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

NCT00749151 | Completed DMC

• 1 other identifier: SIUSOM-08-004
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

smoking cessation; telephone help line

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Literature

NO INTERVENTION

Lit + Counseling

EXPERIMENTAL

Behavioral: telephone counseling

Interventions

telephone counseling BEHAVIORAL

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

Also known as: American Lung Association Quit Line

Lit + Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Southern Illinois University: lead
• American Lung Association: collaborator

Study Sites (1)

SIU School of Medicine

Springfield, Illinois, 62702, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Akshay Sood, MD, MPH

  SIU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 9, 2008
• Study Start: December 1, 2002
• Primary Completion: February 1, 2007
• Study Completion: March 1, 2007
• Last Updated: November 18, 2010

Record last verified: 2010-11

Locations

US (1)