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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 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Enhancing Tobacco Abstinence Following Hospitalization |
Estimated Enrollment: | 80 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | March 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |||||
University of Pittsburgh | |||||
Pittsburgh, Pennsylvania, United States, 15261 |
University of Pittsburgh |
National Institute of Nursing Research (NINR) |
Eta Chapter, Sigma Theta Tau |
Pauline Thompson Clinical Research Award, Nursing Foundation of Pennsylvania |
Principal Investigator: | Donna D Caruthers, PHD | University of Pittsburgh |
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 |
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