Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months

Not Applicable

Completed

Conditions: Smoking Cessation

Interventions: Device: Mobile smoking cessation program and CO breath sensor device

Registration Number: NCT03295643

Lead Sponsor: Jennifer Marler, MD

Brief Summary: Prospective, open label, single center clinical study enrolling 260 subjects in a mobile smoking cessation program using a smartphone app and a handheld breath sensor with coaching support over a six month period.

Detailed Description: This is a prospective, open label, single center clinical study enrolling 260 subjects in a mobile smoking cessation program using a smartphone app and handheld breath sensor with coaching support over a six month period. Measurements include user engagement and retention in the program, attitude towards smoking and smoking behavior, quit rates, relapse rates, and quality of life over the study period, as well as user feedback on the program.

Potential participants will complete an online screening form. Eligible participants will be called to confirm eligibility, discuss the study, and have their questions about the study answered. Interested eligible participants will then be emailed the registration link, which includes the electronic informed consent. After providing electronic informed consent, subjects register online and receive the hand held device which measures carbon monoxide (CO) which correlates to smoking behavior.

Baseline questionnaires (demographics, smoking history, and attitude towards smoking) are completed, and subjects then self-train to use the breath sensor and smartphone app and allows viewing of CO sample values. The app also provides the user with ability to log cigarettes, view cigarette consumption trends, view instructional videos, complete educational activities and challenges, and engage with a coach.

Participants will experience the program in 5 phases and then complete the study at approximately six months after enrolling,activating device and app.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 319

Inclusion Criteria

18-65 years of age
English speaking
Smokes daily
Smokes 5 or more cigarettes per day
Owns and uses a smartphone (iPhone 5 and above, operating system iOS 9.0 and above, or, Android 4.4 and above, operating system Android 4.4 and above)
Employed at least 20 hours per week
Lives in the USA
Understands and willing to sign the Informed Consent Form

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mobile smoking cessation program	Mobile smoking cessation program and CO breath sensor device	Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Completed the Secure Stage	Assessment at the end of the Secure Stage; between 101 and 128 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days. Secure = 11 weeks.	For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage.
Number of Participants Who Completed the Mobilize Stage	Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.	For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.
Number of Participants Who Completed the Build Stage	Assessment at the end of the Build stage; between 10 and 37 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.	For the number of participants who started the Build Stage, the proportion who completed the Build Stage.
Number of Participants Who Completed the Explore Stage	Assessment at the end of the Explore stage; 9 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.	For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage.
Number of Participants Who Completed the Quit Stage	Assessment at the end of the Quit Stage; between 24 and 51 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days.	For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking	6 months	the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking
Quit Rate 30-day Point Prevalence	6 months	Number of participant who have not smoked in last 30 days
Readiness to Quit and Goals Related to Smoking Behavior	Assessment at the end of the Explore stage; 9 days after activating app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.	Are you seriously thinking of quitting smoking? (stage of change) "Yes, within the next 30 days". "Yes, within the next 6 months". "No, not thinking of quitting".
Weeks of Active Engagement	6 months	Engagement defined as interaction with the program at least once within app (app open, daily check-in, responds to coach, logs cigarettes, etc) Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Number of Participants Who Completed the Program	6 months	The number of participants who completed the quit-smoking program.
Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage	Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.	Average percentage change in cigarettes per day (CPD) by the Pre-Quit Stage using repeated measures linear mixed model analysis. Model uses all available data on CPD to estimate an average. The Pre-Quit Stage is defined as from the start of the study (activation of the app and device/ Baseline) to the end of the Mobilize Stage.
Quit Rate 7-day Point Prevalence	6 months	Number of participant who have not smoked in last 7 days
Quit Attempts	6 months	Number attempt to quit by participant
Difficulty Maintaining Quit	Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.	Difficulty maintaining quit. Estimate of means and standard errors based on linear mixed model. Participants were asked: "If you were to quit smoking right now, how difficult do you think it would be to stay smoke-free?" Answered on a scale from 1 to 10 (1=really hard to stay quit, 10=really easy to stay quit).
Confidence to Quit	Assessment at the end of the Mobilize Stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.	Confidence to quit. Estimate of means and standard errors based on linear mixed model. Participants were asked: "If you were to quit smoking right now, how successful would you be?" Answered on a scale from 1 to 10 (1=not at all successful, 10=completely successful).