Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program

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).

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Control; Other: Pivot

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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Carlos, California, United States, 94070
      • Pivot Health Technologies, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; A commercially available mobile phone app and program	Other: Control; Standard of Care - Control Smoking Cessation Program; Other Names: Standard of Care
Active Comparator: Pivot; Pivot mobile phone app and program	Other: Pivot; Pivot Program Smoking Cessation Program; Other Names: Pivot Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Total App Openings at 12 Weeks	App/program engagement is assessed with the self-report of total app openings through the first 12 weeks of the program. Calculated by summing the number of weekly app openings reported by participants weekly.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desire to Quit (Yes/no)	desire to quit smoking, participant self-report, yes/no	4 weeks
Change in Expected Difficulty in Staying Quit	Expected difficulty to stay quit from smoking. Participants asked: "How difficult do you think it would be to stay smoke free?". Participant self-report on scale 1-10 (1=Really hard to stay quit, 10=Really easy to stay quit)	12 weeks
Change in Confidence Levels Towards Quitting Smoking	Expected success in quitting smoking. Asked: " If you were to quit smoking right now, how successful would you be?". Participant self-report, scale 1-10 (1=Not at all successful, 10=Completely successful).	12 weeks
Self-Reported Smoking Abstinence	participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes	12 weeks
Self-Reported Smoking Abstinence	participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes	26 weeks
Self-Reported Smoking Abstinence	participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes	52 weeks
Self-Reported Abstinence From All Tobacco Products	participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah	12 weeks
Self-Reported Abstinence From All Tobacco Products	Participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah.	26 weeks
Self-Reported Abstinence From All Tobacco Products	Participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah.	52 weeks
Biochemically Confirmed Abstinence	Participants who report they have achieved at least 7-day point prevalence abstinence at 12 weeks will undergo a videoconference visit with study staff in which they provide a witnessed breath sample using a provided personal mobile carbon monoxide breath sensor. Breath sample values less than 10 ppm (parts per million) will be considered consistent with biochemical abstinence.	12 weeks
Biochemically Confirmed Abstinence	Participants who report they have achieved at least 7-day point prevalence abstinence at 26 weeks will undergo a videoconference visit with study staff in which they provide a witnessed breath sample using a provided personal mobile carbon monoxide breath sensor. Breath sample values less than 10 ppm (parts per million) will be considered consistent with biochemical abstinence.	26 weeks
Biochemically Confirmed Abstinence	Participants who report they have achieved at least 7-day point prevalence abstinence at 52 weeks will undergo a videoconference visit with study staff in which they provide a witnessed breath sample using a provided personal mobile carbon monoxide breath sensor. Breath sample values less than 10 ppm (parts per million) will be considered consistent with biochemical abstinence.	52 weeks
Self-Reported Continuous Abstinence	Defined as self-report of 7-day PPA or greater at 12 weeks, 30-day PPA at 26 weeks, and no more than 5 cigarettes during the intervening time period.	26 weeks
Self-Reported Continuous Abstinence	Defined as self-report of 7-day PPA or greater at 12 weeks, 30-day PPA at 26 weeks, and no more than 5 cigarettes during the intervening time period.	52 weeks
Biochemically Confirmed Continuous Abstinence	Defined as self-report of smoking no more than five cigarettes from 12 weeks after enrollment, and biochemical confirmation of abstinence on all previous and present biovalidation tests, with biochemical confirmation defined as: Participants who report they have achieved at least 7-day point prevalence abstinence at 12 weeks and 26 weeks will undergo a videoconference visit with study staff in which they provide a witnessed breath sample using a provided personal mobile carbon monoxide breath sensor. Breath sample values less than 10 ppm (parts per million) will be considered consistent with biochemical abstinence.	26 weeks
Biochemically Confirmed Continuous Abstinence	Defined as self-report of smoking no more than five cigarettes from 12 weeks after enrollment, and biochemical confirmation of abstinence on all previous and present biovalidation tests, with biochemical confirmation defined as: Participants who report they have achieved at least 7-day point prevalence abstinence at 12 weeks, 26 weeks, and 52 weeks will undergo a videoconference visit with study staff in which they provide a witnessed breath sample using a provided personal mobile carbon monoxide breath sensor. Breath sample values less than 10 ppm (parts per million) will be considered consistent with biochemical abstinence.	52 weeks
