Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 69 of 2035 for:    Smoking Cessation

Worksite Phone Counseling for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02730260
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : December 23, 2016
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Smoking Cessation
Interventions Behavioral: Nondirective smoking cessation coaching
Behavioral: Directive smoking cessation coaching
Enrollment 518
Recruitment Details  
Pre-assignment Details

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.

Arm/Group Title Directive Nondirective
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 258 260
Completed 176 185
Not Completed 82 75
Arm/Group Title Directive Nondirective Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 258 260 518
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 260 participants 518 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
252
  97.7%
254
  97.7%
506
  97.7%
>=65 years
6
   2.3%
6
   2.3%
12
   2.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 258 participants 260 participants 518 participants
46.3  (11.3) 46.0  (10.6) 46.2  (10.9)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 260 participants 518 participants
Female
172
  66.7%
172
  66.2%
344
  66.4%
Male
86
  33.3%
88
  33.8%
174
  33.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 260 participants 518 participants
Hispanic or Latino
3
   1.2%
2
   0.8%
5
   1.0%
Not Hispanic or Latino
250
  96.9%
252
  96.9%
502
  96.9%
Unknown or Not Reported
5
   1.9%
6
   2.3%
11
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 260 participants 518 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.4%
1
   0.4%
2
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
50
  19.4%
51
  19.6%
101
  19.5%
White
199
  77.1%
199
  76.5%
398
  76.8%
More than one race
3
   1.2%
3
   1.2%
6
   1.2%
Unknown or Not Reported
5
   1.9%
6
   2.3%
11
   2.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 258 participants 260 participants 518 participants
258 260 518
Income   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 258 participants 260 participants 518 participants
3
(2 to 4)
3
(2 to 4)
3
(2 to 4)
[1]
Measure Description:

Income levels are:

  1. $0-$15,000
  2. >$15,000-$30,000
  3. >$30,000-$45,000
  4. >$45,000-$60,000
  5. >$60,000-$75,000
  6. >$75,000-$90,000
  7. >$90,000
Education   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 258 participants 260 participants 518 participants
6
(5 to 7)
6
(5 to 7)
6
(5 to 7)
[1]
Measure Description:

The education scale is:

  1. Less than 9th grade
  2. 9th grade
  3. 10th grade
  4. 11th grade
  5. High school graduate or General Educational Development (GED)
  6. Some college or trade school
  7. Bachelor's degree
  8. Master's degree
  9. Doctoral degree
Fagerström Test for Nicotine Dependence (FTND)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 258 participants 260 participants 518 participants
3
(1 to 5)
3
(1 to 4)
3
(1 to 4)
[1]
Measure Description:

Scores for 3 binary and 3 multiple choice items in the Fagerstrom Test for Nicotine Dependence are summed to yield a total score of 0-10.

.

Classification of dependence:

0-2 Very low; 3-4 Low; 5 Moderate; 6-7 High; 8-10 Very high.

1.Primary Outcome
Title Smoking Abstinence for 7 Days at Last Contact
Hide Description 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.
Time Frame 6-12 months
Hide Outcome Measure Data
Hide Analysis Population Description
These are participants who were successfully contacted at 6 or 12 months following enrollment. Other participants are counted as continuing smokers.
Arm/Group Title Directive Nondirective
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 176 185
Measure Type: Number
Unit of Measure: participants
68 77
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Directive, Nondirective
Comments Test of the null hypothesis that directive and nondirective coaching have equal smoking cessation rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Directive, Nondirective
Comments Odds ratio based on the parameter estimate for the variable, IncomeAboveMedian (0=false, 1=true), from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. An unbalanced variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.03
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Directive, Nondirective
Comments Odds ratio for PriorQuit, from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. This variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model because it was not balanced after randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.03
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.6
Estimation Comments [Not Specified]
Time Frame 2 years, 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Directive Nondirective
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Directive Nondirective
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Directive Nondirective
Affected / at Risk (%) Affected / at Risk (%)
Total   0/258 (0.00%)   0/260 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Directive Nondirective
Affected / at Risk (%) Affected / at Risk (%)
Total   0/258 (0.00%)   0/260 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Walton Sumner
Organization: Washington University School of Medicine
Phone: 314-454-8164
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02730260     History of Changes
Other Study ID Numbers: 04-1335
First Submitted: March 31, 2016
First Posted: April 6, 2016
Results First Submitted: June 1, 2016
Results First Posted: December 23, 2016
Last Update Posted: December 23, 2016