Trial Outcomes & Findings for A Quit Smoking Study Using Smartphones (NCT NCT02164383)
NCT ID: NCT02164383
Last Updated: 2019-04-03
Results Overview
Every day participants will report the number of cigarettes they smoked that day at baseline and for the first 4 weeks of the quit attempt (starting on the target quit day) using timeline followback assessment. This information will be used to calculate a participant's change in mean cigarettes smoked per day from baseline compared to the mean across the first 4 weeks of the quit attempt calculated as percentage change.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Cigarettes per day measured daily for the first 4 weeks of the quit attempt (starting on the target quit day) and at baseline
Results posted on
2019-04-03
Participant Flow
Participant milestones
| Measure |
Mobile Games
This arm of the project will address the following question:
How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
Mobile Games
|
No Mobile Games
This arm of the project will address the following question:
How effective is the following intervention:
Nicotine patch plus behavioral cessation counseling without access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Mobile Games
This arm of the project will address the following question:
How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
Mobile Games
|
No Mobile Games
This arm of the project will address the following question:
How effective is the following intervention:
Nicotine patch plus behavioral cessation counseling without access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Quit Smoking Study Using Smartphones
Baseline characteristics by cohort
| Measure |
Mobile Games
n=16 Participants
This arm of the project will address the following question:
How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
Mobile Games
|
No Mobile Games
n=14 Participants
This arm of the project will address the following question:
How effective is the following intervention:
Nicotine patch plus behavioral cessation counseling without access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.06 years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
43.79 years
STANDARD_DEVIATION 13.50 • n=7 Participants
|
40.73 years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cigarettes per day measured daily for the first 4 weeks of the quit attempt (starting on the target quit day) and at baselineEvery day participants will report the number of cigarettes they smoked that day at baseline and for the first 4 weeks of the quit attempt (starting on the target quit day) using timeline followback assessment. This information will be used to calculate a participant's change in mean cigarettes smoked per day from baseline compared to the mean across the first 4 weeks of the quit attempt calculated as percentage change.
Outcome measures
| Measure |
Mobile Games
n=16 Participants
This arm of the project will address the following question:
How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
Mobile Games
|
No Mobile Games
n=14 Participants
This arm of the project will address the following question:
How effective is the following intervention:
Nicotine patch plus behavioral cessation counseling without access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
|
|---|---|---|
|
Change Between Baseline Mean Cigarettes Smoked Per Day and Mean Cigarettes Smoked Per Day During the First 4 Weeks of the Quit Attempt Calculated as Percentage Change
|
-86.08 percentage change in cigarettes per day
Standard Deviation 22.06
|
-84.26 percentage change in cigarettes per day
Standard Deviation 30.03
|
Adverse Events
Mobile Games
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
No Mobile Games
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mobile Games
n=16 participants at risk
This arm of the project will address the following question:
How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
Mobile Games
|
No Mobile Games
n=14 participants at risk
This arm of the project will address the following question:
How effective is the following intervention:
Nicotine patch plus behavioral cessation counseling without access to Mobile Games.
Nicotine patch: 4-week starter kit of nicotine patch
Cessation Counseling: 5 brief counseling sessions
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin rash
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected 3 times during one month of treatment.
Participants were asked "Since your last contact with us, have there been any changes in your medical condition or health?" on the target quit day (TQD), 2 weeks post-TQD, and 4 weeks post-TQD. Only nicotine-related adverse events were counted. A total of 15 nicotine-related adverse events were assessed.
|
14.3%
2/14 • Number of events 3 • Adverse event data were collected 3 times during one month of treatment.
Participants were asked "Since your last contact with us, have there been any changes in your medical condition or health?" on the target quit day (TQD), 2 weeks post-TQD, and 4 weeks post-TQD. Only nicotine-related adverse events were counted. A total of 15 nicotine-related adverse events were assessed.
|
|
Skin and subcutaneous tissue disorders
Itching or hives
|
0.00%
0/16 • Adverse event data were collected 3 times during one month of treatment.
Participants were asked "Since your last contact with us, have there been any changes in your medical condition or health?" on the target quit day (TQD), 2 weeks post-TQD, and 4 weeks post-TQD. Only nicotine-related adverse events were counted. A total of 15 nicotine-related adverse events were assessed.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected 3 times during one month of treatment.
Participants were asked "Since your last contact with us, have there been any changes in your medical condition or health?" on the target quit day (TQD), 2 weeks post-TQD, and 4 weeks post-TQD. Only nicotine-related adverse events were counted. A total of 15 nicotine-related adverse events were assessed.
|
Additional Information
Tanya Schlam, PhD
University of Wisconsin Center for Tobacco Research and Intervention
Phone: 608-262-4149
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place