Cigarette Smoking-Related Carcinoma
Conditions
Brief summary
This phase I trial investigates a new smartphone application (called Actify) for improving population-level smoking cessation and mood management. Actify delivers behavioral activation therapy for depression as part of a smoking cessation intervention and will be compared to another smoking cessation smartphone application that is based on current clinical practice guidelines. Participants will be randomly assigned to receive one of two smartphone applications and accompanying text notifications to help with quitting smoking and improved mood.
Detailed description
OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. ARM II: Participants use United States (US) Clinical Practice Guidelines (USCPG) app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. After completion of study, participants are followed up at 6 months.
Interventions
OTHERHealth Promotion and Education
Receive motivational messages and smoking cessation information via text notifications
BEHAVIORALSmoking Cessation Intervention (Actify app)
Use Actify app
BEHAVIORALSmoking Cessation Intervention (Current Standard Care app)
Use (USCPG) Current Standard Care app
OTHERSurvey Administration
Ancillary studies
Sponsors
National Institute on Drug Abuse (NIDA)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Any outcome evaluator who has direct contact with participants will be blinded to treatment group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current smoker, averaging at least 5 cigarettes/day for the last 30 days * Interested in quitting smoking in the next 30 days * Experience downloading and using one or more apps on their smartphone * Either screens negative (Patient Health Questionnaire - 9 Item \[PHQ-9\] score 0-4) for depression or screens positive for mild to moderate current depressive symptoms (PHQ-9 score 5-19) * Willing and able to complete all study activities * Comfortable reading and writing in English * Have a mobile data plan and/or access to WiFi to support the use of the Actify app * Reside in the US * Have a smartphone either an iPhone (running iOS version 11 or higher) or an Android phone (running version 5.0 or higher)
Exclusion criteria
* Currently receiving behavioral treatment for depression (e.g., psychotherapy) * Current use of a depression app * Severe depression (PHQ-9 \>= 20) * Receiving other treatment for smoking cessation * Previous use of the QuitGuide app * Current or recent (within the past year) enrollment in a Fred Hutch smoking cessation study * Employees/family of investigator or study center * Member of the same household as another participant * Woman who is pregnant or breastfeeding, or planning to become pregnant * Currently incarcerated * Is ineligible per fraud prevention protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey | At 8 weeks post-randomization | Overall treatment satisfaction is reported on a Likert-type scale, with response choices ranging from not at all=1 to very much=5. Higher values are associated with higher level of satisfaction. |
| Application (App) Utilization | At 8 weeks post-randomization | Number of app openings during the 8-week treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 7-day PPA From Smoking | At 8 weeks post-randomization | Self-reported 7-day abstinence on the survey question of When was the last time you smoked, or even tried, a cigarette? |
| Biochemically Confirmed 7-day PPA From Smoking | At 8 weeks post-randomization | Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO \< 6ppm) |
| Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | At 8 weeks post-randomization | Self-reported 30-day abstinence on the survey questions of Have you smoked at all, even a puff, in the last 30 days? & In the last 30 days, how often did you use any kind of e-cigarette or vaping product? & In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks? |
| Biochemically-confirmed 30-day PPA From Smoking | At 8 weeks post-randomization | Self-reported 30-day smoking abstinence at 8 weeks, confirmed via expired carbon monoxide (CO\<6ppm) |
| Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8) | Baseline to 8 weeks | The Patient Health Questionnaire-8 (PHQ-8) is an assessment of depressive symptoms used to detect symptom changes over time as a result of treatment. The PHQ-8 asks the number of days in the past 2 weeks the respondent had experienced a particular depressive symptom. Possible answers are not at all or several days or more than half the days or nearly every day, with points (0 to 3) assigned to each category. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. |
| Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking | At 8 weeks post-randomization | Self-reported 30-day abstinence on the survey question of Have you smoked at all, even a puff, in the last 30 days? |
| Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS) | Baseline to 8 weeks post-randomization | The Behavioral Activation for Depression Scale (BADS) is a 25-item scale used to track changes in behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. BADS items are rated on a 7-point scale ranging from 0 (not at all) to 6 (completely). The behavioral activation subscale contains 7 items, with a scoring range of 0 to 42. Change scores reflect the value of the BADS behavioral activation subscale score at 8-week follow-up minus the baseline score. Positive change values indicate an increase in behavioral activation (i.e, an improvement), whereas negative scores indicate a decrease in behavioral activation. |
| Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | At 8 weeks post-randomization | Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO \< 6ppm) |
| Self-reported 30-day PPA From Smoking | At 6 months post-randomization | Self-reported 30-day abstinence on the survey question of Have you smoked at all, even a puff, in the last 30 days? |
Countries
United States
Participant flow
Recruitment details
Two-hundred forty two participants were eligible and enrolled in the study. The final sample comprised 242 participants who were randomized between May 9, 2022 and September 30, 2022.
