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Completed

NCT Number: NCT00749151

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SIU School of Medicine

Springfield, Illinois, 62702, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone counseling

Behavioral

First time callers to telephone help line agreed to one year follow-up on smoking cessation.

Other names: American Lung Association Quit Line

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Southern Illinois University

Other

Collaborators

  • American Lung Association

Registry information

Official study title

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

Acronym: QUITLINE

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Sep 9, 2008
Registry last updated
Nov 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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