Enhancing Tobacco Abstinence Following Hospitalization

Tobacco Use Disorder Clinical Trial

Official title:

Enhancing Tobacco Abstinence Following Hospitalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222703
• Other study ID #: 1F31NR007343
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: September 14, 2005
• Start date: May 2002
• Est. completion date: March 2005

Study information

• Verified date: September 2005
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases
• Hospitalized Smokers
• Tobacco Use Disorder

Intervention

Behavioral:
• Smoking relapse prevention

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	Eta Chapter, Sigma Theta Tau, National Institute of Nursing Research (NINR), Pauline Thompson Clinical Research Award, Nursing Foundation of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported smoking status validated by exhaled CO
Secondary	Time to smoking lapse