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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00394420
Other study ID # 1321-03
Secondary ID
Status Completed
Phase N/A
First received October 31, 2006
Last updated January 19, 2010
Start date September 2003
Est. completion date April 2006

Study information

Verified date January 2010
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 2006
Est. primary completion date April 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- We enrolled patients aged 18 or older who reported current daily cigarette smoking for at least one year and who indicated an interest in attempting to quit smoking.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Telephone Quitline


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome was completion of the QL intervention.
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