Proportion With ≥ 50% CPD Reduction	The proportion of participants who reduced their cigarettes per day (CPD) by ≥ 50% compared to baseline	26 weeks
User Satisfaction - User Feedback	User satisfaction with the smoking cessation program, specifically its impact on motivation to quit smoking, and the amount of cigarettes smoked per day. Participants were asked: "How has using your assigned program affected your motivation to quit smoking?" and "How has using your assigned program affected the number of cigarettes you smoke per day?" with the answer choices of "increased", "not affected", and "decreased".	2 weeks
Additional User Feedback	User feedback on what they have learned from using their assigned smoking cessation program. Participants were asked "Which of the following best described what you have learned from using your program?" with the answer choices: "I've learned some really unique/key insights into my smoking behavior", "I've learned some things but nothing that impactful", "I have not learned anything from the program", and "I am more confused after using the program".	3 weeks
User Feedback - Setup and Starting the Program	User feedback with the smoking cessation program, specifically ease of set-up and starting of the program (scale of 1-10, higher value equates to easier time setting up and starting use of the program)	12 weeks
User Feedback	User feedback with the smoking cessation program, specifically whether the program helped with their smoking cessation goals (true/false), and whether the program helped them quit smoking (true/false).	26 weeks
User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking	User feedback with the smoking cessation program, specifically whether the program helped them quit smoking (true/false).	52 weeks
User Satisfaction - Net Promoter Score (NPS)	User satisfaction with the smoking cessation program, specifically the likelihood of recommending the program to a friend. Measured with a net promoter score (NPS). Participants are asked "How likely are you to recommend your study program to a friend or colleague?" and answer on a 10-point (1-10) scale (where 1=Not at all likely and 10=Very likely). NPS was calculated for each study group by subtracting the percentage of respondents who answered ≤6 (detractors) from the percentage of respondents who answered 9 or 10 (promotors). NPS formula = %promotor - %detractor NPS has a score range between -100 and 100 (-100 indicates 100% detractors, 100 indicated 100% promotors of the program). A higher NPS score indicates greater promoters of the program, and thus a greater likelihood of individuals recommending the program to a friend.	4 weeks, 12 weeks, and 26 weeks
Engagement With Program - Number of Times App Was Opened	Collected weekly during the first 12 weeks after enrollment: o Number of times app opened Average number of times the app was opened, cumulative over 12 weeks.	12 weeks
Engagement With Program - Number of Days App Was Opened	Collected weekly during the first 12 weeks after enrollment: o Number of days in which app was opened Average number of days the app was opened, cumulative over 12 weeks.	12 weeks
Engagement With Program - Number of Weeks App Was Opened	Collected weekly during the first 12 weeks after enrollment: o Number of weeks in which app was opened Average number of weeks the app was opened, cumulative over 12 weeks.	12 weeks
Participant Changes in Self-Efficacy	6-item Smoking Abstinence Self-efficacy Questionnaire (SASEQ) (Spek V, et al. Int.J. Behav. Med. (2013) 20:444-449). SASEQ score is on a scale of 0-24. Each of the 6 questions is answered on a 5-point Likert scale (0-4). Greater scores indicate greater self-efficacy toward quitting smoking.	12 weeks
Participant Changes in Self-Efficacy	6-item Smoking Abstinence Self-efficacy Questionnaire (SASEQ) (Spek V, et al. Int.J. Behav. Med. (2013) 20:444-449). SASEQ score is on a scale of 0-24. Each of the 6 questions is answered on a 5-point Likert scale (0-4). Greater scores indicate greater self-efficacy toward quitting smoking.	52 weeks
Participant Changes in Self-reported Health and Wellbeing	participant self-report, choices for reporting health: excellent, very good, good, fair, or poor	12 weeks
Self-Reported Nicotine Replacement Therapy (NRT) Use	Nicotine replacement therapy (NRT) use assessed with participant orders of NRT	26 weeks
Self-Reported Nicotine Replacement Therapy (NRT) Use	Nicotine replacement therapy (NRT) use assessed with participant orders of NRT	52 weeks
Adverse Events	participant self-report of adverse events and any issues experienced with assigned study app/program as well as the provided nicotine replacement therapy (NRT). For further adverse event details - see adverse event portion of this record.	12 weeks

Collaborators and Investigators

• Sponsor: Jennifer Marler, MD
• Investigators: Principal Investigator: Jennifer Marler, MD, Pivot Health Technologies Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: C-650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No