Enhancing Tobacco Abstinence Following Hospitalization

Status Completed

Clinical Trial Summary

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?

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00222703
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Completed
Phase	N/A
Start date	May 2002
Completion date	March 2005

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.