NCT00440115

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

June 7, 2017

Completed
Last Updated

June 7, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

February 23, 2007

Results QC Date

March 23, 2017

Last Update Submit

May 8, 2017

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • 7-day Point Prevalence Abstinence From Cigarettes

    Self-reported 7-day point prevalence abstinence from cigarettes

    24 months

Secondary Outcomes (2)

  • Number of Quit Attempts

    6, 12, 18, 24 months

  • Progress in Stage of Change

    6, 12, 18, 24 months

Study Arms (3)

High intensity disease management

EXPERIMENTAL

High intensity disease management, free nicotine replacement therapy or bupropion

Behavioral: High intensity disease managementDrug: Bupropion

Low intensity disease management

EXPERIMENTAL

Low intensity disease management, free nicotine replacement therapy or bupropion

Behavioral: Low intensity disease managementDrug: Bupropion

Comparison group

OTHER

Comparison group, free nicotine replacement therapy or bupropion

Behavioral: Comparison groupDrug: Bupropion

Interventions

High intensity disease managementBEHAVIORAL

Health education mailings, 6 motivation interviews/counseling

High intensity disease management
Low intensity disease managementBEHAVIORAL

Health education mailings, one motivation interview/counseling

Low intensity disease management
Comparison groupBEHAVIORAL

Health education mailings

Comparison group
BupropionDRUG

Buproprion or Nicotine Replacement Therapy

Also known as: Nicotine Replacement Therapy
Comparison groupHigh intensity disease managementLow intensity disease management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (10)

  • 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.

    PMID: 21233256RESULT

  • 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.

    PMID: 19901150RESULT

  • 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.

    PMID: 19349629RESULT

  • 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.

    PMID: 18544464RESULT

  • 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.

    PMID: 18420774RESULT

  • 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.

    PMID: 18397444RESULT

  • 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.

    PMID: 18236294RESULT

  • 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.

    PMID: 18065851RESULT

  • 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.

    PMID: 16801293RESULT

  • 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.

    PMID: 22770436DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

BupropionNicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsDrug TherapyTherapeutics

Results Point of Contact

Title
Edward F. Ellerbeck, MD, MPH, Chair
Organization
Department of Preventive Medicine & Public Health
eellerbe@kumc.edu
913-588-2829

Study Officials

  • Edward F. Ellerbeck, MD, MPH

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 26, 2007

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 7, 2017

Results First Posted

June 7, 2017

Record last verified: 2017-05

Locations

US(1)