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

Jennifer Marler, MD

Status: Completed

Conditions: Smoking Cessation

Treatments: Device: Mobile smoking cessation program and CO breath sensor device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03295643

C-601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 319 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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319 participants in 1 patient group

Mobile smoking cessation program

Other group

Description:

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

Treatment:

Device: Mobile smoking cessation program and CO breath sensor device