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

NCT ID: NCT00749151

Last Updated: 2010-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 990 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2007-03-31

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.

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.

Conditions

Smoking

Keywords

smoking cessation; telephone help line

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Literature

Group Type: NO_INTERVENTION

No interventions assigned to this group

Lit + Counseling

Group Type: EXPERIMENTAL

telephone counseling

Intervention Type: BEHAVIORAL

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

Interventions

telephone counseling

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

Intervention Type: BEHAVIORAL

Other Intervention Names

American Lung Association Quit Line

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Lung Association

OTHER

Sponsor Role: collaborator

Southern Illinois University

OTHER

Sponsor Role: lead

Responsible Party

SIU School of Medicine

Principal Investigators

Akshay Sood, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

SIU School of Medicine

Locations

SIU School of Medicine

Springfield, Illinois, United States

Countries

United States

Other Identifiers

SIUSOM-08-004

Identifier Type: -

Identifier Source: org_study_id