Trial Outcomes & Findings for Development of a mHealth Intervention for Ambivalent Smokers (NCT NCT04560868)
NCT ID: NCT04560868
Last Updated: 2023-01-23
Results Overview
Number of unique app user-sessions
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
Assessed at 3-month follow-up
Results posted on
2023-01-23
Participant Flow
Study enrollment began 12/16/2020 and study activities completed 9/27/21. Participants were recruited through two sources: (1) social media ads inviting individuals to email contact study staff to learn more and be screened for eligibility and (2) outreach to people our research waitlist.
Participant milestones
| Measure |
Control
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
Completed 1-month Self-report Survey
|
28
|
21
|
|
Overall Study
Completed 3-month Self-report Survey
|
26
|
21
|
|
Overall Study
Completed App Utilization Period
|
29
|
28
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of a mHealth Intervention for Ambivalent Smokers
Baseline characteristics by cohort
| Measure |
Control
n=29 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=28 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cigarettes per day
|
17.8 cigarettes/day
STANDARD_DEVIATION 6.6 • n=5 Participants
|
18.5 cigarettes/day
STANDARD_DEVIATION 8.7 • n=7 Participants
|
18.2 cigarettes/day
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
At least one quit attempt lasting a day or longer in the past 12 months
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
7-day point prevalence abstinence
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 3-month follow-upPopulation: All individuals who installed the app (n = 57).
Number of unique app user-sessions
Outcome measures
| Measure |
Control
n=29 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=28 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Program Engagement
|
7.3 User sessions
Standard Deviation 6.6
|
19.9 User sessions
Standard Deviation 16.2
|
PRIMARY outcome
Timeframe: Assessed at 3-month follow-upPopulation: All individuals who installed the app (n = 57).
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
Outcome measures
| Measure |
Control
n=29 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=28 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Quit Attempt Lasting at Least 24 Hours
|
11 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Assessed at 3-month follow-upPopulation: All individuals who installed the app (n = 57).
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.
Outcome measures
| Measure |
Control
n=29 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=28 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Not Smoking (Even a Puff) in the Last 7 Days
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Assessed at 1 monthPopulation: Responses were assessed among participants who earned at least one utilization badge by the one-month survey. This ensured participants had sufficient interaction with the app to rate their satisfaction with it.
Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
Outcome measures
| Measure |
Control
n=25 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=19 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Satisfaction With Assigned App
|
3.6 score on a scale
Standard Deviation 1.2
|
3.8 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Assessed at 3 monthsPopulation: Responses were assessed among participants who earned at least one utilization badge by the three-month survey. This was done to ensure participants had sufficient interaction with the app to rate their satisfaction with it.
Satisfaction with the overall "content and advice" of the assigned app on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
Outcome measures
| Measure |
Control
n=23 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=20 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Satisfaction With Assigned App
|
4.0 score on a scale
Standard Deviation 1.1
|
4.0 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Assessed at 1 month.Population: Participants who installed the app, self-reported use of all rated features, rated each feature on follow-up survey, and were confirmed via automated data to have used the app features.
Global helpfulness rating calculated as the average helpfulness rating of 8 app features, each rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".
Outcome measures
| Measure |
Control
n=7 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=5 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Helpfulness of Assigned App
|
3.2 average scores on a scale
Standard Deviation 1.2
|
3.8 average scores on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Assessed at 3 monthsPopulation: Individuals who installed the app, responded to questions about helpfulness of each rated feature, self-reported use of each app feature, and based on automated data had sufficient use of the app features to rate their helpfulness at follow-up.
Average helpfulness rating of 8 separate app features, with each feature rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".
Outcome measures
| Measure |
Control
n=5 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=5 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Helpfulness of Assigned App
|
3.1 average scores on a scale
Standard Deviation 0.6
|
3.6 average scores on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Assessed at 1-month follow-upPopulation: All individuals who installed the app (n = 57).
Number of accumulated badge rewards earned from using the assigned app.
Outcome measures
| Measure |
Control
n=29 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=28 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Program Engagement - Earned Badges
|
5.7 badges
Standard Deviation 3.7
|
8.6 badges
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Assessed at 3-month follow-upPopulation: Includes all individuals who installed the app. Everyone used the app at least once.
Number of accumulated badge rewards earned from using the assigned app.
Outcome measures
| Measure |
Control
n=29 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=28 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Program Engagement - Earned Badges
|
6.1 Badges
Standard Deviation 3.5
|
10.1 Badges
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Assessed at 1 monthPopulation: Respondents to the assessed question, which was only asked to those still smoking at follow-up and had installed the app.
