Expired Study
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Ann Arbor, Michigan 48105


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

SHP 08-197


NCT ID:

NCT00665704


Secondary ID:


Study Acronym:


Brief Title:

Tobacco Tactics Website for Veteran Smokers


Official Title:

Tobacco Tactics Website for Veteran Smokers


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

9


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sonia A. Duffy, PhD MS RN
Principal Investigator
VA Ann Arbor Healthcare System

Study Dates

Start Date:March 2009
Completion Date:March 2009
Completion Type:Actual
Primary Completion Date:March 2009
Primary Completion Type:Actual
Verification Date:August 2014
Last Changed Date:August 5, 2014
First Received Date:April 22, 2008
First Results Date:June 25, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Patient Feedback to Evaluate the Website
Time Frame:30 days post intervention
Safety Issues:False
Description: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 actua
Outcome Type:Primary Outcome
Measure:Self Reported 30 Day Smoking Quit Rate
Time Frame:30 days post intervention
Safety Issues:False
Description:Impact evaluation was the 30-day quit rates of the 9 veteran smokers that agreed to use the website.

Study Interventions

Intervention Type:Behavioral
Name:Tobacco Tactics Website
Description:Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers
Arm Name:Tobacco Tactics Website

Study Arms

Study Arm Type:Experimental
Arm Name:Tobacco Tactics Website
Description:Nine veteran smokers who will pilot test the Tobacco Tactics website

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:23811612

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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