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

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.

Study Overview

• Status: Terminated
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Computer-directed 5 A's intervention for smoking; Behavioral: Screening and resource provision

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 24, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (Estimate): June 28, 2011

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: smoking; smoking cessation; tobacco
• Other Study ID Numbers: SBIRTCSVCU; R01DA026091 (U.S. NIH Grant/Contract)