Self-reported confidence in quitting smoking on Likert scale from 1="not at all" to 10="extremely".
Outcome measures
| Measure |
Control
n=27 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=20 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Self-efficacy to Quit Smoking
|
7.5 score on a scale
Standard Deviation 2.3
|
7.4 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Assessed at 3 monthsPopulation: Respondents to the assessed question, which was only asked among individuals who were still smoking at follow-up and had installed the app.
Self-reported confidence in quitting smoking on a Likert scale from 1="not at all" to 10="extremely".
Outcome measures
| Measure |
Control
n=23 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=17 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Self-efficacy to Quit Smoking
|
7.9 score on a scale
Standard Deviation 2.1
|
6.8 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Assessed at 1 monthPopulation: Respondents to a question only asked among participants who installed the app and reported they had not smoked in the past 7 days.
Self-reported confidence in ability to stay quit on a Likert scale from 1="not at all" to 10="extremely".
Outcome measures
| Measure |
Control
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=1 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Self-efficacy to Stay Quit
|
—
|
6 score on a scale
Standard Deviation NA
The Overall Number of Participants Analyzed is 1, so the Standard Deviation was not calculated.
|
SECONDARY outcome
Timeframe: Assessed at 3 monthsPopulation: Respondents to question asked among individuals who installed the app and reported not smoking in the past 7 days at 3 month follow-up.
Self-reported confidence in ability to stay quit (if no smoking in the past 7 days) on a Likert scale from 1="not at all" to 10="extremely".
Outcome measures
| Measure |
Control
n=1 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=2 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Self-efficacy to Stay Quit
|
10 score on a scale
Standard Deviation NA
The Overall Number of Participants Analyzed is 1, so the Standard Deviation was not calculated.
|
9 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Assessed at 1-month follow-upPopulation: All individuals who installed the app (n = 57).
Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Outcome measures
| Measure |
Control
n=29 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=28 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Earned and Requested Free Nicotine Replacement Therapy
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Assessed at 3-month follow-upPopulation: Individuals who installed the app (n = 57). Note that free NRT is earned when 6 utilization badges have been earned.
Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Outcome measures
| Measure |
Control
n=29 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=28 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Earned and Requested Free Nicotine Replacement Therapy
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Assessed at 1 month follow-upPopulation: Individuals who installed the app (n = 57).
At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt.
Outcome measures
| Measure |
Control
n=29 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=28 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Quit Attempt Lasting at Least 24 Hours
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Assessed at baseline and 1 monthPopulation: Individuals who installed the app, returned the 1-month survey, and either responded to this item or reported not smoking in the past 7 days. If they reported not smoking for the past 7 days, number of cigarettes were day were coded as 0.
Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline.
Outcome measures
| Measure |
Control
n=27 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=21 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Change in Cigarettes/Day
Baseline 30-day average cigarettes/day
|
17.9 Cigarettes/day
Standard Deviation 6.8
|
17.6 Cigarettes/day
Standard Deviation 8.2
|
|
Change in Cigarettes/Day
Change from baseline in number of cigarettes/day at 1 month (using one-month 7-day average)
|
-5.1 Cigarettes/day
Standard Deviation 5.2
|
-3.6 Cigarettes/day
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Assessed at baseline and 3 monthsPopulation: Individuals who installed the app, returned the 3-month survey, and either responded to this item or reported not smoking in the past 7 days. If they reported not smoking for the past 7 days, number of cigarettes were day were coded as 0.
Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline.
Outcome measures
| Measure |
Control
n=25 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=21 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Change in Cigarettes/Day
Baseline 30-day average cigarettes/day
|
17.6 Cigarettes/day
Standard Deviation 6.9
|
17.9 Cigarettes/day
Standard Deviation 8.0
|
|
Change in Cigarettes/Day
Change in daily average cigarettes/day between baseline and three-month (using 7-day average)
|
-6.7 Cigarettes/day
Standard Deviation 7.9
|
-5.2 Cigarettes/day
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Assessed at 1-month follow-upPopulation: Individuals who installed the app (n = 57).
7-day point prevalent abstinence: a self-report of not smoking, even a puff, in the past 7 days. Missing outcomes were imputed as smoking.
Outcome measures
| Measure |
Control
n=29 Participants
Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
Experimental
n=28 Participants
Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
|
|---|---|---|
|
Refrain From Smoking (Even a Puff) in the Last 7 Days
|
0 Participants
|
1 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Investigative Science
Kaiser Permanente Washington Health Research Institute
Phone: 206-287-2737
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place