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

Smoking Clinical Trial

— QUITLINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749151
• Other study ID #: SIUSOM-08-004
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: November 17, 2010
• Start date: December 2002
• Est. completion date: March 2007

Study information

• Verified date: November 2010
• Source: Southern Illinois University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 990
• Est. completion date: March 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Smoking

Intervention

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

Locations

Country	Name	City	State
United States	SIU School of Medicine	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Southern Illinois University	American Lung Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	point prevalence abstinence rate		not a single puff for 7 day minimum	No
Primary	continuous abstinence rate		calculated at 1, 3, and 6 months	No
Primary	change in behavioral stage with respect to smoking (transtheoretical model)		baseline, 1, 3, 6, and 12 months	No