Clinical trial NCT04955639: Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program
Official title: Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Pivot Health Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-09
Enrollment: 188
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: OTHER

Brief summary: Two-arm, parallel-group, non-crossover, single-center pilot randomized controlled trial, enrolling up to 180 participants to evaluate the effect of the Pivot smoking cessation program (intervention) compared to usual care (commercially available app smoking cessation program plus optional nicotine replacement therapy, control).

Detailed description: The present pilot randomized controlled trial compares user engagement and retention, change in attitudes towards quitting smoking, change in smoking behavior and participant feedback in adult smokers randomized either to the Pivot (intervention) or commercially available (control) smoking cessation programs.

We aim to assess participants' use of Pivot program and commercially available program. There will be a focus on assessing use and engagement, changes in attitudes towards quitting smoking and changes in smoking behavior over the course of the 2-year study, as well as participant feedback on the set-up, design, use experience, and impact of each program.

Eligibility criteria: Inclusion Criteria:

* 21+ years of age
* Current daily cigarette smokers (at least 5 cigarettes per day) for the past 12 months
* Plans to quit smoking in the next 30 days
* Resident of the United States
* Able to read and comprehend English
* Owns and uses a smart phone compatible with the study app (iPhone 5 and above with operating system (iOS) 12 and above, or, Android 7.0 and above with operating system Android 7.0 and above)
* Has daily internet access on smart phone
* Comfortable downloading and using smart phone apps
* Willing to sign the Informed Consent Form

Exclusion Criteria:

* Pregnancy (self-reported)
* Health contraindications to nicotine replacement therapy (NRT) use (irregular heartbeat, high blood pressure not controlled with medication, heart attack or stroke in last 2 months, pregnant or breast feeding, skin allergies to adhesive tape or serious skin problems, stomach ulcers, history of seizures)
* Using other smoking cessation support, including apps and/or actively taking medication to quit smoking
* Daily marijuana use
* Residence with another person who is a participant in this study
* Immediate family member is a participant in this study
* Failure to provide contact or collateral information, failure to verify email address, and/or failure to demonstrate videoconference capability
* Participation in a previous study sponsored by Carrot Inc.

Primary outcomes:
measure: Average Total App Openings at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Desire to Quit (Yes/no)
timeFrame: 4 weeks
measure: Change in Expected Difficulty in Staying Quit
timeFrame: 12 weeks
measure: Change in Confidence Levels Towards Quitting Smoking
timeFrame: 12 weeks
measure: Self-Reported Smoking Abstinence
timeFrame: 12 weeks
measure: Self-Reported Smoking Abstinence
timeFrame: 26 weeks
measure: Self-Reported Smoking Abstinence
timeFrame: 52 weeks
measure: Self-Reported Abstinence From All Tobacco Products
timeFrame: 12 weeks
measure: Self-Reported Abstinence From All Tobacco Products
timeFrame: 26 weeks
measure: Self-Reported Abstinence From All Tobacco Products
timeFrame: 52 weeks
measure: Biochemically Confirmed Abstinence
timeFrame: 12 weeks
measure: Biochemically Confirmed Abstinence
timeFrame: 26 weeks
measure: Biochemically Confirmed Abstinence
timeFrame: 52 weeks
measure: Self-Reported Continuous Abstinence
timeFrame: 26 weeks
measure: Self-Reported Continuous Abstinence
timeFrame: 52 weeks
measure: Biochemically Confirmed Continuous Abstinence
timeFrame: 26 weeks
measure: Biochemically Confirmed Continuous Abstinence
timeFrame: 52 weeks
measure: Proportion With ≥ 50% CPD Reduction
timeFrame: 26 weeks
measure: User Satisfaction - User Feedback
timeFrame: 2 weeks
measure: Additional User Feedback
timeFrame: 3 weeks
measure: User Feedback - Setup and Starting the Program
timeFrame: 12 weeks
measure: User Feedback
timeFrame: 26 weeks
measure: User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking
timeFrame: 52 weeks
measure: User Satisfaction - Net Promoter Score (NPS)
timeFrame: 4 weeks, 12 weeks, and 26 weeks
measure: Engagement With Program - Number of Times App Was Opened
timeFrame: 12 weeks
measure: Engagement With Program - Number of Days App Was Opened
timeFrame: 12 weeks
measure: Engagement With Program - Number of Weeks App Was Opened
timeFrame: 12 weeks
measure: Participant Changes in Self-Efficacy
timeFrame: 12 weeks
measure: Participant Changes in Self-Efficacy
timeFrame: 52 weeks
measure: Participant Changes in Self-reported Health and Wellbeing
timeFrame: 12 weeks
measure: Self-Reported Nicotine Replacement Therapy (NRT) Use
timeFrame: 26 weeks
measure: Self-Reported Nicotine Replacement Therapy (NRT) Use
timeFrame: 52 weeks
measure: Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Carlos
country: United States
facility: Pivot Health Technologies, Inc.
state: California
Study officials:
affiliation: Pivot Health Technologies Inc.
name: Jennifer Marler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marler JD, Fujii CA, Utley MT, Balbierz DJ, Galanko JA, Utley DS. Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Nov 24;10(11):e41658. doi: 10.2196/41658.