Effectiveness of the American Lung Association Reactive Anti-Smoking Telephone Help Line in Illinois (QUITLINE)

A Randomized Controlled Trial on the Effectiveness of the American Lung Association Reactive Anti-Smoking Telephone Help Line in Illinois

An estimated 47 million adult Americans smoke. The American Lung Association has launched a reactive telephone help line to assist in smoking cessation. The proposed study will evaluate its effectiveness in a randomized controlled trial design involving active smokers who call this helpline. Eligible callers will be randomized into two groups: those who receive self-help literature only (i.e. control group) and those who receive additional reactive telephone counseling (i.e. study group). Detailed information will be collected proactively by an independent research calling specialist from all subjects who enroll into the study, by way of follow-up telephone calls, at one, three, six and twelve months following the screen date. The outcome measures to be compared are abstinence rates, quit attempts, changes in extent of smoking and behavioral stage, and cost-effectiveness. A thousand subjects will be enrolled in the two study arms in equal numbers over a period of fifteen months. Intent to treat analysis will be used after adjustment for covariates. The significance of this study lies in establishing the public health importance of such a reactive telephone helpline as a low intensity and low cost interventional smoking cessation tool.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: telephone counseling

Detailed Description

An estimated 47 million adult Americans smoke. Telephone counseling is considered a promising mode of intervention for smoking cessation. While pro-active (acting in anticipation of future change) telephone counseling has been shown to be efficacious in randomized trials, evaluation of reactive (occurring as a result of a stimulus) phone lines has been criticized by the lack of randomization and adequate controls for comparison. The American Lung Association has launched a reactive telephone help line to assist in smoking cessation. The proposed study will evaluate its effectiveness in a randomized controlled trial design involving active smokers who call this helpline. Eligible callers will be randomized into two groups: those who receive self-help literature only (i.e. control group) and those who receive additional reactive telephone counseling (i.e. study group). Detailed information will be collected proactively by an independent research calling specialist from all subjects who enroll into the study, by way of follow-up telephone calls, at one, three, six and twelve months following the screen date. The outcome measures to be compared are abstinence rates, quit attempts, changes in extent of smoking and behavioral stage, and cost-effectiveness. A thousand subjects will be enrolled in the two study arms in equal numbers over a period of fifteen months. Intent to treat analysis will be used after adjustment for covariates. The significance of this study lies in establishing the public health importance of such a reactive telephone helpline as a low intensity and low cost interventional smoking cessation tool.

• Study Type: Interventional
• Enrollment (Actual): 990
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Springfield, Illinois, United States, 62702
      • SIU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be an active nicotine user at the time of initial contact with the Tobacco
• Quitline, and interested in quitting nicotine
• Establish contact, by himself or herself, with the ALA, seeking help in quitting nicotine;
• Be contactable by telephone, and
• Be agreeable to consenting for the study and for follow-up by telephone interviews for a total period of six months

Exclusion Criteria:

• Pregnant subjects,
• Minors (under 18 years of age),
• People with current psychiatric conditions other than anxiety or depression,
• Refusal or inability to consent

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Literature
Experimental: Lit + Counseling	Behavioral: telephone counseling; First time callers to telephone help line agreed to one year follow-up on smoking cessation.; Other Names: American Lung Association Quit Line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
point prevalence abstinence rate	not a single puff for 7 day minimum
continuous abstinence rate	calculated at 1, 3, and 6 months
change in behavioral stage with respect to smoking (transtheoretical model)	baseline, 1, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Southern Illinois University
• Collaborators: American Lung Association
• Investigators: Principal Investigator: Akshay Sood, MD, MPH, SIU School of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: September 5, 2008
• First Submitted That Met QC Criteria: September 5, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Estimate): November 18, 2010
• Last Update Submitted That Met QC Criteria: November 17, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: smoking cessation; telephone help line
• Other Study ID Numbers: SIUSOM-08-004