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Connect to Quit for Smoking (CTQ)

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Smoking
Smoking Cessation
Interventions Other: Coordinated Care
Other: Usual Care
Enrollment 633
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Care Coordinated Care
Hide Arm/Group Description

Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (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.

Usual Care: Standard therapy to help participants with smoking cessation.

A CTQ Coordinator will coordinate the delivery of smoking related care.

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.

Period Title: Overall Study
Started 319 314
Completed 318 296
Not Completed 1 18
Reason Not Completed
Withdrawal by Subject             1             7
Lost to Follow-up             0             11
Arm/Group Title Usual Care Coordinated Care Total
Hide Arm/Group Description

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.

Usual Care: Standard therapy to help participants with smoking cessation.

A CTQ Coordinator will coordinate the delivery of smoking related care.

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.

Total of all reporting groups
Overall Number of Baseline Participants 319 314 633
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 319 participants 314 participants 633 participants
54.7  (11.5) 55.7  (8.7) 55.2  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 319 participants 314 participants 633 participants
Female
28
   8.8%
38
  12.1%
66
  10.4%
Male
291
  91.2%
276
  87.9%
567
  89.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 319 participants 314 participants 633 participants
319 314 633
1.Primary Outcome
Title Effectiveness of CTQ vs UC
Hide Description 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.
Time Frame Two (2) year period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Coordinated Care
Hide Arm/Group Description:

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.

Usual Care: Standard therapy to help participants with smoking cessation.

A CTQ Coordinator will coordinate the delivery of smoking related care.

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.

Overall Number of Participants Analyzed 319 314
Measure Type: Number
Unit of Measure: percentage of participants per arm
7.5 6.1
Time Frame Events were collected starting at day 0 and continuing at six month intervals for a minimum of two years maximum 4 years pending date of enrollment.
Adverse Event Reporting Description Hospitalization is the most common serious adverse event for our study population because hospitalization is common among smokers. Serious adverse events were obtained during follow up assessments and/or through chart extraction.
 
Arm/Group Title Usual Care Coordinated Care
Hide Arm/Group Description

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.

Usual Care: Standard therapy to help participants with smoking cessation.

A CTQ Coordinator will coordinate the delivery of smoking related care.

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.

All-Cause Mortality
Usual Care Coordinated Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Coordinated Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   181/319 (56.74%)      175/314 (55.73%)    
General disorders     
Hospitalization   157/319 (49.22%)  162/314 (51.59%) 
Death   24/319 (7.52%)  13/314 (4.14%)  295
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Coordinated Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/319 (0.00%)      0/314 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Hilary A. Tindle
Organization: Vanderbilt University
Phone: 615-875-9726
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01299896     History of Changes
Other Study ID Numbers: 02936
R01CA141596 ( U.S. NIH Grant/Contract )
First Submitted: January 27, 2011
First Posted: February 18, 2011
Results First Submitted: January 21, 2016
Results First Posted: February 24, 2016
Last Update Posted: March 22, 2016