San Francisco Stop Smoking App - Pilot Study | NCT01626326

Studies
San Francisco Stop Smoking App - Pilot Study

NCT01626326

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Nov 15, 2018Actual

Enrollment

9,935Actual

Phase

Not provided

Conditions

Recruitment

Interventions

San Francisco Stop Smoking iPhone app

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jun 20, 2012

First Submission Date that Met QC Criteria

Jun 21, 2012

First Posted Date

Jun 22, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2018

Last Update Posted Date

Nov 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,935Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stop smoking app		Stop smoking iPhone research app provided at no charge via the iTunes store	Behavioral: San Francisco Stop Smoking iPhone app

Interventions

Name	Type	Description	Arm Group Labels	Other Names
San Francisco Stop Smoking iPhone app	Behavioral	iPhone app designed to help people quit smoking	Stop smoking app

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recruitment rates	Rates of recruitment into study (defined as number of users who provide consent by installing the app)	Three years

Secondary Outcomes

Measure	Description	Time Frame
Utilization	Proportion of consented users who enter data into the app	One year
Follow-up completion rates	Proportion of consented users who provide smoking data at follow-ups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

less than 18 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults who use iPhone stop smoking apps

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ricardo F Muñoz, Ph.D.	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Psychiatry at San Francisco General Hospital		San Francisco	California	94110	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9332966	Background	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.

ID	Term
D012907	Smoking
D016540	Smoking Cessation

ID	Term
D001519	Behavior
D015438	Health Behavior