Disease Management for Smoking Cessation

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00440115
First received: February 23, 2007
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Behavioral: High intensity disease management
Behavioral: Low intensity disease management
Other: Comparison group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Disease Management for Smokers in Rural Primary Care

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 7-day point prevalence abstinence from cigarettes [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of quit attempts [ Time Frame: 6, 12 18 and 24 months ] [ Designated as safety issue: No ]
  • Progress in stage of change [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 750
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
High intensity disease management
Behavioral: High intensity disease management
Health education mailings, free nicotine replacement therapy or bupropion, 6 motivation interviews/counselling
Experimental: 2
Low intensity disease management
Behavioral: Low intensity disease management
Health education mailings, free nicotine replacement therapy or bupropion, one motivation interview/counselling
3
Comparison group
Other: Comparison group
Health education mailings, free nicotine replacement therapy or bupropion

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440115

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
GlaxoSmithKline
Investigators
Principal Investigator: Edward F. Ellerbeck, MD, MPH University of Kansas
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00440115     History of Changes
Other Study ID Numbers: 5 R01 CA101963, 5R01CA101963
Study First Received: February 23, 2007
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014