Clinical trial NCT00222703: Enhancing Tobacco Abstinence Following Hospitalization
Official title: Enhancing Tobacco Abstinence Following Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalized Smokers
Chronic Diseases
Tobacco Use Disorder
Keywords: nicotine addiction
relapse
smoking
chronic disorders
randomized controlled trial
intervention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Eta Chapter, Sigma Theta Tau
name: Pauline Thompson Clinical Research Award, Nursing Foundation of Pennsylvania
First posted: 2005-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Self reported smoking status validated by exhaled CO
Secondary outcomes:
measure: Time to smoking lapse
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Donna D Caruthers, PHD
role: PRINCIPAL_INVESTIGATOR
References: