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Trial record 69 of 2035 for:    Smoking Cessation

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
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Social support is poorly understood but likely to influence outcomes of behavior change efforts. Social support may take a directive or nondirective approach. In directive support, the person attempting a behavior change is told what to do and even what to think. In nondirective support, the person attempting the behavior change decides what to discuss. In some contexts, interactions of race or income with social support have been reported. This is a randomized controlled trial of directive and nondirective coaching in the context of a smoking quitline offered to employees of two large corporations.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Nondirective smoking cessation coaching Behavioral: Directive smoking cessation coaching Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Experimental: Nondirective
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smoking employee or spouse in contemplation, action, or recently entering maintenance stage of change
  • English speaking

Exclusion Criteria:

  • Smoker in precontemplation stage of change

Information from the National Library of Medicine

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


Locations
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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Walton Sumner, MD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02730260     History of Changes
Other Study ID Numbers: 04-1335
First Posted: April 6, 2016    Key Record Dates
Results First Posted: December 23, 2016
Last Update Posted: December 23, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Researchers interested in using individual participant data may contact the PI. Only de-identified baseline, 6 month, and 12 month data will be available.

Keywords provided by Washington University School of Medicine:
Directive coaching
Nondirective coaching
smoking cessation quitline
social support