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

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ClinicalTrials.gov Identifier: NCT00749151
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : November 18, 2010
Sponsor:
Collaborator:
American Lung Association
Information provided by:
Southern Illinois University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: telephone counseling Not Applicable

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  (Clinical Trial)
Actual Enrollment : 990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: A Randomized Controlled Trial on the Effectiveness of the American Lung Association Reactive Anti-Smoking Telephone Help Line in Illinois
Study Start Date : December 2002
Actual Primary Completion Date : February 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

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 Name: American Lung Association Quit Line



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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749151


Locations
United States, Illinois
SIU School of Medicine
Springfield, Illinois, United States, 62702
Sponsors and Collaborators
Southern Illinois University
American Lung Association
Investigators
Principal Investigator: Akshay Sood, MD, MPH SIU School of Medicine

Responsible Party: Akshay Sood, M.D., M.P.H., SIU School of Medicine
ClinicalTrials.gov Identifier: NCT00749151     History of Changes
Other Study ID Numbers: SIUSOM-08-004
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: November 18, 2010
Last Verified: November 2010

Keywords provided by Southern Illinois University:
smoking cessation
telephone help line