Study Stopped
Insufficient sample size to complete study and merged with parent grant funded study
Evaluation of a Computer-Delivered 5 A's Intervention for Smoking
2 other identifiers
interventional
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2011
CompletedFirst Posted
Study publicly available on registry
June 28, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 21, 2015
December 1, 2015
7 months
June 24, 2011
December 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Mood and stress
3 months post-randomization
Resource utilization and economic costs
3 months post-randomization
Study Arms (2)
Computer-directed 5 A's intervention for smoking
EXPERIMENTALScreening and resource provision
ACTIVE COMPARATORInterventions
Computer-directed 5 A's intervention for smoking
Screening and resource provision
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dace Svikis, PhD
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2011
First Posted
June 28, 2011
Study Start
February 1, 2012
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
December 21, 2015
Record last verified: 2015-12