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Actify, Text Notifications) Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications
Smoking Cessation Intervention (Actify app): Use Actify app
Survey Administration: Ancillary studies | 119 |
| Arm II (Current Standard Care, Text Notifications) Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications
Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app
Survey Administration: Ancillary studies | 123 |
| Total | 242 |
Baseline characteristics
| Characteristic | Arm I (Actify, Text Notifications) | Total | Arm II (Current Standard Care, Text Notifications) |
|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 11 | 50.3 years STANDARD_DEVIATION 10.5 | 52 years STANDARD_DEVIATION 9.8 |
| Cigarettes per Day in the past 30 days) | 18 cigarettes per day STANDARD_DEVIATION 7.7 | 19.1 cigarettes per day STANDARD_DEVIATION 10.9 | 20.2 cigarettes per day STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 13 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 112 Participants | 229 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mental Health Condition - Anxiety, Depression, Bipolar, Schizophrenia, Alcohol or Drug Abuse | 23 Participants | 57 Participants | 34 Participants |
| No Mental Health Condition | 96 Participants | 185 Participants | 89 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 38 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) White | 95 Participants | 181 Participants | 86 Participants |
| Sex: Female, Male Female | 83 Participants | 167 Participants | 84 Participants |
| Sex: Female, Male Male | 36 Participants | 75 Participants | 39 Participants |
| Smoking Level (in the past 30 days) - High (20+ CIgs/Day) | 64 Participants | 130 Participants | 66 Participants |
| Smoking Level (in the past 30 days) - Low (<20 Cigs/Day) | 55 Participants | 112 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 123 |
| other Total, other adverse events | 0 / 119 | 0 / 123 |
| serious Total, serious adverse events | 0 / 119 | 0 / 123 |
Outcome results
Primary
Application (App) Utilization
Number of app openings during the 8-week treatment period.
Time frame: At 8 weeks post-randomization
Population: We used negative binomial regression adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), and Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5) to compare number of app openings by treatment arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Application (App) Utilization | 34.3 app openings | Standard Deviation 33.7 |
| Arm II (Current Standard Care, Text Notifications) | Application (App) Utilization | 34.3 app openings | Standard Deviation 39.4 |
p-value: 0.7595% CI: [-15.22, 21.07]Negative Binomial Regression
Primary
Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey
Overall treatment satisfaction is reported on a Likert-type scale, with response choices ranging from not at all=1 to very much=5. Higher values are associated with higher level of satisfaction.
