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Enhancing Tobacco Abstinence Following Hospitalization

This study has been completed.

Sponsors and Collaborators: University of Pittsburgh
National Institute of Nursing Research (NINR)
Eta Chapter, Sigma Theta Tau
Pauline Thompson Clinical Research Award, Nursing Foundation of Pennsylvania
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00222703
  Purpose

The primary aim of this study is to examine the efficacy of a 12-week nurse-delivered relapse management intervention designed with conceptual underpinnings from Self-efficacy Theory to enhance smoking abstinence of hospitalized smokers following their hospital discharge. Specifically this study asks, does a 12-week Self-efficacy Theory driven relapse management intervention enhance smoking abstinence following hospitalization by increasing smoking abstinence point prevalence as measured by carbon monoxide validated self-reports of smoking, when compared to subjects receiving only enhanced usual care?


Condition Intervention
Hospitalized Smokers
Chronic Diseases
Tobacco Use Disorder
Behavioral: Smoking relapse prevention

MedlinePlus related topics:   Coping with Chronic Illness    Smoking   

ChemIDplus related topics:   Nicotine polacrilex    Nicotine tartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Enhancing Tobacco Abstinence Following Hospitalization

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Self reported smoking status validated by exhaled CO

Secondary Outcome Measures:
  • Time to smoking lapse

Estimated Enrollment:   80
Study Start Date:   May 2002
Estimated Study Completion Date:   March 2005

Detailed Description:

A randomized controlled two-group design with an intent-to-treat approach for handling protocol deviations will be used to examine the primary aim of this project. The sample will consist of 80 consenting smokers prospectively recruited during hospitalization. Subjects will be randomly assigned by equal allocation to an intervention group or an enhanced usual only group. A baseline adaptive randomization procedure will adjust the random equal ratio of treatment assignment to maintain sampling balance of the groups for race (White/Black/Other), gender (male/female), and three comorbid categories (only tobacco related illnesses/ tobacco related and unrelated to tobacco illnesses/ unrelated to tobacco illnesses). All subjects will receive enhanced usual care, which will consist of receiving a supportive message to quit smoking and smoking cessation materials. Subjects assigned to the intervention group will receive 9 intervention sessions with a nurse aimed to enhance their self-efficacy in self-management of tobacco abstinence. These sessions will occur over 12 weeks following hospital discharge. All but the initial session will occur by telephone. Subjects will be asked to participate with follow-up activities 12 weeks and 24 weeks following their hospital discharge, which requires the measurement of exhaled carbon monoxide and the completion of questionnaires by self-administration and interview with study personnel. Subjects will exit from study following the 24-week follow-up.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • smoked one cigarette within 30 days of hospital admission
  • admission to a medical/surgical patient care unit
  • 18 years of age or older

Exclusion Criteria:

  • diagnosis of cancer in a terminal state,
  • under evaluation for organ transplantation or awaiting transplantation,
  • cerebral vascular disorders,
  • senile dementia,
  • Alzheimer’s disease,
  • abstinence from smoking greater than one month,
  • non-English speaking,
  • lack of a home telephone,
  • lack of a mailing address,
  • lack of any ability to participate with self-care activities,
  • and transfer to a rehabilitation hospital or nursing home following their hospital admission.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222703

Locations
United States, Pennsylvania
University of Pittsburgh    
      Pittsburgh, Pennsylvania, United States, 15261

Sponsors and Collaborators
University of Pittsburgh
National Institute of Nursing Research (NINR)
Eta Chapter, Sigma Theta Tau
Pauline Thompson Clinical Research Award, Nursing Foundation of Pennsylvania

Investigators
Principal Investigator:     Donna D Caruthers, PHD     University of Pittsburgh    
  More Information


Study ID Numbers:   1 F31 NR07343
First Received:   September 14, 2005
Last Updated:   September 14, 2005
ClinicalTrials.gov Identifier:   NCT00222703
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
nicotine addiction  
relapse  
smoking  
chronic disorders
randomized controlled trial
intervention

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Behavior, Addictive
Nicotine
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin
Chronic Disease

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 03, 2008




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