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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA101963 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity disease management | Experimental | High intensity disease management, free nicotine replacement therapy or bupropion |
|
| Low intensity disease management | Experimental | Low intensity disease management, free nicotine replacement therapy or bupropion |
|
| Comparison group | Other | Comparison group, free nicotine replacement therapy or bupropion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity disease management | Behavioral | Health education mailings, 6 motivation interviews/counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point Prevalence Abstinence From Cigarettes | Self-reported 7-day point prevalence abstinence from cigarettes | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Quit Attempts | Number of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period. | 6, 12, 18, 24 months |
| Progress in Stage of Change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward F. Ellerbeck, MD, MPH | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21233256 | Result | 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. | |
| 19901150 | Result | 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. |
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Smokers screened for eligibility (n=1827)
Ineligible (n=714)
Invited to participate (n=1113)
Declined to participate (n=305) Unable to contact (n=58)
Randomly assigned (n=750)
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| ID | Title | Description |
|---|---|---|
| FG000 | High-intensity Disease Management | Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions |
| FG001 | Moderate-intensity Disease Management | Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions |
| FG002 | Pharmacotherapy Management (Comparison Group) | Health education mailings, free nicotine replacement therapy or bupropion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-intensity Disease Management | Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions |
| BG001 | Moderate-intensity Disease Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-day Point Prevalence Abstinence From Cigarettes | Self-reported 7-day point prevalence abstinence from cigarettes | We used generalized linear models for the primary endpoint (self-reported abstinence at 24 months). Missing values were imputed as smokers, deaths and incarcerations were excluded from analysis. | Posted | Count of Participants | Participants | 24 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-intensity Disease Management | Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dystonia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward F. Ellerbeck, MD, MPH, Chair | Department of Preventive Medicine & Public Health | 913-588-2829 | eellerbe@kumc.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D004358 | Drug Therapy |
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| Low intensity disease management | Behavioral | Health education mailings, one motivation interview/counseling |
|
| Comparison group | Behavioral | Health education mailings |
|
| Bupropion | Drug | Buproprion or Nicotine Replacement Therapy |
|
|
Progress in Stages of Change at 6, 12, 18, and 24 months |
| 6, 12, 18, 24 months |
| 19349629 | Result | 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. |
| 18544464 | Result | 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. |
| 18420774 | Result | 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. |
| 18397444 | Result | 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. |
| 18236294 | Result | 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. |
| 18065851 | Result | 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. |
| 16801293 | Result | 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. |
| 22770436 | Derived | 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. |
Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
| BG002 | Pharmacotherapy Management (Comparison Group) | Health education mailings, free nicotine replacement therapy or bupropion |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Stage of change | Count of Participants | Participants |
|
| OG002 | Pharmacotherapy Management (Comparison Group) | Health education mailings, free nicotine replacement therapy or bupropion |
|
|
|
| Secondary | Number of Quit Attempts | Number of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period. | Posted | Number | quit attempts | 6, 12, 18, 24 months |
|
|
|
| Secondary | Progress in Stage of Change | Progress in Stages of Change at 6, 12, 18, and 24 months | Posted | Count of Participants | Participants | 6, 12, 18, 24 months |
|
|
|
| 7 |
| 251 |
| 15 |
| 251 |
| 63 |
| 251 |
| EG001 | Moderate-intensity Disease Management | Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions | 11 | 249 | 2 | 249 | 46 | 249 |
| EG002 | Pharmacotherapy Management (Comparison Group) | Health education mailings, free nicotine replacement therapy or bupropion | 6 | 250 | 2 | 250 | 19 | 250 |
| Arterial Surgery | Cardiac disorders | Non-systematic Assessment |
|
| Atrial fibriliation | Cardiac disorders | Non-systematic Assessment |
|
| Broken Neck | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Bronchitis/COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Collapsed lung | Injury, poisoning and procedural complications | Non-systematic Assessment | As a result of a rodeo injury |
|
| Congestive Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
| Depression and Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
|
| Kidney Failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Removal of Lung Mass | Surgical and medical procedures | Non-systematic Assessment |
|
| Smoke Inhalation | Injury, poisoning and procedural complications | Non-systematic Assessment | As a result of occupational hazard |
|
| Stroke | Nervous system disorders | Non-systematic Assessment |
|
| Ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Heart Surgery | Cardiac disorders | Non-systematic Assessment |
|
| Cold Sores | Product Issues | Non-systematic Assessment |
|
| Constipation | Product Issues | Non-systematic Assessment |
|
| Depression | Product Issues | Non-systematic Assessment |
|
| Dizziness/Light Headedness | Product Issues | Non-systematic Assessment |
|
| Elevated heart rate or blood pressure | Product Issues | Non-systematic Assessment |
|
| Flu | Infections and infestations | Non-systematic Assessment |
|
| Headache | Product Issues | Non-systematic Assessment |
|
| Blood Clot | Vascular disorders | Non-systematic Assessment |
|
| Bowel Falure | Gastrointestinal disorders | Non-systematic Assessment |
|
| Broken Bone | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment | As a result of a fall |
|
| Crohn's Disease Complication | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diabetes Complication | Endocrine disorders | Non-systematic Assessment |
|
| Eye Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Kidney Stones | Renal and urinary disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Shingles | Infections and infestations | Non-systematic Assessment |
|
| Stomach Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Strep Throat | Infections and infestations | Non-systematic Assessment |
|
| Scheduled Surgery/Medical Procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Irritability/Nervousness | Product Issues | Non-systematic Assessment |
|
| Nausea | Product Issues | Non-systematic Assessment |
|
| Nose Bleeds | Product Issues | Non-systematic Assessment |
|
| Shakiness | Product Issues | Non-systematic Assessment |
|
| Skin Irritation | Product Issues | Non-systematic Assessment |
|
| Sleep Disturbance | Product Issues | Non-systematic Assessment |
|
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| D013812 |
| Therapeutics |
|
| Month 6 : No Quit Attempt |
|
| Month 12 : Quit Attempted |
|
| Month 12 : Deceased/Incarcerated |
|
| Month 12 : No Quit Attempt |
|
| Month 18 : Quit Attempted |
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| Month 18 : Deceased/Incarcerated |
|
| Month 18 : No Quit Attempt |
|
| Month 24 : Quit Attempted |
|
| Month 24 : Deceased/Incarcerated |
|
| Month 24 : No Quit Attempt |
|
| Preparation |
|
| Quit (Action/Maintenance) |
|
| Unknown |
|
| Deceased/Incarcerated |
|
| Month 12 |
|
| Month 18 |
|
| Month 24 |
|