Time frame: At 8 weeks post-randomization
Population: Overall number of participants analyzed include those who opened the app at least once AND answered at least one acceptability question in the 8 week follow-up survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey | 4.1 units on a scale | Standard Deviation 1 |
| Arm II (Current Standard Care, Text Notifications) | Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey | 3.7 units on a scale | Standard Deviation 1.1 |
Comparison: Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from not at all to very much. We used a linear regression adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), and Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5) to test for differences between arms.p-value: 0.008895% CI: [0.1, 0.74]Regression, Linear
Secondary
Biochemically-confirmed 30-day PPA From Smoking
Self-reported 30-day smoking abstinence at 8 weeks, confirmed via expired carbon monoxide (CO\<6ppm)
Time frame: At 8 weeks post-randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Biochemically-confirmed 30-day PPA From Smoking | No Quit | 109 participants |
| Arm I (Actify, Text Notifications) | Biochemically-confirmed 30-day PPA From Smoking | Quit | 10 participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically-confirmed 30-day PPA From Smoking | No Quit | 115 participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically-confirmed 30-day PPA From Smoking | Quit | 8 participants |
p-value: 0.5595% CI: [0.5, 3.48]Regression, Logistic
Secondary
Biochemically-confirmed 30-day PPA From Smoking
Self-reported 30-day smoking abstinence at 6 months, confirmed via expired carbon monoxide (CO\<6 ppm)
Time frame: At 6 months post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Biochemically-confirmed 30-day PPA From Smoking | No Quit | 104 Participants |
| Arm I (Actify, Text Notifications) | Biochemically-confirmed 30-day PPA From Smoking | Quit | 15 Participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically-confirmed 30-day PPA From Smoking | No Quit | 113 Participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically-confirmed 30-day PPA From Smoking | Quit | 10 Participants |
p-value: 0.2595% CI: [0.7, 3.81]Regression, Logistic
Secondary
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO \< 6ppm)
Time frame: At 6 months post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | No Quit | 107 Participants |
| Arm I (Actify, Text Notifications) | Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | Quit | 12 Participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | No Quit | 115 Participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | Quit | 8 Participants |
p-value: 0.395% CI: [0.63, 4.19]Regression, Logistic
Secondary
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO \< 6ppm)
Time frame: At 8 weeks post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | No Quit | 112 Participants |
| Arm I (Actify, Text Notifications) | Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | Quit | 7 Participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | No Quit | 117 Participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | Quit | 6 Participants |
p-value: 0.6895% CI: [0.41, 3.86]Regression, Logistic
Secondary
Biochemically Confirmed 7-day PPA From Smoking
Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO \< 6ppm)
Time frame: At 6 months post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Biochemically Confirmed 7-day PPA From Smoking | No Quit | 103 Participants |
| Arm I (Actify, Text Notifications) | Biochemically Confirmed 7-day PPA From Smoking | Quit | 16 Participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically Confirmed 7-day PPA From Smoking | No Quit | 113 Participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically Confirmed 7-day PPA From Smoking | Quit | 10 Participants |
p-value: 0.1795% CI: [0.77, 4.12]Regression, Logistic
Secondary
Biochemically Confirmed 7-day PPA From Smoking
Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO \< 6ppm)
Time frame: At 8 weeks post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Biochemically Confirmed 7-day PPA From Smoking | Quit | 17 Participants |
| Arm I (Actify, Text Notifications) | Biochemically Confirmed 7-day PPA From Smoking | No Quit | 102 Participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically Confirmed 7-day PPA From Smoking | Quit | 8 Participants |
| Arm II (Current Standard Care, Text Notifications) | Biochemically Confirmed 7-day PPA From Smoking | No Quit | 115 Participants |
p-value: 0.0495% CI: [1, 5.85]Regression, Logistic
Secondary
Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS)
The Behavioral Activation for Depression Scale (BADS) is a 25-item scale used to track changes in behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. BADS items are rated on a 7-point scale ranging from 0 (not at all) to 6 (completely). The behavioral activation subscale contains 7 items, with a scoring range of 0 to 42. Change scores reflect the value of the BADS behavioral activation subscale score at 8-week follow-up minus the baseline score. Positive change values indicate an increase in behavioral activation (i.e, an improvement), whereas negative scores indicate a decrease in behavioral activation.
