Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | A commercially available mobile phone app and program |
|
| Pivot | Active Comparator | Pivot mobile phone app and program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | Standard of Care - Control Smoking Cessation Program |
|
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Marler, MD | Pivot Health Technologies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pivot Health Technologies, Inc. | San Carlos | California | 94070 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37585282 | Derived | Marler JD, Fujii CA, Utley MT, Balbierz DJ, Galanko JA, Utley DS. Long-Term Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Sep 18;11:e48157. doi: 10.2196/48157. | |
| 36257323 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program |
| FG001 | Pivot | Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program |
| BG001 | Pivot | Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | app openings | 12 weeks |
|
Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI upset due to NRT lozenge or gum use | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Fujii, Sr. Director of Clinical Affairs and Data Science | Pivot Health Technologies Inc. | 650-906-4255 | craig@pivot.co |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2023 | Dec 14, 2023 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
1:1 randomization
Not provided
Not provided
Participant blinded to arm assignment but not to the smoking cessation program he/she is using.
| Pivot | Other | Pivot Program Smoking Cessation Program |
|
|
| 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 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Self-reported health | Count of Participants | Participants |
|
| Cigarettes per day | Mean | Standard Deviation | Cigarettes per day |
|
| Years smoking | Mean | Standard Deviation | years |
|
| Tobacco products used | Count of Participants | Participants |
|
| Difficulty to Quit (DTQ) | Difficulty to Quit (DTQ) = If you were to quit smoking right now, how difficult do you think it would be to stay smoke-free? (1 = Really hard to stay quit, 10 = Really easy to stay quit) | Mean | Standard Deviation | score on a scale |
|
| Success to Quit (STQ) | Success to Quit (STQ): If you were to quit smoking right now, how successful would you be? (1 = not at all successful; 10 = completely successful) | Mean | Standard Deviation | score on a scale |
|
| Smoking Abstinence Self-Efficacy Questionnaire (SASEQ) | Smoking Abstinence Self-Efficacy Questionnaire (SASEQ) is a 6-question questionnaire answered on a 5-point Likert scale (0-4) that results in a score from 0-24. A lower score represents lower self-efficacy in regards to quitting smoking, while a higher score represents greater self-efficacy in regards to quitting smoking. | Mean | Standard Deviation | score on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Desire to Quit (Yes/no) | desire to quit smoking, participant self-report, yes/no | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Self-Reported Smoking Abstinence | participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Self-Reported Smoking Abstinence | participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 26 week questionnaire. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | Self-Reported Smoking Abstinence | participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 52 week questionnaire. | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
| Secondary | 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 | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 12 week questionnaire. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | 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. | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 26 week questionnaire. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | 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. | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 52 week questionnaire. | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
| Secondary | 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. | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 12 week questionnaire. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | 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. | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 26 week questionnaire. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | 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. | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 52 week questionnaire. | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
| Secondary | 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. | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 26 week questionnaire. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | 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. | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 52 week questionnaire. | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
| Secondary | 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. | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 26 week questionnaire. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | 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. | Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses. ITT includes entire study population from the study arm, while responder only includes participants who completed the 52 week questionnaire. | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
| Secondary | Proportion With ≥ 50% CPD Reduction | The proportion of participants who reduced their cigarettes per day (CPD) by ≥ 50% compared to baseline | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | 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". | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | 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". | Participants that completed the 3 week questionnaire | Posted | Count of Participants | Participants | 3 weeks |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | 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). | Number of participants differs per question: Only participants reporting 7-day PPA (n=25 control, n=34 Pivot) were asked if their study program helped them quit smoking. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | 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). | Only participants reporting 7-day PPA at 52 weeks (n=29 control, n=39 Pivot) were asked if their study program helped them quit smoking. | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
| Secondary | 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. | Number analyzed differs based on differential completion of the surveys at each of the timepoints: 4 weeks, 12 weeks, and 26 weeks | Posted | Number | score on a scale | 4 weeks, 12 weeks, and 26 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | number of app openings | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | days | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | weeks | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
|
|
|
| Secondary | Participant Changes in Self-reported Health and Wellbeing | participant self-report, choices for reporting health: excellent, very good, good, fair, or poor | Participant numbers are different from baseline to week 26 due to 4 participants from each arm not completing the week 16 questionnaire | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Self-Reported Nicotine Replacement Therapy (NRT) Use | Nicotine replacement therapy (NRT) use assessed with participant orders of NRT | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | Self-Reported Nicotine Replacement Therapy (NRT) Use | Nicotine replacement therapy (NRT) use assessed with participant orders of NRT | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 17 |
| 94 |
| EG001 | Pivot | Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program | 0 | 94 | 0 | 94 | 19 | 94 |
| Skin irritation due to NRT patch use | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Heartburn due to NRT lozenge or gum use | Gastrointestinal disorders | Systematic Assessment |
|
| Sleep issues - wild dreams, insomnia | General disorders | Systematic Assessment |
|
| Headache due to NRT use | General disorders | Systematic Assessment |
|
| Hiccups due to NRT lozenge or gum use | Gastrointestinal disorders | Systematic Assessment |
|
| Jittery, racing heart, or lightheaded feeling due to NRT use | General disorders | Systematic Assessment |
|
| Mouth irritation or sore throat due to NRT lozenge or gum use | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| 7-day PPA at 26 weeks Responder |
|
|
| 30-day PPA at 26 weeks ITT |
|
|
| 30-day PPA at 26 weeks Responder |
|
|
| 7-day PPA at 52 weeks Responder |
|
|
| 30-day PPA at 52 weeks ITT |
|
|
| 30-day PPA at 52 weeks Responder |
|
|
| Self-report no tobacco use Responder |
|
|
| Self-report no tobacco use Responder |
|
|
| Self-report no tobacco use Responder |
|
|
| Biovalidated abstinence Responder |
|
|
| Biovalidated abstinence Responder |
|
|
| Biovalidated abstinence Responder |
|
|
| Self-reported continuous abstinence Responder |
|
|
| Self-reported continuous abstinence Responder |
|
|
| Biochemically confirmed continuous abstinence Responder |
|
|
| Biochemically confirmed continuous abstinence Responder |
|
|
| decreased |
|
| How has using your assigned program affected the number of cigarettes you smoke per day? |
|
| I have not learned anything from the program |
|
| I am more confused after using the program |
|
| Among participants reporting 7-day PPA: study program helped them quit smoking - answered "true" |
|
|
| NPS score at 12 weeks |
|
|
| NPS score at 26 weeks |
|
|
| Very good |
|
| Good |
|
| Fair |
|
| Poor |
|
| Self-reported health at 12 weeks |
|
|
| ≥1 NRT single-therapy order + ≥1 NRT combination-therapy order |
|
| No orders |
|
| ≥1 NRT single therapy + ≥1 NRT combination therapy order |
|
| None |
|