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Connect to Quit for Smoking (CTQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01299896
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : February 24, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE January 27, 2011
First Posted Date  ICMJE February 18, 2011
Results First Submitted Date  ICMJE January 21, 2016
Results First Posted Date  ICMJE February 24, 2016
Last Update Posted Date March 22, 2016
Study Start Date  ICMJE March 2011
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
Evaluate the effectiveness of CTQ vs UC [ Time Frame: Two (2) year period ]
More CTQ smokers will be abstinent (biochemically-validated 30 day point-prevalence) at the end of 2 years.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
Cost and Incremental Cost-effectiveness of CTQ vs. UC [ Time Frame: Two ( 2) year period ]
Micro-costing techniques will be used to estimate direct and indirect costs and will calculate the incremental cost per successful quit of CTQ vs. UC.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Connect to Quit for Smoking
Official Title  ICMJE Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking
  • Smoking Cessation
Intervention  ICMJE
  • Other: Coordinated Care
    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:
    • Smoking, Tobacco
    • Tobacco Smoking
    • Smoking Cessation
    • Tobacco, Intervention
    • Nicotine Replacement
    • Buproprion, Wellbutrin
    • Chantix, Varenicline
    • Behavorial therapy
  • Other: Usual Care
    Standard therapy to help participants with smoking cessation.
    Other Names:
    • Smoking, Tobacco
    • Tobacco Smoking
    • Smoking Cessation
    • Tobacco, Intervention
    • Nicotine Replacement
    • Buproprion, Wellbutrin
    • Chantix, Varenicline
    • Behavorial therapy
Study Arms  ICMJE
  • 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.
    Intervention: Other: Usual Care
  • Active Comparator: Coordinated Care
    A CTQ Coordinator will coordinate the delivery of smoking related care.
    Intervention: Other: Coordinated Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
633
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2011)
660
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01299896
Other Study ID Numbers  ICMJE 02936
R01CA141596 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Hilary A. Tindle, MD, MPH Vanderbilt University
PRS Account University of Pittsburgh
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP