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

• ClinicalTrials.gov Identifier: NCT04955639
• Recruitment Status: Completed
• First Posted: July 9, 2021
• Results First Posted: January 5, 2024
• Last Update Posted: January 5, 2024
• Sponsor: Jennifer Marler, MD
• Information provided by (Responsible Party): Jennifer Marler, MD, Pivot Health Technologies Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Other: Control; Other: Pivot	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 188 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 1:1 randomization
• Masking: Single (Participant)
• Masking Description: Participant blinded to arm assignment but not to the smoking cessation program he/she is using.
• Primary Purpose: Other
• Official Title: Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program
• Actual Study Start Date: June 3, 2021
• Actual Primary Completion Date: April 27, 2022
• Actual Study Completion Date: November 17, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Average Total App Openings at 12 Weeks [ Time Frame: 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.

Secondary Outcome Measures :

1. Desire to Quit (Yes/no) [ Time Frame: 4 weeks ]
   desire to quit smoking, participant self-report, yes/no
2. Change in Expected Difficulty in Staying Quit [ Time Frame: 12 weeks ]
   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)
3. Change in Confidence Levels Towards Quitting Smoking [ Time Frame: 12 weeks ]
   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).
4. Self-Reported Smoking Abstinence [ Time Frame: 12 weeks ]
   participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes
5. Self-Reported Smoking Abstinence [ Time Frame: 26 weeks ]
   participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes
6. Self-Reported Smoking Abstinence [ Time Frame: 52 weeks ]
   participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes
7. Self-Reported Abstinence From All Tobacco Products [ Time Frame: 12 weeks ]
   participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah
8. Self-Reported Abstinence From All Tobacco Products [ Time Frame: 26 weeks ]
   Participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah.
9. Self-Reported Abstinence From All Tobacco Products [ Time Frame: 52 weeks ]
   Participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah.
10. Biochemically Confirmed Abstinence [ Time Frame: 12 weeks ]
    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.
11. Biochemically Confirmed Abstinence [ Time Frame: 26 weeks ]
    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.
12. Biochemically Confirmed Abstinence [ Time Frame: 52 weeks ]
    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.
13. Self-Reported Continuous Abstinence [ Time Frame: 26 weeks ]
    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.
14. Self-Reported Continuous Abstinence [ Time Frame: 52 weeks ]
    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.
15. Biochemically Confirmed Continuous Abstinence [ Time Frame: 26 weeks ]

    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.

16. Biochemically Confirmed Continuous Abstinence [ Time Frame: 52 weeks ]

    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.

17. Proportion With ≥ 50% CPD Reduction [ Time Frame: 26 weeks ]
    The proportion of participants who reduced their cigarettes per day (CPD) by ≥ 50% compared to baseline
18. User Satisfaction - User Feedback [ Time Frame: 2 weeks ]
    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".
19. Additional User Feedback [ Time Frame: 3 weeks ]
    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".
20. User Feedback - Setup and Starting the Program [ Time Frame: 12 weeks ]
    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)
21. User Feedback [ Time Frame: 26 weeks ]
    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).
22. User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking [ Time Frame: 52 weeks ]
    User feedback with the smoking cessation program, specifically whether the program helped them quit smoking (true/false).
23. User Satisfaction - Net Promoter Score (NPS) [ Time Frame: 4 weeks, 12 weeks, and 26 weeks ]

    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.

24. Engagement With Program - Number of Times App Was Opened [ Time Frame: 12 weeks ]

    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.

25. Engagement With Program - Number of Days App Was Opened [ Time Frame: 12 weeks ]

    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.

26. Engagement With Program - Number of Weeks App Was Opened [ Time Frame: 12 weeks ]

    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.

27. Participant Changes in Self-Efficacy [ Time Frame: 12 weeks ]

    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.

28. Participant Changes in Self-Efficacy [ Time Frame: 52 weeks ]

    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.

29. Participant Changes in Self-reported Health and Wellbeing [ Time Frame: 12 weeks ]
    participant self-report, choices for reporting health: excellent, very good, good, fair, or poor
30. Self-Reported Nicotine Replacement Therapy (NRT) Use [ Time Frame: 26 weeks ]
    Nicotine replacement therapy (NRT) use assessed with participant orders of NRT
31. Self-Reported Nicotine Replacement Therapy (NRT) Use [ Time Frame: 52 weeks ]
    Nicotine replacement therapy (NRT) use assessed with participant orders of NRT
32. Adverse Events [ Time Frame: 12 weeks ]
    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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, California

Pivot Health Technologies, Inc.

San Carlos, California, United States, 94070

Sponsors and Collaborators

Jennifer Marler, MD

Investigators

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

  Study Documents (Full-Text)

Documents provided by Jennifer Marler, MD, Pivot Health Technologies Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] April 25, 2023

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jennifer Marler, MD, Sr. Dir., Clinical and Medical Affairs, Pivot Health Technologies Inc.
• ClinicalTrials.gov Identifier: NCT04955639
• Other Study ID Numbers: C-650
• First Posted: July 9, 2021
• Results First Posted: January 5, 2024
• Last Update Posted: January 5, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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