Smoking Cessation
Conditions
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.
Interventions
DEVICEMobile 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.
Sponsors
Jennifer Marler, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All subjects experience same program
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quit Rate 7-day Point Prevalence | 6 months | Number of participant who have not smoked in last 7 days |
| 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. |
| 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). |
| 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). |
| 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 |
| 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. |
| 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. |
| Quit Attempts | 6 months | Number attempt to quit by participant |
Countries
United States
Participant flow
Recruitment details
Online recruitment
Pre-assignment details
Phone call to confirm eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Mobile Smoking Cessation Program 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. | 319 |
| Total | 319 |
Baseline characteristics
| Characteristic | Mobile Smoking Cessation Program |
|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 10.2 |
| Cigarettes smoked per day | 17.7 Cigarettes per day STANDARD_DEVIATION 7.6 |
| Race/Ethnicity, Customized Ethnicity African American | 22 Participants |
| Race/Ethnicity, Customized Ethnicity American Indian or Alaska Native | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 15 Participants |
| Race/Ethnicity, Customized Ethnicity Native Hawaiian or other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 7 Participants |
| Race/Ethnicity, Customized Ethnicity White | 264 Participants |
| Region of Enrollment United States | 319 participants |
| Sex: Female, Male Female | 184 Participants |
| Sex: Female, Male Male | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 319 |
| other Total, other adverse events | 0 / 319 |
| serious Total, serious adverse events | 0 / 319 |
Outcome results
Primary
Number of Participants Who Completed the Build Stage
For the number of participants who started the Build Stage, the proportion who completed the Build Stage.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Smoking Cessation Program | Number of Participants Who Completed the Build Stage | 183 Participants |
Primary
Number of Participants Who Completed the Explore Stage
For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Smoking Cessation Program | Number of Participants Who Completed the Explore Stage | 283 Participants |
Primary
Number of Participants Who Completed the Mobilize Stage
For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Smoking Cessation Program | Number of Participants Who Completed the Mobilize Stage | 139 Participants |
Primary
Number of Participants Who Completed the Quit Stage
For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Smoking Cessation Program | Number of Participants Who Completed the Quit Stage | 131 Participants |
Primary
Number of Participants Who Completed the Secure Stage
For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Smoking Cessation Program | Number of Participants Who Completed the Secure Stage | 126 Participants |
Secondary
Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Smoking Cessation Program | Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage | -44.5 percentage change in cpd | Standard Deviation 3 |
Secondary
Confidence to Quit
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile Smoking Cessation Program | Confidence to Quit | Baseline Confidence to Quit | 4.2 score on a scale | Standard Error 0.1443 |
| Mobile Smoking Cessation Program | Confidence to Quit | End of Explore Confidence to Quit | 5.9 score on a scale | Standard Error 0.1508 |
| Mobile Smoking Cessation Program | Confidence to Quit | End of Build Confidence to Quit | 6.4 score on a scale | Standard Error 0.1782 |
| Mobile Smoking Cessation Program | Confidence to Quit | End of Mobilize Confidence to Quit | 7.4 score on a scale | Standard Error 0.1916 |
Secondary
Difficulty Maintaining Quit
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile Smoking Cessation Program | Difficulty Maintaining Quit | Baseline difficulty maintaining quit | 3.1 score on a scale | Standard Error 0.1449 |
| Mobile Smoking Cessation Program | Difficulty Maintaining Quit | End of Explore difficulty maintaining quit | 4.9 score on a scale | Standard Error 0.1531 |
| Mobile Smoking Cessation Program | Difficulty Maintaining Quit | End of Build difficulty maintaining quit | 5.7 score on a scale | Standard Error 0.1891 |
| Mobile Smoking Cessation Program | Difficulty Maintaining Quit | End of Mobilize difficulty maintaining quit | 6.8 score on a scale | Standard Error 0.2055 |
Secondary
Number of Participants Who Completed the Program
The number of participants who completed the quit-smoking program.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Smoking Cessation Program | Number of Participants Who Completed the Program | 272 Participants |
Secondary
Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking
the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Smoking Cessation Program | Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking | 233 Participants |
Secondary
Quit Attempts
Number attempt to quit by participant
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Smoking Cessation Program | Quit Attempts | 2.4 quit attempts | Standard Deviation 3.1 |
Secondary
Quit Rate 30-day Point Prevalence
Number of participant who have not smoked in last 30 days
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Smoking Cessation Program | Quit Rate 30-day Point Prevalence | 88 Participants |
Secondary
Quit Rate 7-day Point Prevalence
Number of participant who have not smoked in last 7 days
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Smoking Cessation Program | Quit Rate 7-day Point Prevalence | 102 Participants |
Secondary
Readiness to Quit and Goals Related to Smoking Behavior
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.
Time frame: 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.
Population: Participants who provided baseline and explore stage results
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Mobile Smoking Cessation Program | Readiness to Quit and Goals Related to Smoking Behavior | Baseline - Stage of Change | Yes, within the next 30 days | 94 Participants |
| Mobile Smoking Cessation Program | Readiness to Quit and Goals Related to Smoking Behavior | Baseline - Stage of Change | Yes, within the next 6 months | 176 Participants |
| Mobile Smoking Cessation Program | Readiness to Quit and Goals Related to Smoking Behavior | Baseline - Stage of Change | No, not thinking of quitting | 11 Participants |
| Mobile Smoking Cessation Program | Readiness to Quit and Goals Related to Smoking Behavior | End of Explore Stage - Stage of Change | Yes, within the next 30 days | 157 Participants |
| Mobile Smoking Cessation Program | Readiness to Quit and Goals Related to Smoking Behavior | End of Explore Stage - Stage of Change | Yes, within the next 6 months | 114 Participants |
| Mobile Smoking Cessation Program | Readiness to Quit and Goals Related to Smoking Behavior | End of Explore Stage - Stage of Change | No, not thinking of quitting | 10 Participants |
Secondary
Weeks of Active Engagement
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Smoking Cessation Program | Weeks of Active Engagement | 12.4 weeks | Standard Deviation 7.1 |