Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222703
Status:
COMPLETED
Last Update Posted:
2005-09-22
First Post:
2005-09-14
Brief Title:
Enhancing Tobacco Abstinence Following Hospitalization
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Enhancing Tobacco Abstinence Following Hospitalization
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 WhiteBlackOther gender malefemale 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None