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NCT03295643

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

Completed NA Results posted Last updated 1 July 2024
What this trial tests

NA trial testing Mobile smoking cessation program and CO breath sensor device in Smoking Cessation in 319 participants. Completed in 30 November 2018.

Timeline
4 October 2017
Primary endpoint
31 July 2018
30 November 2018

Quick facts

Lead sponsorJennifer Marler, MD
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment319
Start date4 October 2017
Primary completion31 July 2018
Estimated completion30 November 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Jennifer Marler, MD

Who can join

Adults 18 to 65, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Completed the Explore Stage Primary · 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.

GroupValue95% CI
Mobile Smoking Cessation Program283
Number of Participants Who Completed the Build Stage Primary · 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.

GroupValue95% CI
Mobile Smoking Cessation Program183
Number of Participants Who Completed the Mobilize Stage Primary · 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.

GroupValue95% CI
Mobile Smoking Cessation Program139
Number of Participants Who Completed the Quit Stage Primary · 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.

GroupValue95% CI
Mobile Smoking Cessation Program131
Number of Participants Who Completed the Secure Stage Primary · 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.

GroupValue95% CI
Mobile Smoking Cessation Program126
Readiness to Quit and Goals Related to Smoking Behavior Secondary · 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".

Baseline - Stage of Change
GroupValue95% CI
Mobile Smoking Cessation Program94
Mobile Smoking Cessation Program176
Mobile Smoking Cessation Program11
End of Explore Stage - Stage of Change
GroupValue95% CI
Mobile Smoking Cessation Program157
Mobile Smoking Cessation Program114
Mobile Smoking Cessation Program10
Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage Secondary · 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.

GroupValue95% CI
Mobile Smoking Cessation Program-44.5± 3
Weeks of Active Engagement Secondary · 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.

GroupValue95% CI
All Participants12.4± 7.1
Number of Participants Who Completed the Program Secondary · 6 months

The number of participants who completed the quit-smoking program.

GroupValue95% CI
Mobile Smoking Cessation Program272
Quit Attempts Secondary · 6 months

Number attempt to quit by participant

GroupValue95% CI
Mobile Smoking Cessation Program2.4± 3.1
Quit Rate 7-day Point Prevalence Secondary · 6 months

Number of participant who have not smoked in last 7 days

GroupValue95% CI
Mobile Smoking Cessation Program102
Quit Rate 30-day Point Prevalence Secondary · 6 months

Number of participant who have not smoked in last 30 days

GroupValue95% CI
Mobile Smoking Cessation Program88

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study.
    Marler JD, Fujii CA, Utley DS, Tesfamariam LJ, et al · · 2019 · cited 32× · PMID 30670372 · DOI 10.2196/12609
  2. Durability of Abstinence After Completing a Comprehensive Digital Smoking Cessation Program Incorporating a Mobile App, Breath Sensor, and Coaching: Cohort Study.
    Marler JD, Fujii CA, Galanko JA, Balbierz DJ, et al · · 2021 · cited 17× · PMID 33482628 · DOI 10.2196/25578

Verify or expand the search:

Other recruiting trials for Smoking Cessation

Currently open trials in the same condition.

Other Jennifer Marler, MD trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03295643.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing