important trigger of smoking behavior, therefore the investigators wish to learn more about the influence of the built environment on individual smoking behavior. This is to facilitate dynamic support during the post-quit phase. MapMySmoke is a mobile phone application that enables the capture of spatial data during smoking and craving events. These data will be used to create individualized support plans via the app.
Detailed description
Investigators know that place-based cues play an important role in the triggering of smoking events, and even in relapse events. It follows that providing individual smokers with spatially explicit and temporally dynamic intervention messages may support smoking cessation attempts.
The investigators have built a mobile phone application-MayMySmoke-that allows individuals to capture each smoking event at the times and places they occur, and tag the events with qualitative metadata. The app also allows individuals to document and describe craving events. The goal of the app is first to understand an individual's smoking profile, and second to support them with dynamic text messages.
The investigators are deploying the app in a clinical setting-the United Kingdom's National Health Service, within the Fife region of Scotland. Using two feasibility studies of increasing size, the investigators are attempting first to get initial feedback on the app, and then to improve the app and deploy it across a broader community of smokers.
Though the app is targeted to smoking behavior, it is possible to extend it to include other negative health behaviors that may have a spatial component.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MapMySmoke | Experimental | Device: MapMySmokeAll patients in the study will use the MapMySmoke app to document their smoking and craving behavior |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- National Health Service (Fife) Patients
- Self-reported tobacco smoker
- Stated intention to quit smoking
- English speaker
Key exclusion criteria (2 listed)
- Mental illness
- learning difficulty
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 |
|---|---|---|
| MapMySmokeEach patient in the study arm will download and install the MapMySmoke app to record all of their smoking and craving events. The app will generate a quantitative summary of their smoking behavior during a pre-quit phase, and will provide dynamic text support messages during the post-quit phase. The app will also capture spatial details of any relapse events during the post-quit phase. | Device | MapMySmoke |
Primary outcome
Continued use of the MapMySmoke App as Assessed by Monitoring Individual Anonymized Data Feeds on the Server
Time frame: 1 year
The investigators will determine, via the data feed to the server, if patients continue to use the app during the pre- and post-quit phase
2 secondary outcomes
Number of Patients Using the App Who Are Abstinent from Smoking As Assessed by Follow-up Survey
Time frame: 4 weeks
Number of Patients Using the App Who Are Abstinent from Smoking As Assessed by Follow-up Survey
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Derived from this study: PubMed 28725452Schick RS, Kelsey TW, Marston J, Samson K, Humphris GW. MapMySmoke: feasibility of a new quit cigarette smoking mobile phone application using integrated geo-positioning technology, and motivational messaging within a primary care setting. Pilot Feasibility Stud. 2017 Jul 14;4:19. doi: 10.1186/s40814-017-0165-4. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Robert S Schick, PhD principal investigator
University of St Andrews
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MapMySmoke in people with Smoking and Cigarette Smoking, run by University of St Andrews.
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 4 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: status not confirmed, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Continued use of the MapMySmoke App as Assessed by Monitoring Individual Anonymized Data Feeds on the Server (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02932917, which also lists 1 linked publication.
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 22 May 2017.