Enhancing Tobacco Abstinence Following Hospitalization

NCT ID: NCT00222703

Last Updated: 2005-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2005-03-31

Brief 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?

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.

Conditions

Hospitalized Smokers; Chronic Diseases; Tobacco Use Disorder

Keywords

nicotine addiction; relapse; smoking; chronic disorders; randomized controlled trial; intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Smoking relapse prevention

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Eta Chapter, Sigma Theta Tau

OTHER

Sponsor Role: collaborator

Pauline Thompson Clinical Research Award, Nursing Foundation of Pennsylvania

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Principal Investigators

Donna D Caruthers, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

1F31NR007343

Identifier Type: NIH

Identifier Source: org_study_id

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