Viewing Study NCT00394420


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Study NCT ID: NCT00394420
Status: COMPLETED
Last Update Posted: 2010-01-20
First Post: 2006-10-31
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Emergency Department Telephone Quitline
Sponsor: Mayo Clinic
Organization:

Study Overview

Official Title: A Telephone Quitline Intervention for Smoking Cessation Through the Emergency Department
Status: COMPLETED
Status Verified Date: 2010-01
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 purpose of this preliminary study was to evaluate the intervention completion rate among cigarette smokers enrolled through the Emergency Department (ED) in a tobacco quitline (QL) and to assess the feasibility of a randomized controlled trial assessing the efficacy of this intervention.
Detailed Description: This pilot study was a prospective, randomized, controlled, un-blinded study using a convenience sample of cigarettes smokers recruited through the ED.

Utilizing a computerized block randomization schedule, subjects were randomized in blocks of four to receive a proactive QL intervention through an established QL or a United States Public Health Service (USPHS) self-help manual. Proactive telephone counseling describes counseling that is initiated by a counselor rather than the subject. Both groups received strong advice to quit from study personnel.

Names and telephone numbers of patients randomized to the QL group were faxed to the QL which then initiated contact with the patient. Multiple contact attempts were made over the following week by telephone. Patients in the QL were instructed to call the QL if they had not been reached in one week. QL counseling involved an initial 45-minute telephone session followed by up to four 10 to 15 minute follow-up sessions around their identified quit date. QL patients not successfully contacted within one week of enrollment were sent a letter inviting them to call as well as information on strategies to help them quit.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: