University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT00440115
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Kansas City, Kansas, 66160, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Health education mailings, 6 motivation interviews/counseling
Health education mailings, one motivation interview/counseling
Health education mailings
Buproprion or Nicotine Replacement Therapy
Other names: Nicotine Replacement Therapy
Time frame: 24 months
Self-reported 7-day point prevalence abstinence from cigarettes
Time frame: 6, 12, 18, 24 months
Number of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period.
Time frame: 6, 12, 18, 24 months
Progress in Stages of Change at 6, 12, 18, and 24 months
University of Kansas Medical Center
Other
Disease Management for Smokers in Rural Primary Care
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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