Worksite Phone Counseling for Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT02730260|
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : December 23, 2016
Last Update Posted : December 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Nondirective smoking cessation coaching Behavioral: Directive smoking cessation coaching||Not Applicable|
BACKGROUND Given the association of smoking with low socioeconomic status, the potential of telephone counseling for smoking cessation to reach diverse audiences needs evaluation. In addition, different approaches to counseling have not been systematically examined, and may differentially affect reach, retention, and success.
PURPOSE To describe employee participation and outcomes in a trial of two counseling styles for telephone-based smoking cessation support.
APPROACH Employees and spouses of two large organizations are invited to participate in a trial of a telephone quitline. Participants are randomized to one of two coaching styles. A protocol-driven (Directive) coaching approach follows a script for each of seven calls over 9 weeks. A participant-centered (Nondirective) coaching approach allowed smokers to select topics of interest, with prompting by the coach as needed. A computer assisted telephone interview program and database provide topics in correct sequence for directive coaching, allow coaches to indicate topics during nondirective coaching, and track time spent on topics in both conditions.
PREDICTOR VARIABLES Demographics, smoking history and conventional self-reported measures of nicotine dependence, smoking urges, preference for patient-centric care, and depression are collected at baseline.
OUTCOMES The primary outcome measure is self-reported abstinence from smoking for 7 days at the time of last follow up, 6 or 12 months after baseline assessment.
ANALYSES Interactions of Race and Income with coaching approach are analyzed. Based on results with asthma patients, a positive interaction of low income with nondirective coaching is tested.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||518 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Worksite Phone Counseling for Smoking Cessation|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Active Comparator: Directive
Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.
Behavioral: 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.
Behavioral: Nondirective smoking cessation coaching
Quitline coach allows participant to set agenda for each call.
- Smoking Abstinence for 7 Days at Last Contact [ Time Frame: 6-12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730260
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Walton Sumner, MD||Washington University School of Medicine|