Worksite Phone Counseling for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Worksite Phone Counseling for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730260
• Other study ID #: 04-1335
• Status: Completed
• Phase: N/A
• First received: March 31, 2016
• Last updated: March 31, 2016
• Start date: February 2005
• Est. completion date: September 2008

Study information

• Verified date: March 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 847
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Nondirective smoking cessation coaching
Quitline coach allows participant to set agenda for each call.
• Directive smoking cessation coaching
Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence for 7 days at last contact	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.	6-12 months	No