Evaluation of a Computer-Delivered 5 A's Intervention for Smoking

Study Overview
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Brief Summary
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This is a 2-group RCT in 380 tobacco-using medical patients that will compare a single session, computer-directed 5 A's intervention for smoking (experimental condition) to screening and resource provision (control condition). Follow-up visits will occur at 1 and 3 months post study enrollment. Measures will focus on tobacco use and related psychosocial outcomes (e.g. mood, stress). We will compare resources used and economic costs needed to implement each intervention. The Investigators hypothesize that patients receiving the computer-directed intervention will have significantly higher tobacco abstinence rates at 3 months post study enrollment compared to the control group. If indeed the computerized intervention increases tobacco abstinence rates compared to the control group, this intervention could be used to increase access to treatment for the millions of US smokers, ultimately reducing tobacco mortality and morbidity rates in this country.

Official Title
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Evaluation of a Computer-Delivered 5 A's Intervention for Smoking

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Computer-directed 5 A's intervention for smoking
* Behavioral: Screening and resource provision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 65 years Primary care patient Smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week Smoked at least 100 cigarettes (lifetime) Had no recent (past 90 days) use of other forms of tobacco (pipes, cigars, NRT) Able to speak English Exclusion Criteria: - Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer-directed 5 A's intervention for smoking<br> | Behavioral: Computer-directed 5 A's intervention for smoking<br>* Computer-directed 5 A's intervention for smoking<br>|
| Active Comparator: Screening and resource provision<br> | Behavioral: Screening and resource provision<br>* Screening and resource provision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco use | The primary outcome variable for this study will be smoking cessation at 3 month follow-up as measured by self-report, salivary cotinine and carbon monoxide levels. | 3 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood and stress | By using the K-10 Instrument | 3 months post-randomization | 
| Resource utilization and economic costs |  | 3 months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco, smoking, smoking cessation