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

NCT ID: NCT03295643

Last Updated: 2024-07-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-04

Study Completion Date

2018-11-30

Brief Summary

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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

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects experience same program
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mobile smoking cessation program

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

Group Type OTHER

Mobile smoking cessation program and CO breath sensor device

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jennifer Marler, MD

INDUSTRY

Sponsor Role lead

Responsible Party

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Jennifer Marler, MD

Senior Director, Clinical and Medical Affairs

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Utley, MD

Role: PRINCIPAL_INVESTIGATOR

Pivot Health Technologies, Inc (formerly Carrot Sense)

Locations

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Carrot Inc.

Redwood City, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33482628 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30670372 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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C-601

Identifier Type: -

Identifier Source: org_study_id

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