Trial Outcomes & Findings for Worksite Phone Counseling for Smoking Cessation (NCT NCT02730260)
NCT ID: NCT02730260
Last Updated: 2016-12-23
Results Overview
By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
518 participants
Primary outcome timeframe
6-12 months
Results posted on
2016-12-23
Participant Flow
978 persons inquired about the program. 847 took steps to qualify for an employer health insurance discount Of these, 294 declined to enroll, e.g. for being in the precontemplative stage of change. 553 persons participated in coaching. Of these, 35 worked with coaches in training. 518 participants enrolled in the randomized trial.
Participant milestones
| Measure |
Directive
Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.
Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.
|
Nondirective
Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.
Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call.
|
|---|---|---|
|
Overall Study
STARTED
|
258
|
260
|
|
Overall Study
COMPLETED
|
176
|
185
|
|
Overall Study
NOT COMPLETED
|
82
|
75
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Worksite Phone Counseling for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Directive
n=258 Participants
Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.
Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.
|
Nondirective
n=260 Participants
Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.
Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call.
|
Total
n=518 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
252 Participants
n=93 Participants
|
254 Participants
n=4 Participants
|
506 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 11.3 • n=93 Participants
|
46.0 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
46.2 years
STANDARD_DEVIATION 10.9 • n=27 Participants
|
|
Gender
Female
|
172 Participants
n=93 Participants
|
172 Participants
n=4 Participants
|
344 Participants
n=27 Participants
|
|
Gender
Male
|
86 Participants
n=93 Participants
|
88 Participants
n=4 Participants
|
174 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
250 Participants
n=93 Participants
|
252 Participants
n=4 Participants
|
502 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 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
|
50 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
199 Participants
n=93 Participants
|
199 Participants
n=4 Participants
|
398 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
258 participants
n=93 Participants
|
260 participants
n=4 Participants
|
518 participants
n=27 Participants
|
|
Income
|
3 units on a scale
n=93 Participants
|
3 units on a scale
n=4 Participants
|
3 units on a scale
n=27 Participants
|
|
Education
|
6 units on a scale
n=93 Participants
|
6 units on a scale
n=4 Participants
|
6 units on a scale
n=27 Participants
|
|
Fagerström Test for Nicotine Dependence (FTND)
|
3 units on a scale
n=93 Participants
|
3 units on a scale
n=4 Participants
|
3 units on a scale
n=27 Participants
|
PRIMARY outcome
Timeframe: 6-12 monthsPopulation: These are participants who were successfully contacted at 6 or 12 months following enrollment. Other participants are counted as continuing smokers.
By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment.
Outcome measures
| Measure |
Directive
n=176 Participants
Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.
Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.
|
Nondirective
n=185 Participants
Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.
Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call.
|
|---|---|---|
|
Smoking Abstinence for 7 Days at Last Contact
|
68 participants
|
77 participants
|
Adverse Events
Directive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nondirective
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. Walton Sumner
Washington University School of Medicine
Phone: 314-454-8164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place