Trial Outcomes & Findings for Pro-Change Smoking Cessation Intervention (NCT NCT02299076)
NCT ID: NCT02299076
Last Updated: 2017-10-02
Results Overview
Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
422 participants
Primary outcome timeframe
Every 30 days for up to 6 months post-enrollment
Results posted on
2017-10-02
Participant Flow
Recruitment period: January to March, 2016. Recruitment methods: Physician and nurse referrals from Rhode Island Primary Care Physicians Corporation and Facebook advertisements. Intake method: Digital intake form hosted by Pro-Change.
We identified and discontinued 34 participants whose accounts were were flagged as being suspicious. Duplicate accounts were erroneously created by a participant and thus were removed from the study. Suspicious accounts contained personal information identical to existing participants and after investigation, were concluded to be fraudulent.
Participant milestones
| Measure |
Usual Care With Minimal Incentives
Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.
Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention.
|
Usual Care With BE Incentives
Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.
Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
226
|
|
Overall Study
COMPLETED
|
210
|
212
|
|
Overall Study
NOT COMPLETED
|
20
|
14
|
Reasons for withdrawal
| Measure |
Usual Care With Minimal Incentives
Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.
Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention.
|
Usual Care With BE Incentives
Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.
Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention.
|
|---|---|---|
|
Overall Study
Fraudulent Entries
|
20
|
14
|
Baseline Characteristics
Pro-Change Smoking Cessation Intervention
Baseline characteristics by cohort
| Measure |
Usual Care With Minimal Incentives
n=210 Participants
Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.
Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention.
|
Usual Care With BE Incentives
n=212 Participants
Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.
Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention.
|
Total
n=422 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
44 years
n=7 Participants
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
196 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
384 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
210 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 30 days for up to 6 months post-enrollmentEngagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant.
Outcome measures
| Measure |
Usual Care With Minimal Incentives
n=343 Sessions
Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.
Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention.
|
Usual Care With BE Incentives
n=647 Sessions
Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.
Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention.
|
|---|---|---|
|
Average Number of Completed Sessions Per Participant
|
1.633 Average Number of Sessions
Interval 1.0 to 2.0
|
3.052 Average Number of Sessions
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: Every 30 days for up to 6 months post-enrollmentQuit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program.
Outcome measures
| Measure |
Usual Care With Minimal Incentives
n=210 Participants
Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.
Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention.
|
Usual Care With BE Incentives
n=212 Participants
Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.
Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention.
|
|---|---|---|
|
Outcome of Smoking Cessation Intervention
|
38 Participants
|
63 Participants
|
Adverse Events
Usual Care With Minimal Incentives
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care With BE Incentives
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place