- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00665704
Tobacco Tactics Website for Veteran Smokers
Study Overview
Detailed Description
Despite the detrimental effects of smoking, approximately 33% of veterans continue to smoke compared to approximately 21% of the general population. While efficacious cessation interventions are available, implementation of cessation interventions remains a challenge and new intervention strategies are needed to reach veterans. VA cessation providers recently met in Atlanta and one recommendation was to develop a cessation website for veterans. The evidence-based Tobacco Tactics website will be designed, pre-tested, and pilot tested as an intervention to assist veteran smokers to quit smoking. The efficacy of the website will then be tested in a subsequent randomized control trial (RCT). If the website proves efficacious, it would decrease morbidity and mortality among veterans, decrease face-to-face cessation intervention time for providers, and reach veterans in areas all over the country, perhaps through the VA "My Healthy Vet" website. This is a Phase 1 behavioral clinical trial designed to develop and pilot test a web-based Tobacco Tactics intervention tailored to veteran smokers. First, we will outline the specific content areas to be addressed. Second, we will develop the Tobacco Tactics intervention with our web designer in accordance with VA Web Operations. Third, a member of the research team will go through the website with the 5 veteran smokers obtaining feedback and noting any problems that occur. Fourth, with human studies approval, we will pilot test the impact of the intervention with 9 veteran smokers recruited to quit smoking using the Tobacco Tactics website. A research nurse will:
- be available by phone to answer any questions;
- collect qualitative data on veterans use of the Tobacco Tactics website; and,
- note the 30 day quit rate.
Formative evaluation during pre-testing will include qualitative feedback on the:
- ability to accomplish tasks;
- ability to accomplish goals with skill and speed;
- ability to operate the system; and
- satisfaction.
For the 9 veteran smokers that actually try to use the Tobacco Tactics website to quit smoking, we will be able to determine:
- the number of times they signed onto the website;
- the time spent on the website; and
- the number of times each module was accessed.
Impact evaluation will be the 30 day quit rates of the 9 veteran smokers that agree to use the website.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Michigan
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Ann Arbor, Michigan, United States, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Veteran,
- Screen Positive for Current Smoking,
- Greater than 18 Years of Age,
- Access to the Internet
Exclusion Criteria:
- Non-English Speaking,
- Have Unstable Physical or Psychiatric/Mental Conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tobacco Tactics Website
Nine veteran smokers who will pilot test the Tobacco Tactics website
|
Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self Reported 30 Day Smoking Quit Rate
Time Frame: 30 days post intervention
|
Impact evaluation was the 30-day quit rates of the 9 veteran smokers that agreed to use the website.
|
30 days post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Feedback to Evaluate the Website
Time Frame: 30 days post intervention
|
Formative evaluation during pre-testing included qualitative feedback on the: 1) ability to accomplish tasks; 2) ability to accomplish goals with skill and speed; 3) ability to operate the system; and 4) satisfaction.
For the 9 veteran smokers that actually tried to use the Tobacco Tactics website to quit smoking, we were able to determine: 1) the number of times they signed onto the website; 2) the time spent on the website; and 3) the number of times each module was accessed.
|
30 days post intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sonia A. Duffy, PhD MS RN, VA Ann Arbor Healthcare System, Ann Arbor, MI
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SHP 08-197
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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