Effectiveness of the American Lung Association Reactive Anti-Smoking Telephone Help Line in Illinois (QUITLINE)
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Purpose
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 | Intervention |
|---|---|
|
Smoking |
Behavioral: telephone counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | A Randomized Controlled Trial on the Effectiveness of the American Lung Association Reactive Anti-Smoking Telephone Help Line in Illinois |
- point prevalence abstinence rate [ Time Frame: not a single puff for 7 day minimum ] [ Designated as safety issue: No ]
- continuous abstinence rate [ Time Frame: calculated at 1, 3, and 6 months ] [ Designated as safety issue: No ]
- change in behavioral stage with respect to smoking (transtheoretical model) [ Time Frame: baseline, 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 990 |
| Study Start Date: | December 2002 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Illinois | |
| SIU School of Medicine | |
| Springfield, Illinois, United States, 62702 | |
| Principal Investigator: | Akshay Sood, MD, MPH | SIU School of Medicine |
More Information
No publications provided
| 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 |
| Study First Received: | September 5, 2008 |
| Last Updated: | November 17, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Southern Illinois University:
|
smoking cessation telephone help line |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 16, 2013