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Trial record 8 of 2035 for:    Smoking Cessation

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

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ClinicalTrials.gov Identifier: NCT03295643
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Carrot Sense

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Device: Mobile smoking cessation program and CO breath sensor device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects experience same program
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months
Actual Study Start Date : October 4, 2017
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Phase 1 completion [ Time Frame: 9 days after activating app and device ]
    For the number of participants who started a phase 1, the proportion who completed that phase, assessed for each phase of the Pivot program

  2. Phase 2 completion [ Time Frame: 28 days post phase 1 ]
    For the number of participants who started a phase 2, the proportion who completed that phase, assessed for each phase of the Pivot program

  3. Phase 3 completion [ Time Frame: 7 days post phase 2 ]
    For the number of participants who started a phase 3, the proportion who completed that phase, assessed for each phase of the Pivot program

  4. Phase 4 completion [ Time Frame: 7 days post phase 3 ]
    For the number of participants who started a phase 4, the proportion who completed that phase, assessed for each phase of the Pivot program

  5. Phase 5 completion [ Time Frame: 11 weeks post phase 4 ]
    For the number of participants who started a phase 5, the proportion who completed that phase, assessed for each phase of the Pivot program


Secondary Outcome Measures :
  1. Weeks of active engagement [ Time Frame: 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)

  2. Program completion [ Time Frame: 6 months ]
    Completion of program

  3. Number of cigarettes smoked per day [ Time Frame: 6 months ]
    Number of cigarettes smoked per day by participant

  4. Quit attempts [ Time Frame: 6 months ]
    Number attempt to quit by participant

  5. Quit rate 7-day point prevalence [ Time Frame: 6 months ]
    Number of participant who have not smoked in last 7 days

  6. Quit rate 30-day point prevalence [ Time Frame: 6 months ]
    Number of participant who have not smoked in last 30 days

  7. Responses to questionnaires [ Time Frame: 6 months ]
    Readiness to quit, Goals related to smoking behavior, Confidence to quit, Difficulty maintaining quit

  8. Net Promoter Score (NPS) [ Time Frame: 6 month ]
    Net Promoter Score assessment for app, coaching



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295643


Locations
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United States, California
Carrot Inc.
Redwood City, California, United States, 94063
Sponsors and Collaborators
Carrot Sense
Investigators
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Principal Investigator: David Utley Carrot Sense

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carrot Sense
ClinicalTrials.gov Identifier: NCT03295643     History of Changes
Other Study ID Numbers: C-601
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No