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

NCT03295643 | Completed Results FDA Device

• 1 other identifier: C-601
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (10)

• 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.

• 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.

• Weeks of Active Engagement

  6 months

• Number of Participants Who Completed the Program

  6 months

• Quit Attempts

  6 months

Study Arms (1)

Mobile smoking cessation program

OTHER

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

Device: Mobile smoking cessation program and CO breath sensor device

Interventions

Mobile smoking cessation program and CO breath sensor device DEVICE

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

Mobile smoking cessation program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Jennifer Marler, MD: lead

Study Sites (1)

Carrot Inc.

Redwood City, California, 94063, United States

Location

Related Publications (2)

• 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.

  PMID: 33482628 DERIVED

• 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.

  PMID: 30670372 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Senior Director of Clinical Affairs and Data Science
• Organization: Pivot Health Technologies Inc.

craig@pivot.co

650-906-4255

Study Officials

• David Utley, MD

  Pivot Health Technologies, Inc (formerly Carrot Sense)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Director, Clinical and Medical Affairs

Model Details: All subjects experience same program

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: October 4, 2017
• Primary Completion: July 31, 2018
• Study Completion: November 30, 2018
• Last Updated: July 1, 2024
• Results First Posted: November 10, 2022

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)