Trial Outcomes & Findings for Automated Mobile Contingency Management for Smoking Cessation: A Pilot RCT (SCC PREVAILgo) (NCT NCT03739437)
NCT ID: NCT03739437
Last Updated: 2023-04-04
Results Overview
Self-reported smoking abstinence during the past 7 days days
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
13 weeks post-enrollment
Results posted on
2023-04-04
Participant Flow
Participant milestones
| Measure |
Mobile Contingency Management
Mobile Contingency Management: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
Standard Care
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Mobile Contingency Management
Mobile Contingency Management: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
Standard Care
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
Baseline Characteristics
Automated Mobile Contingency Management for Smoking Cessation: A Pilot RCT (SCC PREVAILgo)
Baseline characteristics by cohort
| Measure |
Mobile Contingency Management
n=9 Participants
Mobile Contingency Management: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
Standard Care
n=11 Participants
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.33 Years
STANDARD_DEVIATION 10.04 • n=93 Participants
|
57.45 Years
STANDARD_DEVIATION 8.39 • n=4 Participants
|
55.60 Years
STANDARD_DEVIATION 9.16 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
11 participants
n=4 Participants
|
20 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 13 weeks post-enrollmentSelf-reported smoking abstinence during the past 7 days days
Outcome measures
| Measure |
Mobile Contingency Management
n=9 Participants
Mobile Contingency Management: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
Standard Care
n=11 Participants
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
|---|---|---|
|
Self-Reported Smoking Cessation
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 13 weeks post-enrollmentThe percentage of total possible smartphone-based breath sample submissions completed over 13 weeks.
Outcome measures
| Measure |
Mobile Contingency Management
n=819 Total Possible Breath Sample Submissions
Mobile Contingency Management: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
Standard Care
n=1001 Total Possible Breath Sample Submissions
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
|---|---|---|
|
Completion of Breath Sample Submissions
|
422 Breath samples submitted
|
566 Breath samples submitted
|
SECONDARY outcome
Timeframe: 13 weeks post-enrollmentPopulation: A total of 9 phones were provided to participants (all other participants used their own phones).
The total number of smartphones lost by participants during the study.
Outcome measures
| Measure |
Mobile Contingency Management
n=5 Participants
Mobile Contingency Management: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
Standard Care
n=4 Participants
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
|---|---|---|
|
Loss of Smartphones
|
2 Number of phones lost
|
1 Number of phones lost
|
SECONDARY outcome
Timeframe: 13 weeks post-enrollmentThe total number of iCO Sensors lost by participants during the study.
Outcome measures
| Measure |
Mobile Contingency Management
n=9 Participants
Mobile Contingency Management: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
Standard Care
n=11 Participants
Standard Care: Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
|
|---|---|---|
|
Loss of iCO Sensors
|
2 Number of iCOs lost
|
0 Number of iCOs lost
|
Adverse Events
Mobile Contingency Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
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
Dr. Darla Kendzor
The University of Oklahoma Health Sciences Center
Phone: (405) 271-8001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place