Clinical trial NCT03295643: Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months
Official title: Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Pivot Health Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-28
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects experience same program
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Completed the Explore Stage
timeFrame: 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.
measure: Number of Participants Who Completed the Build Stage
timeFrame: 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.
measure: Number of Participants Who Completed the Mobilize Stage
timeFrame: 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.
measure: Number of Participants Who Completed the Quit Stage
timeFrame: 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.
measure: Number of Participants Who Completed the Secure Stage
timeFrame: 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 outcomes:
measure: Readiness to Quit and Goals Related to Smoking Behavior
timeFrame: 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.
measure: Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage
timeFrame: 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.
measure: Weeks of Active Engagement
timeFrame: 6 months
measure: Number of Participants Who Completed the Program
timeFrame: 6 months
measure: Quit Attempts
timeFrame: 6 months
measure: Quit Rate 7-day Point Prevalence
timeFrame: 6 months
measure: Quit Rate 30-day Point Prevalence
timeFrame: 6 months
measure: Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking
timeFrame: 6 months
measure: Confidence to Quit
timeFrame: 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.
measure: Difficulty Maintaining Quit
timeFrame: 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.
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Carrot Inc.
state: California
Study officials:
affiliation: Pivot Health Technologies, Inc (formerly Carrot Sense)
name: David Utley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marler JD, Fujii CA, Galanko JA, Balbierz DJ, Utley DS. Durability of Abstinence After Completing a Comprehensive Digital Smoking Cessation Program Incorporating a Mobile App, Breath Sensor, and Coaching: Cohort Study. J Med Internet Res. 2021 Feb 15;23(2):e25578. doi: 10.2196/25578.
citation: Marler JD, Fujii CA, Utley DS, Tesfamariam LJ, Galanko JA, Patrick H. Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study. JMIR Mhealth Uhealth. 2019 Feb 4;7(2):e12609. doi: 10.2196/12609.