Clinical trial NCT00749151: Effectiveness of the American Lung Association Reactive Anti-Smoking Telephone Help Line in Illinois
Official title: A Randomized Controlled Trial on the Effectiveness of the American Lung Association Reactive Anti-Smoking Telephone Help Line in Illinois
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoking cessation
telephone help line
Lead sponsor: Southern Illinois University
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2008-09-09
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: point prevalence abstinence rate
timeFrame: not a single puff for 7 day minimum
measure: continuous abstinence rate
timeFrame: calculated at 1, 3, and 6 months
measure: change in behavioral stage with respect to smoking (transtheoretical model)
timeFrame: baseline, 1, 3, 6, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
Study officials:
affiliation: SIU School of Medicine
name: Akshay Sood, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: