Tobacco Tactics Website for Veteran Smokers

Smoking Clinical Trial

Official title:

Tobacco Tactics Website for Veteran Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665704
• Other study ID #: SHP 08-197
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2008
• Last updated: April 6, 2015
• Start date: March 2009
• Est. completion date: March 2009

Study information

• Verified date: June 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop an evidence-based Tobacco Tactics website tailored to veterans based on an intervention tested in the VA.

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:

1. be available by phone to answer any questions;

2. collect qualitative data on veterans use of the Tobacco Tactics website; and,

3. note the 30 day quit rate.

Formative evaluation during pre-testing will include 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 try to use the Tobacco Tactics website to quit smoking, we will be 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.

Impact evaluation will be the 30 day quit rates of the 9 veteran smokers that agree to use the website.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Tobacco Tactics website
Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Duffy SA, Fowler KE, Flanagan PS, Ronis DL, Ewing LA, Waltje AH. The development of the tobacco tactics website. JMIR Res Protoc. 2013 Jun 28;2(2):e22. doi: 10.2196/resprot.2445. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Reported 30 Day Smoking Quit Rate	Impact evaluation was the 30-day quit rates of the 9 veteran smokers that agreed to use the website.	30 days post intervention	No
Secondary	Patient Feedback to Evaluate the Website	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	No