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Enhancing Tobacco Abstinence Following Hospitalization

Primary Purpose

Hospitalized Smokers, Chronic Diseases, Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking relapse prevention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hospitalized Smokers focused on measuring nicotine addiction, relapse, smoking, chronic disorders, randomized controlled trial, intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh

Outcomes

Primary Outcome Measures

Self reported smoking status validated by exhaled CO

Secondary Outcome Measures

Time to smoking lapse

Full Information

First Posted
September 14, 2005
Last Updated
September 14, 2005
Sponsor
University of Pittsburgh
Collaborators
National Institute of Nursing Research (NINR), Eta Chapter, Sigma Theta Tau, Pauline Thompson Clinical Research Award, Nursing Foundation of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00222703
Brief Title
Enhancing Tobacco Abstinence Following Hospitalization
Official Title
Enhancing Tobacco Abstinence Following Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospitalized Smokers, Chronic Diseases, Tobacco Use Disorder
Keywords
nicotine addiction, relapse, smoking, chronic disorders, randomized controlled trial, intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Smoking relapse prevention
Primary Outcome Measure Information:
Title
Self reported smoking status validated by exhaled CO
Secondary Outcome Measure Information:
Title
Time to smoking lapse

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna D Caruthers, PHD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Enhancing Tobacco Abstinence Following Hospitalization

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