SmokingPhase 2NCT01065493
QuitAdvisorMD: A Point-of-care Tool for Brief Smoking Cessation Interventions
A Phase 2 study testing QuitAdvisorMD Software Algorithm and Standard Smoking Cessation Counseling in people with Smoking and Tobacco Use Disorder, run by Silverchair Science & Communications, LLC at 1 site in United States.
Trial summary
QuitAdvisorMD: A point-of-care tool for brief smoking cessation interventions Under a Phase II SBIR grant supported by NIH/NIDA, we are developing QUITAdvisorMD: a point-of-care, patient-centered resource for counseling patients who smoke or use tobacco products. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Use Disorder
- What is being tested?
- QuitAdvisorMD Software Algorithm and Standard Smoking Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- any physician providing care for members of Southern Health through primary care and have access to a point-of-care computing device (Smartphone, desktop PC, etc) during patient visits.
Who cannot join
- Lack of appropriate computing device
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
QuitAdvisorMD: A point-of-care tool for brief smoking cessation interventions Under a Phase II SBIR grant supported by NIH/NIDA, we are developing QUITAdvisorMD: a point-of-care, patient-centered resource for counseling patients who smoke or use tobacco products. It is based on the principles of Motivational Interviewing, a non-confrontational and very effective method for intervening and treating these patients; the 5 A's of behavioral interventions; and the Transtheoretical Model of Change. Through a point and click interface, the tool uses a series of interview questions designed to motivate patients to stop smoking by first assessing their stage of change and then offering effective stage-based interventions and interview techniques. The tool also offers stage-tailored patient information, a clinician educational reference, and the ability to communicate support information patients via email and/or text message.
- Conditions
- Smoking, Tobacco Use Disorder
- Being tested
- QuitAdvisorMD Software Algorithm, Standard Smoking Cessation Counseling
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuitAdvisorMD Software AlgorithmOther
QuitAdvisorMD, a set of brief clinical assessments, counseling scripts and intervention instruments for smoking cessation in primary care settings
Standard Smoking Cessation CounselingBehavioural
Standard Smoking Cessation Counseling
| Study group | Role | What they receive |
|---|---|---|
| Software Assisted Lifestyle Counseling | Experimental | Not described Receives: Other: QuitAdvisorMD Software Algorithm |
| Lifestyle Counseling | Active comparator | Status quo smoking cessation counseling. Receives: Behavioral: Standard Smoking Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The goal of the evaluation is to assess the ability of QuitAdvisorMD to influence smoking cessation as measured by the primary outcome of the increase in physician initiated smoking cessation counseling.
Measured: 12 Months
Secondary outcomes (1)
Secondary outcomes will include, 1) the increase in ability of clinicians to provide appropriate stage-based smoking cessation assistance, and 2) the increase in patient quit attempts.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silverchair Science & Communications, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- George Reynolds, BA, Principal investigator, Silverchair, IncScott Strayer, MD, Principal investigator, University of Virginia Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065493
- Sponsor's protocol ID
- R44DA026682
- Other IDs
- R44DA026682
- Status last verified
- Nov 2014
- First submitted
- 8 Feb 2010
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QuitAdvisorMD: A Point-of-care Tool for Brief Smoking Cessation Interventions
- ClinicalTrials.gov ID
- NCT01065493
- Acronym / sponsor ID
- R44DA026682
- Conditions
- Smoking, Tobacco Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Silverchair Science & Communications, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2011
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
QuitAdvisorMD: A point-of-care tool for brief smoking cessation interventions Under a Phase II SBIR grant supported by NIH/NIDA, we are developing QUITAdvisorMD: a point-of-care, patient-centered resource for counseling patients who smoke or use tobacco products. It is based on the principles of Motivational Interviewing, a non-confrontational and very effective method for intervening and treating these patients; the 5 A's of behavioral interventions; and the Transtheoretical Model of Change. Through a point and click interface, the tool uses a series of interview questions designed to motivate patients to stop smoking by first assessing their stage of change and then offering effective stage-based interventions and interview techniques. The tool also offers stage-tailored patient information, a clinician educational reference, and the ability to communicate support information patients via email and/or text message.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Software Assisted Lifestyle Counseling | Experimental | Other: QuitAdvisorMD Software Algorithm |
| Lifestyle Counseling | Active comparator | Behavioral: Standard Smoking Cessation CounselingStatus quo smoking cessation counseling. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any physician providing care for members of Southern Health through primary care and have access to a point-of-care computing device (Smartphone, desktop PC, etc) during patient visits.
Key exclusion criteria (1 listed)
- Lack of appropriate computing device
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 |
|---|---|---|
| QuitAdvisorMD Software AlgorithmQuitAdvisorMD, a set of brief clinical assessments, counseling scripts and intervention instruments for smoking cessation in primary care settings | Other | Software Assisted Lifestyle Counseling |
| Standard Smoking Cessation CounselingStandard Smoking Cessation Counseling | Behavioural | Lifestyle Counseling |
Primary outcome
The goal of the evaluation is to assess the ability of QuitAdvisorMD to influence smoking cessation as measured by the primary outcome of the increase in physician initiated smoking cessation counseling.
Time frame: 12 Months
1 secondary outcome
Secondary outcomes will include, 1) the increase in ability of clinicians to provide appropriate stage-based smoking cessation assistance, and 2) the increase in patient quit attempts.
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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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.
George Reynolds, BA principal investigator
Silverchair, Inc
Scott Strayer, MD principal investigator
University of Virginia Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QuitAdvisorMD Software Algorithm and Standard Smoking Cessation Counseling in people with Smoking and Tobacco Use Disorder, run by Silverchair Science & Communications, LLC 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Nov 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The goal of the evaluation is to assess the ability of QuitAdvisorMD to influence smoking cessation as measured by the primary outcome of the increase in physician initiated smoking cessation counseling. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2014.