Time frame: Baseline to 8 weeks post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS) | -2.4 score on a scale | Standard Deviation 9.6 |
| Arm II (Current Standard Care, Text Notifications) | Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS) | .8 score on a scale | Standard Deviation 8.9 |
p-value: 0.002595% CI: [1.28, 5.95]Regression, Linear
Secondary
Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8)
The Patient Health Questionnaire-8 (PHQ-8) is an assessment of depressive symptoms used to detect symptom changes over time as a result of treatment. The PHQ-8 asks the number of days in the past 2 weeks the respondent had experienced a particular depressive symptom. Possible answers are not at all or several days or more than half the days or nearly every day, with points (0 to 3) assigned to each category. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.
Time frame: Baseline to 8 weeks
Population: Follow-up score minus baseline score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8) | .7 units on a scale | Standard Deviation 4.2 |
| Arm II (Current Standard Care, Text Notifications) | Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8) | 2.2 units on a scale | Standard Deviation 5.2 |
p-value: 0.007295% CI: [-2.9, -0.46]Regression, Linear
Secondary
Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking
Self-reported 30-day abstinence on the survey question of Have you smoked at all, even a puff, in the last 30 days?
Time frame: At 8 weeks post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking | No Quit | 104 Participants |
| Arm I (Actify, Text Notifications) | Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking | Quit | 15 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking | No Quit | 114 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking | Quit | 9 Participants |
p-value: 0.17795% CI: [0.77, 4.344]Regression, Logistic
Secondary
Self-reported 30-day PPA From Smoking
Self-reported 30-day abstinence on the survey question of Have you smoked at all, even a puff, in the last 30 days?
Time frame: At 6 months post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Self-reported 30-day PPA From Smoking | No Quit | 97 Participants |
| Arm I (Actify, Text Notifications) | Self-reported 30-day PPA From Smoking | Quit | 22 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 30-day PPA From Smoking | No Quit | 108 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 30-day PPA From Smoking | Quit | 15 Participants |
p-value: 0.1795% CI: [0.8, 3.32]Regression, Logistic
Secondary
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Self-reported 30-day abstinence on survey questions of Have you smoked at all, even a puff, in the last 30 days? & In the last 30 days, how often did you use any kind of e-cigarette or vaping product? & In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks?
Time frame: At 6 months post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | Quit | 19 Participants |
| Arm I (Actify, Text Notifications) | Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | No Quit | 100 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | No Quit | 110 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | Quit | 13 Participants |
p-value: 0.2195% CI: [0.75, 3.46]Regression, Logistic
Secondary
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Self-reported 30-day abstinence on the survey questions of Have you smoked at all, even a puff, in the last 30 days? & In the last 30 days, how often did you use any kind of e-cigarette or vaping product? & In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks?
Time frame: At 8 weeks post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | No Quit | 105 Participants |
| Arm I (Actify, Text Notifications) | Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | Quit | 14 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | No Quit | 115 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes | Quit | 8 Participants |
p-value: 0.1595% CI: [0.77, 4.73]Regression, Logistic
Secondary
Self-reported 7-day PPA From Smoking
Self-reported 7-day abstinence on the survey question of When was the last time you smoked, or even tried, a cigarette?
Time frame: At 6 months post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Self-reported 7-day PPA From Smoking | No Quit | 95 Participants |
| Arm I (Actify, Text Notifications) | Self-reported 7-day PPA From Smoking | Quit | 24 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 7-day PPA From Smoking | No Quit | 105 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 7-day PPA From Smoking | Quit | 18 Participants |
p-value: 0.2595% CI: [0.75, 2.89]Regression, Logistic
Secondary
Self-reported 7-day PPA From Smoking
Self-reported 7-day abstinence on the survey question of When was the last time you smoked, or even tried, a cigarette?
Time frame: At 8 weeks post-randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Actify, Text Notifications) | Self-reported 7-day PPA From Smoking | No Quit | 93 Participants |
| Arm I (Actify, Text Notifications) | Self-reported 7-day PPA From Smoking | Quit | 26 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 7-day PPA From Smoking | No Quit | 107 Participants |
| Arm II (Current Standard Care, Text Notifications) | Self-reported 7-day PPA From Smoking | Quit | 16 Participants |
p-value: 0.0795% CI: [0.94, 3.72]Regression, Logistic