Smoking Cessation Clinical Trial
Official title:
Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months
NCT number | NCT03295643 |
Other study ID # | C-601 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 4, 2017 |
Est. completion date | November 30, 2018 |
Verified date | October 2022 |
Source | Pivot Health Technologies Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 319 |
Est. completion date | November 30, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Carrot Inc. | Redwood City | California |
Lead Sponsor | Collaborator |
---|---|
Jennifer Marler, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 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. | |
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. | 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. | |
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. | 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. | |
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. | 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. | |
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. | 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. | |
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". | 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. | |
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. |
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. | |
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. |
6 months | |
Secondary | Number of Participants Who Completed the Program | The number of participants who completed the quit-smoking program. | 6 months | |
Secondary | Quit Attempts | Number attempt to quit by participant | 6 months | |
Secondary | Quit Rate 7-day Point Prevalence | Number of participant who have not smoked in last 7 days | 6 months | |
Secondary | Quit Rate 30-day Point Prevalence | Number of participant who have not smoked in last 30 days | 6 months | |
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 | 6 months | |
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). |
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. | |
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). |
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. |
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