- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01299896
Connect to Quit for Smoking (CTQ)
February 23, 2016 updated by: University of Pittsburgh
Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans
The purpose of this research study is to examine the effectiveness of an intervention designed to reduce smoking in low income veterans within a regional United States Veterans Administration(VA) health care system.
A proactive, personalized, coordinated system of care "Connect to Quit (CTQ)" is rooted in the Chronic Care Model.
CTQ treats smoking as a chronic condition, like hypertension or diabetes, that requires long term treatment with appropriate combinations of behavioral therapy and pharmacotherapy.
CTQ will be evaluated in the context of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Approximately 40 Primary Care Providers (PCPs), including non-physicians, in the VAPHS and their patients will be recruited and randomized to either Connect to Quit (CTQ) or Usual Care (UC), existing Veterans Health Administration (VHA) services.
After PCPs are enrolled, we will begin recruiting their patients who meet eligibility criteria.
The desire to quit smoking is not required for participation in the study, as the point of CTQ is to engage smokers at every level of readiness to quit.
Target enrollment is 660 participants, approximately 330 in each treatment arm.
Participants will be followed for a minimum of 2 years and a maximum of 4. Investigators will measure abstinence (biochemically-validated, 30 day point-prevalence) throughout the study, assessed every 6 months.
Study Type
Interventional
Enrollment (Actual)
633
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15206
- VA Pittsburgh Healthcare System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female 18 years or older
- Veterans seen by a primary care physician within the VAPHS
- Household income not more than $36,000 annually
- Smoke at least 1 cigarette per day
Exclusion Criteria:
- Smokeless tobacco (snuff or chew) users
- Non-cigarette (e.g., pipe) smokers
- Non-English speaking patients
- Can not be enrolled in another smoking cessation related clinical trial at the time of enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Care
Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes.
For veterans with a co-pay, incurred fees with be reimbursed.
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Standard therapy to help participants with smoking cessation.
Other Names:
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Active Comparator: Coordinated Care
A CTQ Coordinator will coordinate the delivery of smoking related care.
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CTQ coordinators will contact the participants for various information sessions about the participant's smoking.
These participants will also receive our Connecting to Quit newsletter quarterly.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of CTQ vs UC
Time Frame: Two (2) year period
|
We will measure abstinence of CTQ smokers vs those in Usual Care (UC).
We will biochemically-validate (defined as salivary cotinine <10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.
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Two (2) year period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hilary A. Tindle, MD, MPH, Vanderbilt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
January 27, 2011
First Submitted That Met QC Criteria
February 17, 2011
First Posted (Estimate)
February 18, 2011
Study Record Updates
Last Update Posted (Estimate)
March 22, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Nicotine
- Bupropion
- Varenicline
Other Study ID Numbers
- 02936
- R01CA141596 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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