NCT00440115

Disease Management for Smoking Cessation

Disease Management for Smokers in Rural Primary Care

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for smoking. The hypotheses are to compare abstinence from cigarettes, the number of quit attempts, and smokers motivation at 24 months between participants receiving high and low intensity disease management and those receiving usual care.

Detailed description

The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for nicotine dependence. In this study, we will recruit 750 smokers from 20 rural, primary care clinics in Kansas. Subjects will be randomly assigned to one of three study arms, each providing 20 months of treatment: C (comparison group), LDM (low-intensity disease management) or HDM (high-intensity disease management). Participants in group C will receive health educational mailings and an offer for free nicotine replacement therapy (six weeks) or bupropion (seven weeks) every 6 months (months 0, 6, 12, and 18). Participants in LDM will receive the same interventions as C plus a low-intensity disease management program that includes a single telephone counseling session using motivational interviewing (MI) at months 0, 6, 12, and 18 to encourage a cessation attempt and also includes coordination of smoking assessments and pharmacotherapy with the patient's physician. HDM participants will receive C plus a high intensity disease management program that includes up to six telephone-based MI counseling sessions at months 0, 6, 12, and 18 to encourage a smoking cessation attempt and to prevent relapse after a quit attempt, as well as coordination of smoking assessments, quit attempts, and pharmacotherapy with the patient's physician. The primary outcome of the study is 7-day point prevalence abstinence from cigarettes at 2 years after enrollment. Secondary outcomes include: 1) number of quit attempts and 2) progress in stage of change. If successful, this intervention will provide a generalizable model for addressing nicotine dependence that could improve long-term management of smoking in primary care.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
BEHAVIORAL	High intensity disease management	Health education mailings, 6 motivation interviews/counseling
BEHAVIORAL	Low intensity disease management	Health education mailings, one motivation interview/counseling
BEHAVIORAL	Comparison group	Health education mailings
DRUG	Bupropion	Buproprion or Nicotine Replacement Therapy

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-02-26
• Last updated: 2017-06-07
• Results posted: 2017-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study