SmokingPhase 1NCT00665704
Tobacco Tactics Website for Veteran Smokers
A Phase 1 study testing Tobacco Tactics website in people with Smoking, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Tobacco Tactics website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran,
- Screen Positive for Current Smoking,
- Greater than 18 Years of Age,
- Access to the Internet
Who cannot join
- Non-English Speaking,
- Have Unstable Physical or Psychiatric/Mental Conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Tobacco Tactics website
- Keywords
- Smoking Cessation, Internet, Intervention Studies, Health Services Accessibility
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco Tactics websiteBehavioural
Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers
| Study group | Role | What they receive |
|---|---|---|
| Tobacco Tactics Website | Experimental | Nine veteran smokers who will pilot test the Tobacco Tactics website Receives: Behavioral: Tobacco Tactics website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post intervention
Secondary outcomes (1)
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.
Measured: 30 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMar 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sonia A. Duffy, PhD MS RN, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665704
- Sponsor's protocol ID
- SHP 08-197
- Status last verified
- Jun 2014
- First submitted
- 22 Apr 2008
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23811612
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Tactics Website for Veteran Smokers
- ClinicalTrials.gov ID
- NCT00665704
- Acronym / sponsor ID
- SHP 08-197
- Conditions
- Smoking
- Keywords
- Smoking Cessation, Internet, Intervention Studies, Health Services Accessibility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Posted 23 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tobacco Tactics Website | Experimental | Behavioral: Tobacco Tactics websiteNine veteran smokers who will pilot test the Tobacco Tactics website |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran,
- Screen Positive for Current Smoking,
- Greater than 18 Years of Age,
- Access to the Internet
Key exclusion criteria (2 listed)
- Non-English Speaking,
- Have Unstable Physical or Psychiatric/Mental Conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco Tactics websitePilot test the Tobacco Tactics website tailored to the needs of veteran smokers | Behavioural | Tobacco Tactics Website |
Primary outcome
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.
1 secondary outcome
Patient Feedback to Evaluate the Website
Time frame: 30 days post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23811612Duffy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia A. Duffy, PhD MS RN principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tobacco Tactics website in people with Smoking, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Reported 30 Day Smoking Quit Rate (time frame: 30 days post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00665704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.