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Disease Management for Smokers in Rural Primary Care


Phase 3
18 Years
N/A
Not Enrolling
Both
Smoking Cessation

Thank you

Trial Information

Disease Management for Smokers in Rural Primary Care


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.


Inclusion Criteria:



- Over the age of 18

- Reported smoking at least 10 cigarettes per day for at least 25 of the last 30 days

- Speak English

- Their regular physician is a participating physician

- Working home telephone or cellular phone

Exclusion Criteria:

- Women who are pregnant or planning to become pregnant in the next two years

- Plan on moving within two years

- Display signs of dementia or other mental disorders

- Live with a smoker already enrolled

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

7-day point prevalence abstinence from cigarettes

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Edward F. Ellerbeck, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

5 R01 CA101963

NCT ID:

NCT00440115

Start Date:

June 2009

Completion Date:

December 2010

Related Keywords:

  • Smoking Cessation
  • Smoking

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353