RecruitmentTCapp-1NCT01626326
San Francisco Stop Smoking App - Pilot Study
An observational study of Recruitment, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is an initial pilot study to determine whether people will use a research version of an iPhone Stop Smoking app. The investigators primary measures will consist of rates of recruitment (that is, number of people installing the app), use of the app, and completion of follow-up surveys regarding self-reported… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recruitment
- What is being tested?
- San Francisco Stop Smoking iPhone app
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9,935 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults who use iPhone stop smoking apps
Who may be able to join
- 18 years of age or older
- Must download the iPhone app from iTunes at: https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8
Who cannot join
- less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psychiatry at San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Evaluation of a Stop Smoking iPhone App
This is an initial pilot study to determine whether people will use a research version of an iPhone Stop Smoking app. The investigators primary measures will consist of rates of recruitment (that is, number of people installing the app), use of the app, and completion of follow-up surveys regarding self-reported smoking status. The investigators secondary measure will be obtained quit rates and number of cigarettes smoked before and after using the app.
To enter the study, participants must download the app from iTunes at:
https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8
Read the detailed description
The investigators research team has developed smoking cessation self-help tools administered as printed brochures and Internet stop smoking sites. These self-help tools have demonstrated quit rates similar to those obtained with the nicotine patch. The investigators now want to see if mobile device apps might also help people quit.
This is the investigators first pilot study with a research version of the investigators stop smoking app for the iPhone. The investigators want to get estimates of how many people will download the app per month, how many will actually use the app, and how many will provide follow-up information on whether they quit, and if not, how many cigarettes they are smoking now. The investigators will use this information to plan a randomized controlled trial to determine efficacy of the app for stopping smoking.
- Conditions
- Recruitment
- Being tested
- San Francisco Stop Smoking iPhone app
- Keywords
- smoking, smoking cessation, mobile app
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
San Francisco Stop Smoking iPhone appBehavioural
iPhone app designed to help people quit smoking
| Study group | Role | What they receive |
|---|---|---|
| Stop smoking app | Stop smoking iPhone research app provided at no charge via the iTunes store Receives: Behavioral: San Francisco Stop Smoking iPhone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
Rates of recruitment into study (defined as number of users who provide consent by installing the app)
Measured: Three years
Secondary outcomes (3)
Utilization
Proportion of consented users who enter data into the app
Measured: One year
Follow-up completion rates
Proportion of consented users who provide smoking data at follow-ups
Measured: One year
Quit rates
Self-reported quit rates at 1, 3, and 6 months
Measured: 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionJun 2015
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 RecruitmentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,935 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo F Muñoz, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626326
- Sponsor's protocol ID
- TCapp-1
- Acronym
- TCapp-1
- Status last verified
- Nov 2018
- First submitted
- 20 Jun 2012
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Munoz RF, Marin BV, Posner SF, Perez-Stable EJ. Mood management mail intervention increases abstinence rates for Spanish-speaking Latino smokers. Am J Community Psychol. 1997 Jun;25(3):325-43. doi: 10.1023/a:1024676626955.
PubMed 9332966
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Stop Smoking iPhone App
- ClinicalTrials.gov ID
- NCT01626326
- Acronym / sponsor ID
- TCapp-1 / TCapp-1
- Conditions
- Recruitment
- Keywords
- smoking, smoking cessation, mobile app
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,935 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Jun 2012 (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.
This is an initial pilot study to determine whether people will use a research version of an iPhone Stop Smoking app. The investigators primary measures will consist of rates of recruitment (that is, number of people installing the app), use of the app, and completion of follow-up surveys regarding self-reported smoking status. The investigators secondary measure will be obtained quit rates and number of cigarettes smoked before and after using the app.
To enter the study, participants must download the app from iTunes at:
https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8
Detailed description
The investigators research team has developed smoking cessation self-help tools administered as printed brochures and Internet stop smoking sites. These self-help tools have demonstrated quit rates similar to those obtained with the nicotine patch. The investigators now want to see if mobile device apps might also help people quit.
This is the investigators first pilot study with a research version of the investigators stop smoking app for the iPhone. The investigators want to get estimates of how many people will download the app per month, how many will actually use the app, and how many will provide follow-up information on whether they quit, and if not, how many cigarettes they are smoking now. The investigators will use this information to plan a randomized controlled trial to determine efficacy of the app for stopping smoking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stop smoking app | – | Behavioral: San Francisco Stop Smoking iPhone appStop smoking iPhone research app provided at no charge via the iTunes store |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who use iPhone stop smoking apps
Key inclusion criteria (2 listed)
- 18 years of age or older
- Must download the iPhone app from iTunes at: https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8
Key exclusion criteria (1 listed)
- less than 18 years of age
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 |
|---|---|---|
| San Francisco Stop Smoking iPhone appiPhone app designed to help people quit smoking | Behavioural | Stop smoking app |
Primary outcome
Recruitment rates
Time frame: Three years
Rates of recruitment into study (defined as number of users who provide consent by installing the app)
3 secondary outcomes
Utilization
Time frame: One year
Follow-up completion rates
Time frame: One year
Quit rates
Time frame: 1, 3, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Background: PubMed 9332966Munoz RF, Marin BV, Posner SF, Perez-Stable EJ. Mood management mail intervention increases abstinence rates for Spanish-speaking Latino smokers. Am J Community Psychol. 1997 Jun;25(3):325-43. doi: 10.1023/a:1024676626955.
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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.
Ricardo F Muñoz, Ph.D. principal investigator
University of California, San Francisco
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 Recruitment, run by University of California, San Francisco at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 15 Nov 2018. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment rates (time frame: Three years). 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 NCT01626326, 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 15 Nov 2018.