Disease Management for Smoking Cessation

NCT ID: NCT00440115

Last Updated: 2017-06-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High intensity disease management

High intensity disease management, free nicotine replacement therapy or bupropion

Group Type EXPERIMENTAL

High intensity disease management

Intervention Type BEHAVIORAL

Health education mailings, 6 motivation interviews/counseling

Bupropion

Intervention Type DRUG

Buproprion or Nicotine Replacement Therapy

Low intensity disease management

Low intensity disease management, free nicotine replacement therapy or bupropion

Group Type EXPERIMENTAL

Low intensity disease management

Intervention Type BEHAVIORAL

Health education mailings, one motivation interview/counseling

Bupropion

Intervention Type DRUG

Buproprion or Nicotine Replacement Therapy

Comparison group

Comparison group, free nicotine replacement therapy or bupropion

Group Type OTHER

Comparison group

Intervention Type BEHAVIORAL

Health education mailings

Bupropion

Intervention Type DRUG

Buproprion or Nicotine Replacement Therapy

Interventions

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High intensity disease management

Health education mailings, 6 motivation interviews/counseling

Intervention Type BEHAVIORAL

Low intensity disease management

Health education mailings, one motivation interview/counseling

Intervention Type BEHAVIORAL

Comparison group

Health education mailings

Intervention Type BEHAVIORAL

Bupropion

Buproprion or Nicotine Replacement Therapy

Intervention Type DRUG

Other Intervention Names

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Nicotine Replacement Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward F. Ellerbeck, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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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. Epub 2011 Jan 13.

Reference Type RESULT
PMID: 21233256 (View on PubMed)

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.

Reference Type RESULT
PMID: 19901150 (View on PubMed)

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. doi: 10.7326/0003-4819-150-7-200904070-00003.

Reference Type RESULT
PMID: 19349629 (View on PubMed)

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: 10.1016/j.ypmed.2008.04.013. Epub 2008 May 3.

Reference Type RESULT
PMID: 18544464 (View on PubMed)

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.

Reference Type RESULT
PMID: 18420774 (View on PubMed)

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.

Reference Type RESULT
PMID: 18397444 (View on PubMed)

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.

Reference Type RESULT
PMID: 18236294 (View on PubMed)

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. doi: 10.1353/hpu.2007.0117.

Reference Type RESULT
PMID: 18065851 (View on PubMed)

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. doi: 10.1080/14622200600670132.

Reference Type RESULT
PMID: 16801293 (View on PubMed)

Yeh HW, Ellerbeck EF, Mahnken JD. Simultaneous evaluation of abstinence and relapse using a Markov chain model in smokers enrolled in a two-year randomized trial. BMC Med Res Methodol. 2012 Jul 7;12:95. doi: 10.1186/1471-2288-12-95.

Reference Type DERIVED
PMID: 22770436 (View on PubMed)

Other Identifiers

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5R01CA101963

Identifier Type: NIH

Identifier Source: secondary_id

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5R01CA101963

Identifier Type: NIH

Identifier Source: org_study_id

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