Disease Management for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Disease Management for Smokers in Rural Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440115
• Other study ID #: 5R01CA101963
• Secondary ID: 5R01CA101963
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2007
• Last updated: November 23, 2016
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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:
• High intensity disease management
Health education mailings, free nicotine replacement therapy or bupropion, 6 motivation interviews/counselling
• Low intensity disease management
Health education mailings, free nicotine replacement therapy or bupropion, one motivation interview/counselling

Other:
• Comparison group
Health education mailings, free nicotine replacement therapy or bupropion

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas Medical Center	GlaxoSmithKline, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (9)

Berg CJ, Cox LS, Nazir N, Mussulman LM, Ahluwalia JS, Ellerbeck EF. Correlates of home smoking restrictions among rural smokers. Nicotine Tob Res. 2006 Jun;8(3):353-60. — View Citation

Berg CJ, Sanderson Cox L, Mahnken JD, Greiner KA, Ellerbeck EF. Correlates of self-efficacy among rural smokers. J Health Psychol. 2008 Apr;13(3):416-21. doi: 10.1177/1359105307088144. — View Citation

Cox LS, Cupertino AP, Mussulman LM, Nazir N, Greiner KA, Mahnken JD, Ahluwalia JS, Ellerbeck EF. Design and baseline characteristics from the KAN-QUIT disease management intervention for rural smokers in primary care. Prev Med. 2008 Aug;47(2):200-5. doi: — View Citation

Cox LS, Wick JA, Nazir N, Cupertino AP, Mussulman LM, Ahluwalia JS, Ellerbeck EF. Predictors of early versus late smoking abstinence within a 24-month disease management program. Nicotine Tob Res. 2011 Mar;13(3):215-20. doi: 10.1093/ntr/ntq227. — View Citation

Cupertino AP, Mahnken JD, Richter K, Cox LS, Casey G, Resnicow K, Ellerbeck EF. Long-term engagement in smoking cessation counseling among rural smokers. J Health Care Poor Underserved. 2007 Nov;18(4 Suppl):39-51. — View Citation

Cupertino AP, Wick JA, Richter KP, Mussulman L, Nazir N, Ellerbeck EF. The impact of repeated cycles of pharmacotherapy on smoking cessation: a longitudinal cohort study. Arch Intern Med. 2009 Nov 9;169(20):1928-30. doi: 10.1001/archinternmed.2009.355. — View Citation

Cupertino PA, Richter KP, Cox LS, Nazir N, Greiner AK, Ahluwalia JS, Ellerbeck EF. Smoking cessation pharmacotherapy preferences in rural primary care. Nicotine Tob Res. 2008 Feb;10(2):301-7. doi: 10.1080/14622200701825817. — View Citation

Ellerbeck EF, Mahnken JD, Cupertino AP, Cox LS, Greiner KA, Mussulman LM, Nazir N, Shireman TI, Resnicow K, Ahluwalia JS. Effect of varying levels of disease management on smoking cessation: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):437-46. — View Citation

Hutcheson TD, Greiner KA, Ellerbeck EF, Jeffries SK, Mussulman LM, Casey GN. Understanding smoking cessation in rural communities. J Rural Health. 2008 Spring;24(2):116-24. doi: 10.1111/j.1748-0361.2008.00147.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence abstinence from cigarettes		24 months	No
Secondary	Number of quit attempts		6, 12 18 and 24 months	No
Secondary	Progress in stage of change		6, 12, 18 and 24 months	No